SYK » Topics » Hip Implant Systems

These excerpts taken from the SYK 10-K filed Feb 20, 2009.

Hip Implant Systems

Through Stryker Orthopaedics, the Company offers a variety of hip implant systems for the global reconstructive market including primary (or first-time) and revision (to repair or enhance a previous replacement) hip systems as well as less invasive hip systems. 

            In 2007 the Company began selling the Cormet Hip Resurfacing System in the United States pursuant to an exclusive 10-year marketing and distribution agreement with Corin Group PLC.  In 2006 the Company began the launch of the MITCH TRH System in certain international markets.  These products represent a less invasive, joint preserving hip resurfacing option for younger patients with the potential for enhanced stability and range of motion.  In hip resurfacing procedures, very little bone is removed from the femoral head, the femoral neck is preserved and the femoral canal is spared.  MIS approaches combined with hip resurfacing products and related surgical instrumentation offer the promise of less soft tissue trauma, reduced pain and improved recovery times. 

            The Company offers a comprehensive system of cementless stems, cemented stems and acetabular cups for each of its primary hip implant technologies, including ABG, Partnership, Secur-Fit, Omnifit, Accolade, Exeter and Trident hip systems. These systems, along with associated surgical instrumentation, are designed to provide personalized solutions based on the patient's unique anatomy while streamlining the implant procedure to improve surgical efficiencies.  Each of these systems includes a portfolio of primary stem options based on multiple fixation philosophies including anatomic, fit/fill, taper wedge and double-tapered designs.  In addition, acetabular systems including the Trident and ABG Acetabular systems provide a variety of options for achieving initial and long term fixation.  In 2008 the Company introduced the Tritanium Primary acetabular system.  This system provides an advanced fixation technology offering a pure titanium matrix designed to improve bone ingrowth. 

            Following the clinical success of its Crossfire technology, a highly crosslinked polyethylene designed to reduce wear, Stryker introduced X3 polyethylene.  X3 polyethylene is the Company's next-generation highly crosslinked polyethylene, which features a higher level of strength and wear reduction in both hip and knee replacements.   Building on the strength of the X3 product offering, the Company introduced Low Friction Ion Treatment (LFIT) and Delta Anatomic Femoral Heads with X3 polyethylene liners.  These bearing combinations represent an advancement in hip-bearing technology that in combination are anatomically sized for more natural hip performance while offering even greater options to reduce wear and potentially increase implant longevity. The Company received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in 2003 for its ceramic-on-ceramic hip replacement system, the Trident Ceramic Acetabular Insert, for patients in the United States.  Stryker Orthopaedics has successfully launched the Trident ceramic insert in the United States, Europe, Australia and Canada.  The Trident insert is wear resistant, and it is protected and strengthened by a patented titanium sleeve.

            The Company offers a number of products designed to meet the needs of revision hip procedures including Restoration, Restoration Modular, Trident Tritanium Revision, and Dall-Miles each of which provides surgeons with the options necessary to address revision surgery challenges.  The Restoration Modular Revision Hip System offers surgeons performing revision surgeries flexibility in treating complex hip stem revisions and restoring patient biomechanics.  The Restoration Modular Revision Hip System also takes advantage of Stryker's long clinical history with hydroxylapatite (HA), a naturally occurring calcium phosphate material that demonstrates a high level of biocompatibility due to its resemblance to bone, by incorporating PureFix HA coating on many components.  The Restoration Modular Revision Hip System enhances the Company's existing Restoration HA and Restoration plasma spray (PS) monolithic revision systems.  The Restoration System is complemented by the Trident Tritanium Acetabular Cup, a biologically inspired, commercially pure titanium ingrowth surface designed to provide solid initial fixation and promote bone ingrowth.  Coupled with the availability of the Dall-Miles System for trochanteric reattachment and cerclage fixation, Stryker's revision portfolio offers comprehensive solutions to address challenges encountered in revision surgery.

 

- 7 - 


 

            Stryker was the first company to receive clearance from the FDA to commercially release for sale in the United States a hip implant with HA surface treatment.  The Company's global clinical experience with HA-coated hip stems now extends over 20 years, and reported clinical performance continues to equal or exceed that of comparable hip stems reported in the scientific literature.

            The Company's CentPillar Hip System offers an increased range of motion and a minimally invasive technique preferred by Japanese surgeons for their patients.  In 2007 the Company introduced CentPillar TMZF to the Japanese market.  This is the first product introduced in Japan that utilizes Stryker's patented TMZF material along with the Company's PureFix HA.  The TMZF material allows for implant stiffness more closely matched to a patient's own bone to enhance fixation. 

            The Company entered 2009 with more than 30 years of clinical history with the Exeter Hip System, more than 20 years of clinical history with the Omnifit cemented stem and more than 20 years of clinical history with the Omnifit HA stem.  Long-term clinical results are an important factor in the Company's ability to market hip implants. 

Hip Implant Systems





Through
Stryker Orthopaedics, the Company offers a variety of hip implant systems for
the global reconstructive market including primary (or first-time) and revision
(to repair or enhance a previous replacement) hip systems as well as less
invasive hip systems. 





            In
2007 the Company began selling the Cormet Hip Resurfacing System in the United States pursuant to an exclusive 10-year marketing and distribution agreement with
Corin Group PLC.  In 2006 the Company began the launch of the MITCH TRH System
in certain international markets.  These products represent a less invasive, joint
preserving hip resurfacing option for younger patients with the potential for
enhanced stability and range of motion.  In hip resurfacing procedures, very
little bone is removed from the femoral head, the femoral neck is preserved and
the femoral canal is spared.  MIS approaches combined with hip resurfacing
products and related surgical instrumentation offer the promise of less soft
tissue trauma, reduced pain and improved recovery times. 





            The
Company offers a comprehensive system of cementless stems, cemented stems and
acetabular cups for each of its primary hip implant technologies, including
ABG, Partnership, Secur-Fit, Omnifit, Accolade, Exeter and Trident hip systems.
These systems, along with associated surgical instrumentation, are designed to
provide personalized solutions based on the patient's unique anatomy while
streamlining the implant procedure to improve surgical efficiencies.  Each of
these systems includes a portfolio of primary stem options based on multiple
fixation philosophies including anatomic, fit/fill, taper wedge and
double-tapered designs.  In addition, acetabular systems including the Trident
and ABG Acetabular systems provide a variety of options for achieving initial
and long term fixation.  In 2008 the Company introduced the Tritanium Primary acetabular
system.  This system provides an advanced fixation technology offering a pure
titanium matrix designed to improve bone ingrowth. 





            Following
the clinical success of its Crossfire technology, a highly crosslinked
polyethylene designed to reduce wear, Stryker introduced X3 polyethylene.  X3
polyethylene is the Company's next-generation highly crosslinked polyethylene,
which features a higher level of strength and wear reduction in both hip and
knee replacements.   Building on the strength of the X3 product offering, the
Company introduced Low Friction Ion Treatment (LFIT) and Delta Anatomic Femoral
Heads with X3 polyethylene liners.  These bearing combinations represent an advancement
in hip-bearing technology that in combination are anatomically sized for more
natural hip performance while offering even greater options to reduce wear and
potentially increase implant longevity. The Company received premarket approval
(PMA) from the U.S. Food and Drug Administration (FDA) in 2003 for its
ceramic-on-ceramic hip replacement system, the Trident Ceramic Acetabular
Insert, for patients in the United States.  Stryker Orthopaedics has
successfully launched the Trident ceramic insert in the United States, Europe, Australia and Canada.  The Trident insert is wear resistant, and it is
protected and strengthened by a patented titanium sleeve.






            The
Company offers a number of products designed to meet the needs of revision hip
procedures including Restoration, Restoration Modular, Trident Tritanium
Revision, and Dall-Miles each of which provides surgeons with the options
necessary to address revision surgery challenges.  The Restoration Modular
Revision Hip System offers surgeons performing revision surgeries flexibility
in treating complex hip stem revisions and restoring patient biomechanics.  The
Restoration Modular Revision Hip System also takes advantage of Stryker's long
clinical history with hydroxylapatite (HA), a naturally occurring calcium
phosphate material that demonstrates a high level of biocompatibility due to
its resemblance to bone, by incorporating PureFix HA coating on many
components.  The Restoration Modular Revision Hip System enhances the Company's
existing Restoration HA and Restoration plasma spray (PS) monolithic revision
systems.  The Restoration System is complemented by the Trident Tritanium
Acetabular Cup, a biologically inspired, commercially pure titanium ingrowth
surface designed to provide solid initial fixation and promote bone ingrowth. 
Coupled with the availability of the Dall-Miles System for trochanteric
reattachment and cerclage fixation, Stryker's revision portfolio offers
comprehensive solutions to address challenges encountered in revision surgery.


 



- - 7 - 









 



            Stryker
was the first company to receive clearance from the FDA to commercially release
for sale in the United States a hip implant with HA surface treatment.  The
Company's global clinical experience with HA-coated hip stems now extends over
20 years, and reported clinical performance continues to equal or exceed that
of comparable hip stems reported in the scientific literature.





            The
Company's CentPillar Hip System offers an increased range of motion and a
minimally invasive technique preferred by Japanese surgeons for their
patients.  In 2007 the Company introduced CentPillar TMZF to the Japanese
market.  This is the first product introduced in Japan that utilizes Stryker's
patented TMZF material along with the Company's PureFix HA.  The TMZF material
allows for implant stiffness more closely matched to a patient's own bone to
enhance fixation. 





            The
Company entered 2009 with more than 30 years of clinical history with the
Exeter Hip System, more than 20 years of clinical history with the Omnifit
cemented stem and more than 20 years of clinical history with the Omnifit HA
stem.  Long-term clinical results are an important factor in the Company's
ability to market hip implants. 





These excerpts taken from the SYK 10-K filed Feb 28, 2008.

Hip Implant Systems

 

Through Stryker Orthopaedics, the Company offers a variety of hip implant systems for the global reconstructive market.  The ABG Hip System, Partnership Hip System, Secur-Fit Hip System, Omnifit Hip System, Accolade Hip System and Restoration Hip System are all comprehensive systems of hip implants and associated instrumentation designed to provide physicians and patients with reliable results and to reduce operating time for primary and revision procedures.  The Exeter Total Hip System is based on a collarless, highly polished, double-tapered femoral design that reduces shear stresses and increases compression at the cement/bone interface.  During 2004, the Company began transitioning to its new Restoration Modular Revision Hip System in the United States, Europe, Australia and Canada.  This system offers surgeons performing revision surgeries flexibility in treating complex hip stem revisions and restoring patient biomechanics.  The Restoration Modular Revision Hip System also takes advantage of Stryker's long clinical history with hydroxylapatite (HA), a naturally occurring calcium phosphate material that demonstrates a high level of biocompatibility due to its resemblance to bone, by incorporating PureFix HA coating on many components.  The Restoration Modular Revision Hip System complements the Company's existing Restoration HA and Restoration plasma spray (PS) monolithic revision systems.

 

In 2007 the Company began selling the Cormet Hip Resurfacing System in the United States pursuant to an exclusive 10-year marketing and distribution agreement with Corin Group PLC.  In 2006 the Company began the initial launch of another hip resurfacing product in certain international markets.  These products represent a less invasive option for younger patients with the potential for enhanced stability and range of motion.  In hip resurfacing procedures, very little bone is removed from the femoral head, the femoral neck is preserved and the femoral canal is spared.

 

Following the clinical success of its Crossfire technology, a highly crosslinked polyethylene designed to reduce wear, Stryker launched X3 polyethylene in 2005.  X3 polyethylene is the Company's next-generation highly crosslinked polyethylene, which features a higher level of strength and wear reduction in both hip and knee replacements.

 

- 7 -


 

In 2006 the Company received clearance from the FDA for its advanced bearing system, Low Friction Ion Treatment (LFIT) Anatomic Femoral Heads with X3 polyethylene liners.  This represents a significant advancement in hip-bearing technology through the combination of Stryker's LFIT technology and X3 advanced bearing technology.  The femoral heads are anatomically sized for more natural hip performance.  In 2007 the Company further expanded its anatomic femoral head offerings with the introduction of the Delta Ceramic Anatomic head for even greater options to reduce wear and potentially increase implant longevity.

 

            Stryker was the first company to receive clearance from the FDA to commercially release for sale in the United States a hip implant with HA surface treatment.  The Company's global clinical experience with HA-coated hip stems now extends over 20 years, and reported clinical performance continues to equal or exceed that of comparable hip stems reported in the scientific literature.

 

            The Company's CentPillar Hip System provide lines of products that offer an increased range of motion and a minimally invasive technique preferred by Japanese surgeons for their patients.  In 2007 the Company introduced CentPillar TMZF to the Japanese market.  This is the first product introduced in Japan that utilizes Stryker's patented TMZF material along with the Company's PureFix HA.  The TMZF material allows for implant stiffness more closely matched to a patient's own bone to enhance fixation.

 

            The Company received premarket approval (PMA) from the FDA in 2003 for its ceramic-on-ceramic hip replacement system, the Trident Ceramic Acetabular Insert, for patients in the United States.  Stryker Orthopaedics has successfully launched the Trident ceramic insert in the United States, Europe, Australia and Canada.  The Trident insert is wear resistant, and it is protected and strengthened by a patented titanium sleeve.  In 2006 the Company launched the Trident Tritanium Acetabular Shell which contains a highly porous surface that closely resembles the structure of trabecular bone.  This shell is designed for revision surgery and contains multiple screw holes to achieve bone fixation and initial stability.

 

The Company entered 2008 with more than 30 years of clinical history with the Exeter Hip System, more than 20 years of clinical history with the Omnifit cemented stem and more than 20 years of clinical history with the Omnifit HA stem.  Long-term clinical results are an important factor in the Company's ability to market hip implants.

 

Hip Implant Systems


 





Through
Stryker Orthopaedics, the Company offers a variety of hip implant systems for
the global reconstructive market.  The ABG Hip System, Partnership Hip System,
Secur-Fit Hip System, Omnifit Hip System, Accolade Hip System and Restoration
Hip System are all comprehensive systems of hip implants and associated
instrumentation designed to provide physicians and patients with reliable
results and to reduce operating time for primary and revision procedures.  The
Exeter Total Hip System is based on a collarless, highly polished,
double-tapered femoral design that reduces shear stresses and increases
compression at the cement/bone interface.  During 2004, the Company began
transitioning to its new Restoration Modular Revision Hip System in the United States, Europe, Australia and Canada.  This system offers surgeons performing revision
surgeries flexibility in treating complex hip stem revisions and restoring
patient biomechanics.  The Restoration Modular Revision Hip System also takes
advantage of Stryker's long clinical history with hydroxylapatite (HA), a
naturally occurring calcium phosphate material that demonstrates a high level of
biocompatibility due to its resemblance to bone, by incorporating PureFix HA
coating on many components.  The Restoration Modular Revision Hip System
complements the Company's existing Restoration HA and Restoration plasma spray
(PS) monolithic revision systems.


 





In
2007 the Company began selling the Cormet Hip Resurfacing System in the United States pursuant to an exclusive 10-year marketing and distribution agreement with
Corin Group PLC.  In 2006 the Company began the initial launch of another hip
resurfacing product in certain international markets.  These products represent
a less invasive option for younger patients with the potential for enhanced
stability and range of motion.  In hip resurfacing procedures, very little bone
is removed from the femoral head, the femoral neck is preserved and the femoral
canal is spared.


 





Following
the clinical success of its Crossfire technology, a highly crosslinked
polyethylene designed to reduce wear, Stryker launched X3 polyethylene in
2005.  X3 polyethylene is the Company's next-generation highly crosslinked
polyethylene, which features a higher level of strength and wear reduction in
both hip and knee replacements.


 


- 7 -







 


In 2006
the Company received clearance from the FDA for its advanced bearing system, Low
Friction Ion Treatment (LFIT) Anatomic Femoral Heads with X3 polyethylene
liners.  This represents a significant advancement in hip-bearing technology through
the combination of Stryker's LFIT technology and X3 advanced bearing technology. 
The femoral heads are anatomically sized for more natural hip performance.  In
2007 the Company further expanded its anatomic femoral head offerings with the
introduction of the Delta Ceramic Anatomic head for even greater options to
reduce wear and potentially increase implant longevity.


 






            Stryker
was the first company to receive clearance from the FDA to commercially release
for sale in the United States a hip implant with HA surface treatment.  The
Company's global clinical experience with HA-coated hip stems now extends over 20
years, and reported clinical performance continues to equal or exceed that of
comparable hip stems reported in the scientific literature.


 






            The Company's
CentPillar Hip System provide lines of products that offer an increased range
of motion and a minimally invasive technique preferred by Japanese surgeons for
their patients.  In 2007 the Company introduced CentPillar TMZF to the Japanese
market.  This is the first product introduced in Japan that utilizes Stryker's
patented TMZF material along with the Company's PureFix HA.  The TMZF material
allows for implant stiffness more closely matched to a patient's own bone to
enhance fixation.


 






            The
Company received premarket approval (PMA) from the FDA in 2003 for its
ceramic-on-ceramic hip replacement system, the Trident Ceramic Acetabular
Insert, for patients in the United States.  Stryker Orthopaedics has successfully
launched the Trident ceramic insert in the United States, Europe, Australia and Canada.  The Trident insert is wear resistant, and it is protected and strengthened by
a patented titanium sleeve.  In 2006 the Company launched the Trident Tritanium
Acetabular Shell which contains a highly porous surface that closely resembles
the structure of trabecular bone.  This shell is designed for revision surgery
and contains multiple screw holes to achieve bone fixation and initial
stability.


 





The
Company entered 2008 with more than 30 years of clinical history with the
Exeter Hip System, more than 20 years of clinical history with the Omnifit
cemented stem and more than 20 years of clinical history with the Omnifit HA
stem.  Long-term clinical results are an important factor in the Company's
ability to market hip implants.


 





This excerpt taken from the SYK 10-K filed Feb 28, 2007.

Hip Implant Systems

Through Stryker Orthopaedics, the Company offers a variety of hip implant systems for the global reconstructive market.  The ABG Hip System, Partnership Hip System, Secur-Fit Hip System, Omnifit Hip System, Accolade Hip System and Restoration Hip System are all comprehensive systems of hip implants and associated instrumentation designed to provide physicians and patients with reliable results and to reduce operating time for primary and revision procedures.  The Exeter Total Hip System is based on a collarless, highly polished, double-tapered femoral design that reduces shear stresses and increases compression at the cement/bone interface.  During 2004, the Company began transitioning to its new Restoration Modular Revision Hip System in the United States, Europe, Australia and Canada.  This system offers surgeons performing revision surgeries flexibility in treating complex hip stem revisions and restoring patient biomechanics.  The Restoration Modular Revision Hip System also takes advantage of Stryker's long clinical history with hydroxylapatite (HA), a naturally occurring calcium phosphate material that demonstrates a high level of biocompatibility due to its resemblance to bone, by incorporating PureFix HA coating on many components.  The Restoration Modular Revision Hip System complements the Company's existing Restoration HA and Restoration plasma spray (PS) monolithic revision systems.

In 2006, the Company announced that it received clearance from the FDA for its advanced bearing system, LFIT Anatomic Femoral Heads with X3 polyethylene liners.  This represents a significant advancement in hip bearing technology with the combination of Stryker's Low Friction Ion Treatment (LFIT) technology and X3 advanced bearing technology.  The femoral heads are anatomically sized for more natural hip performance.

Following the clinical success of its Crossfire technology, a highly crosslinked polyethylene designed to reduce wear, Stryker launched X3 polyethylene in 2005.  X3 polyethylene is the Company's next-generation highly crosslinked polyethylene and features a higher level of strength and wear reduction in both hip and knee replacements.     

Stryker was the first company to receive clearance from the FDA to commercially release for sale in the United States a hip implant with HA surface treatment.  The Company's global clinical experience with HA-

- 7 -


coated hip stems now extends over 20 years and reported clinical performance continues to equal or exceed that of comparable hip stems reported in the scientific literature.

The Company began a limited launch of its CentPillar Hip System in the Japanese market in 2003, with a full rollout in 2004.  The Taro Hip System and CentPillar Hip System provide lines of products that offer an increased range of motion and a minimally invasive technique preferred by Japanese surgeons for their patients.   

The Company received premarket approval (PMA) from the FDA in 2003 for its ceramic-on-ceramic hip replacement system, the Trident Ceramic Acetabular Insert, for patients in the United States.  Stryker Orthopaedics has successfully launched the Trident ceramic insert in the United States, Europe, Australia and Canada.  The Trident insert is wear resistant, and it is protected and strengthened by a patented titanium sleeve.  In 2006, the Company launched the Trident Tritanium Acetabular Shell which contains a highly porous surface that closely resembles the structure of trabecular bone.  This shell is designed for revision surgery and contains multiple screw holes to achieve bone fixation and initial stability.  Other technologies used for total hip replacement include metal-on-conventional polyethylene and metal-on-highly crosslinked polyethylene articulations.

The Company entered 2007 with more than 30 years of clinical history with the Exeter Hip System, more than 20 years of clinical history with the Omnifit cemented stem and more than 20 years of clinical history with the Omnifit HA stem.  Long-term clinical results are an important factor in the Company's ability to market hip implants.

This excerpt taken from the SYK 10-K filed Mar 7, 2006.

Hip Implant Systems

 

Through Stryker Orthopaedics, the Company offers a variety of hip implant systems for the global reconstructive market.  The ABG Hip System, Partnership Hip System, Secur-Fit Hip System, Omnifit Hip System, Accolade Hip System and Restoration Hip System each represents a comprehensive system of hip implants and associated instrumentation designed to provide physicians and patients with reliable results and to reduce operating time for primary and revision procedures.  The Exeter Total Hip System is based on a unique, collarless, highly polished, double-tapered femoral design that reduces shear stresses and increases compression at the cement/bone interface.  During 2004, the Company began transitioning to its new Restoration Modular Revision Hip System in the United States, Europe, Australia and Canada.  This system offers surgeons performing revision surgeries flexibility in treating complex stem revisions and restoring patient biomechanics.  The Restoration Modular Revision Hip System also takes advantage of Stryker's long clinical history with hydroxylapatite (HA), a naturally occurring calcium phosphate material that demonstrates a high level of biocompatibility due to its resemblance to bone, by incorporating PureFix HA coating on many components.  The Restoration Modular Revision Hip System complements the Company's existing Restoration HA and Restoration PS monolithic revision systems.

 

Stryker was the first company to receive clearance from the United States Food and Drug Administration (FDA) to commercially release for sale in the United States a hip implant with HA surface treatment.  The Company's global clinical experience with HA-coated hip stems now extends over 15 years and reported clinical performance continues to equal or exceed that of comparable hip stems reported in the scientific literature.

 

Following the clinical success of its Crossfire technology, a highly crosslinked polyethylene designed to reduce wear, Stryker launched X3 Polyethylene in 2005.  X3 Polyethylene is the Company's next-generation highly crosslinked polyethylene and features a higher level of strength and wear reduction in both hip and knee replacements. 

    

The Company began a limited launch of its CentPillar Hip System in the Japanese market in 2003, with a full rollout in 2004.  The Taro Hip System and CentPillar Hip System provide lines of products that offer an increased range of motion and a minimally invasive technique preferred by Japanese surgeons for their patients.   

 

On February 3, 2003, the Company received premarket approval (PMA) from the FDA for its ceramic-on-ceramic hip replacement system, the Trident Ceramic Acetabular Insert, for patients in the United States.  Stryker Orthopaedics successfully launched the Trident ceramic insert in the United States in the second quarter of 2003 following successful launches in Europe, Australia and Canada.  The Trident insert is wear resistant, and it is protected and strengthened by a patented titanium sleeve.  Other technologies used for total hip replacement include metal-on-conventional polyethylene and metal-on-highly crosslinked polyethylene articulations.

 

The Company entered 2006 with more than 30 years of clinical history with the Exeter Hip System, more than 20 years of clinical history with the Omnifit cemented stem and 15 years of clinical history with the Omnifit HA stem.  Long-term clinical results are an important factor in the Company's ability to market hip implants. 

 

This excerpt taken from the SYK 10-K filed Mar 2, 2005.

Hip Implant Systems

 

Through Stryker Orthopaedics, the Company offers a variety of hip systems for the global reconstructive market.  The ABG Hip System, Partnership Hip System, Secur-Fit Hip System, Omnifit Hip System, Accolade Hip System and Restoration Hip System each represents a comprehensive system of hip implants and associated instrumentation designed to provide physicians and patients with reliable results and to reduce operating time for primary and revision procedures.  The Exeter Total Hip System is based on a unique, collarless, highly polished, double-tapered femoral design that reduces shear stresses and increases compression at the cement/bone interface.  During 2004, the Company began transitioning to its new Restoration Modular Revision Hip System in the United States, Europe, Australia and Canada.  This system offers the revision surgeon flexibility in treating complex stem revisions and restoring patient biomechanics.  The Restoration Modular Revision Hip System also takes advantage of Stryker's long clinical history with hydroxylapatite (HA), a naturally occurring calcium phosphate material that demonstrates a high level of biocompatibility due to its resemblance to bone, by incorporating PureFix HA coating on many components.  The Restoration Modular Revision Hip System complements the Company's existing Restoration HA and Restoration PS monolithic revision systems.

 

Stryker was the first company to receive clearance from the FDA to commercially release for sale in the United States a hip implant with HA surface treatment.  The Company's global clinical experience with HA-coated hip stems now extends over 15 years, and reported clinical performance continues to equal or exceed that of comparable hip stems reported in the scientific literature.

 

The Company began a limited launch of its CentPillar Hip System in the Japanese market in 2003, with a full rollout in 2004.  The Taro Hip System and CentPillar Hip System provide lines of products that offer an increased range of motion and a minimally invasive technique preferred by Japanese surgeons for their patients.   

 

On February 3, 2003, the Company received premarket approval (PMA) from the FDA for its ceramic-on-ceramic hip replacement system, the Trident Ceramic Acetabular Insert, for patients in the United States.  Stryker Orthopaedics successfully launched the Trident ceramic insert in the United States in the second quarter of 2003 following successful launches in Europe, Australia and Canada in 2002.  The Trident insert is wear resistant, and it is protected and strengthened by a patented titanium sleeve.  Other technologies used for total hip replacement include metal-on-conventional polyethylene and metal-on-highly crosslinked polyethylene (Crossfire) articulations.  By the end of 2004, approximately 61% of the Company's acetabular inserts sold in the United States utilized Crossfire technology, a highly cross-linked polyethylene designed to reduce wear, and approximately 35% of the inserts utilized the Company's ceramic insert technology.

 

In 2002, the Company launched the Trident Acetabular Cup system.  This patented design, which allows for the use of either polyethylene inserts or ceramic inserts, positioned the Company well for the launch of its ceramic acetabular products in the United States in 2003.  Trident's two independent locking mechanisms provide maximum security for each bearing surface and increase the strength of the ceramic liner.  Also released in 2002 was the Accolade C-Cemented stem.  This stem complements the Accolade TMZF cementless stem launched in 2001 and incorporates many of the same innovative design features for use with cemented stems.  Accolade C utilizes the simple and efficient Accolade instrumentation system.

 

The Company entered 2005 with more than 30 years of clinical history with the Exeter Hip System, more than 20 years of clinical history with the Omnifit cemented stem and 15 years of clinical history with the Omnifit HA stem.  Long-term clinical results are an important factor in the Company's ability to market hip implants. 

 

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