Did You Know?
The Pinnacle Cup System has been provided for nearly one million patients
Use our downloadable PDFs to educate your patients on PINNACLE.
PINNACLE® Acetabular Cup System
Musculoskeletal diseases, characterized by chronic joint and back pain, are the nation's leading cause of disability and place a major, under-reported burden on communities and the economy. According to the Centers for Disease Control, 21 million American adults have arthritis-attributed activity limitation. Joint or spine disorders are the primary diagnoses for doctor office visits, according to a 2007 National Ambulatory Medical Care survey.
A Leader in Hip Replacement
The first orthopaedic company in the United States, DePuy Orthopaedics has been a leader in hip replacement for more than 40 years. Our mission is to develop products and technologies that help patients who have been affected by pain, disability and a loss of mobility return to their daily activities.
The PINNACLE® Cup System
For more than 10 years, the PINNACLE® Acetabular Cup System has been one of the most widely used and clinically successful modular acetabular cup systems for hip replacement. Since its first implantation, the PINNACLE Cup System has been provided for nearly one million patients, helping to reduce pain and restore mobility. The PINNACLE Cup System has a strong track record of helping to reduce pain and restore mobility for those suffering from chronic pain.
Complete with a wide range of acetabular cup options, biological and mechanical fixation alternatives and advanced bearing technologies, the PINNACLE Cup System allows surgeons the flexibility to choose intraoperatively from among the most advanced technologies available – ceramic-on-polyethylene, metal-on-polyethylene, ceramic-on-ceramic, metal-on-metal, and ceramic-on-metal bearing surfaces – depending on their patients' individual needs.
Learn more about the options available with the PINNACLE Acetabular Cup System by clicking the Options tab above.
Commitment to Innovation
DePuy continues to advance bearing technology, design and materials within the PINNACLE Acetabular Cup System. In 2010-2011 alone, DePuy obtained Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) to offer two newly developed bearing surfaces offered within the PINNACLE System – the CERAMAX® Ceramic-on-Ceramic and COMPLETE® Ceramic-on-Metal Hip Systems. Pre-Market Approval is one of the highest levels of approval for a medical device by FDA, requiring clinical data for evidence of safety and efficacy. The PINNACLE System is the only acetabular cup system with two approved PMAs.
The most recent of these PMAs was FDA's approval of DePuy Orthopaedics' PINNACLE COMPLETE Acetabular Hip System, the industry's first and only ceramic-on-metal hip bearing approved for sale in the United States. The approval of the COMPLETE System marks another important milestone in the successful heritage of PINNACLE, further demonstrating DePuy's commitment to advancing bearing technology, design, materials and manufacturing.
Did You Know?
PINNACLE® is the only modular acetabular cup system that provides five bearing options in the U.S.
Use our downloadable PDFs to educate your patients on PINNACLE.
Options for Your Patients
The PINNACLE® Acetabular Cup System was designed with a wide range of acetabular cup options, biological and mechanical fixation alternatives and advanced bearing technologies. Designed and developed in consultation with experienced orthopaedic surgeons and leaders in the biomedical field, the PINNACLE Cup System allows surgeons the flexibility to choose intraoperatively from among the most advanced technologies available – ceramic-on-polyethylene, metal-on-polyethylene, ceramic-on-ceramic, metal-on-metal, or ceramic-on-metal bearing surfaces – depending on their patients' individual needs.
Metal-on-polyethylene
The most commonly used bearing option, metal-on-polyethylene is durable and versatile for precise insertion. Polyethylene accommodates various femoral head sizes, so surgeons can choose the implant that meets the needs of each individual patient.
Learn more about our metal-on-polyethylene options by clicking the Polyethylene tab above:
ALTRX® Polyethylene Liners MARATHON® Cross-Linked Polyethylene
Ceramic-on-polyethylene
The ceramic bearing used in the PINNACLE Acetabular Cup System ceramic-on-polyethylene hip replacement is extremely hard and very smooth, reducing wear on the polyethylene liner by reducing friction as the implant moves. Ceramic is also biologically inert, meaning it is tolerated well in the human body.
Learn more about our ceramic-on-polyethylene option:
Ceramic Femoral Heads from BIOLOX® delta, a trademark of CeramTec AG
Metal-on-metal Used since joint replacement began in the U.S. in the 1960's, metal-on-metal hip replacements allow for greater range of motion and stability with options that feature larger head-to-cup ratios.
Learn more about our metal-on-metal options:
ULTAMET® Metal-on-Metal Articulation System Learn more on Considerations with metal-on-metal technology by clicking the Metal tab above:
Ceramic-on-metal Approved by the U.S. Food and Drug Administration (FDA) in 2011, DePuy's PINNACLE COMPLETE® Acetabular Hip System is the first ceramic-on-metal hip implant available in the United States.
The FDA approval of the COMPLETE System was based in part on results from a two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing.
Learn more about DePuy Orthopaedics' ceramic-on-metal option:
COMPLETE Acetabular Hip System
Ceramic-on-ceramic
The CERAMAX® Ceramic Total Hip System features a new generation of ceramic material designed for use in hip replacement surgery, BIOLOX® delta. Approved through the FDA's PMA process.
Learn more about our ceramic-on-ceramic option by clicking the Ceramic tab above:
Did You Know?
Marathon was the first FDA cleared cross-linked polythylene in orthopaedics
Use our downloadable PDFs to educate your patients on PINNACLE.
PINNACLE Polyethylene Options
ALTRX™ and MARATHON® polyethylene liners were designed to work with the PINNACLE® Acetabular Cup System, which provides a range of acetabular cup options, fixation alternatives and advanced bearing technologies. This gives surgeons the ability to choose the precise combination of implants that best meets the individual needs of each patient.
A Solid Foundation
ALTRX™ was built on the proven clinical heritage of MARATHON® cross-linked polyethylene. Introduced in 1998, MARATHON was the first FDA-cleared cross-linked polyethylene in orthopaedics.
Through the exclusive Altra-Link™ material enhancement process, ALTRX polyethylene was optimized to balance wear reduction and mechanical integrity while eliminating oxidation.1,2
Wear Resistance
To address a growing trend toward high-demand patients, ALTRX polyethylene liners were developed to reduce wear by 92 percent versus standard polyethylene and 51 percent versus MARATHON polyethylene liners.1,2 With a focus on wear reduction, ALTRX liners are potentially less susceptible to higher wear as a function of head size.2 Reduced wear claims are based on the results of in-vitro hip wear simulator tests which have not been shown to quantitatively predict clinical performance.
1Liao, Y.-S., K. Greer, et al. "Effects of Resin and Dose on Wear and Mechanical Properties of Cross-linked Thermally Stabilized UHMWPE." Society for Biomaterials, the 7th World Biomaterials Congress, Sydney, Australia, 2004.
2Data on file, DePuy Orthopaedics, Inc.
Did You Know?
PINNACLE® is the only modular acetabular cup system that provides five bearing options in the U.S.
Use our downloadable PDFs to educate your patients on PINNACLE.
CERAMAX® Ceramic Total Hip System
Featuring a new generation of ceramic material designed for use in hip replacement surgery, the CERAMAX® Ceramic Total Hip System is a ceramic-on-ceramic bearing using BIOLOX® delta, the fourth generation of BIOLOX Ceramic, whose three previous versions have been used in millions of implants throughout the world.1
The CERAMAX Ceramic Total Hip System, approved through the FDA's PMA process, is indicated for cementless total hip replacement in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of hips damaged as a result of non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis and post-traumatic arthritis.
The safety and efficacy of the new device was evaluated in an FDA-approved blinded, randomized prospective study of 264 patients who required hip replacement surgery for severe osteoarthritis. More than half the patients (177) received the CERAMAX Hip and 87 patients received a conventional ceramic-on-polyethylene hip. Patients had follow-up clinical examinations at six weeks, six months, 12 months and 24 months following their surgeries.
The study, which was part of the company's premarket approval application (PMA), found no significant differences in adverse events or survivorship between the two groups and patients experienced similar pain relief, improved function and range of motion.2 The FDA stated that the benefits of the DePuy CERAMAX System outweigh the risk of surgery when used on appropriate patients.3
1CeramTec. "BIOLOX® delta – Nanocomposite for Arthroplasty: The Fourth Generation of Ceramics." p. 4.
2DePuy Orthopaedics. DePuy CERAMAX Ceramic Total Hip System. "Information for Prescribers – Safety and Effectiveness Results."
3DA CDRH SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED). Page 41, Section C, Last sentence. Accessed 10/4/2011. http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070026b.pdf
Did You Know?
PINNACLE® is the only modular acetabular cup system that provides five bearing options in the U.S.
Use our downloadable PDFs to educate your patients on PINNACLE.
Considerations with Metal-on-Metal Technology
Clinical studies, laboratory testing, published literature and post-implantation monitoring show the potential benefits of metal-on-metal technology.
Clinical evidence and experience demonstrate that the PINNACLE® ULTAMET® Metal-on-Metal Articulation System successfully reduces pain and improves mobility in the vast majority of hip replacement patients and have survivorship rates that are consistent with or better than other metal-on-metal products. According to the Australian Orthopaedic Association National Joint Replacement Registry's 2010 Annual Report, more than 96 percent of PINNACLE ULTAMET metal-on-metal bearings were still in place at five years. To substantiate this finding, using data supplied for post-marketing surveillance by the National Joint Registry Centre in February 2011, DePuy performed a Kaplan-Meier survivorship analysis on 12,559 PINNACLE metal-on-metal bearings used in primary total hip replacement. The results showed a survivorship of 96.6 percent at five years, and 96.0 percent at seven years.1
Additional clinical evidence on the performance of the ULTAMET System can be found in the pre-market approval of the ceramic-on-metal, COMPLETE Hip System. These results were based in part on results from a two-year, randomized, multicenter, non-inferiority clinical study and laboratory testing, which found no clinical difference between 194 patients who received the new ceramic-on-metal system and 196 patients in a control group who received the ULTAMET System's metal-on-metal bearing.
1DePuy Performed Kaplan-Meier Survivorship Analysis based on data from the National Joint Registry for England and Wales. Data on file with DePuy.
Did You Know?
We continue to advance PINNACLE® bearing technology, design and materials.
Use our downloadable PDFs to educate your patients on PINNACLE.
Features & Benefits
A global leader in devices for joint replacement and trauma, DePuy worked with experienced orthopaedic surgeons, and leaders in the biomedical field to design and develop the PINNACLE® Acetabular Cup System.
The PINNACLE Cup System is designed with a wide range of bearing technologies. These modular solutions offer surgeons options, allowing them to meet the individual needs of each patient and his or her lifestyle.1
Advanced Modularity
The proprietary Variable Interface Prosthesis (VIP) taper technology contributes to the PINNACLE System's advanced modularity by supporting both polyethylene liners and hard bearing inserts. VIP taper technology also enables macro- and micro-stability by functioning as a supporting and locking mechanism.
Learn more about VIP Taper Technology
Advanced Tribology
The science behind DePuy's hip bearing surfaces – advanced tribology, or the study of friction and wear – allows for improved wear resistance.
Learn more about the DePuy products that reduce wear:
ASPHERE® M-Spec Contoured Metal Heads
Fixation Technologies
Learn about DePuy Orthopaedics' innovative coating and fixation technologies:
Learn more about our innovative coating technologies:
Clinically Proven POROCOAT® Porous Coating Optimized Fixation with GRIPTION® Coating DUOFIX® Enhanced Biological Fixation
Advanced Materials
The materials used in the PINNACLE Acetabular Cup System offer mechanical integrity, wear resistance and oxidative stability. DePuy's advanced modularity and range of solutions allow surgeons to match the right components to each patients' needs. This is a consideration more important than ever, considering today's patients are demanding far more from implants than previous generations.
1Australian Orthopaedic Association, Hip and Knee Arthroplasty, 2010 Annual Report.
Learn more about the many PINNACLE Cup System options available to patients
Did You Know?
Products in the PINNACLE® line were first cleared for sale by the U.S. FDA in 2000.
Use our downloadable PDFs to educate your patients on PINNACLE.
Clinical Data
Products in the PINNACLE® Acetabular Cup System line were first cleared for sale by the U.S. Food and Drug Administration under the 510K regulatory process in 2000. Since then, the PINNACLE Acetabular Cup System has been cleared for sale by regulators around the world.
The PINNACLE Cup System is backed by more than a decade's worth of clinical data that have consistently shown that PINNACLE is a safe and effective option for patients who are candidates for hip replacement.
Overall Performance
The safety and effectiveness of the PINNACLE Acetabular Cup System have been confirmed by clinical data.
•According to the National Joint Registry for England and Wales 2011 Annual Report, more than 97 percent of PINNACLE® Cup Systems, in combination with CORAIL® Hip System Stems, were still in place five years after they were implanted, exceeding the 5-year cementless total hip replacement survivorship rate of 96 percent across all hip replacement products and manufacturers. In the U.S., CORAIL is not approved for ceramic-on-ceramic or ceramic-on-metal bearings.
• According to the 2010 Australian Orthopaedic Association National Joint Replacement Registry annual report, PINNACLE Cup System survivorship at 5 years is greater than 96 percent when using various bearing combinations with CORAIL®, SUMMIT® and S-ROM® cementless hip stems.
• A multi-center clinical study conducted by leading orthopaedic surgeons showed that 96.1 percent of PINNACLE Cup Systems in the study were still in place eight years after surgery.1
With all of this clinical data, it is no surprise that based on joint replacement registry annual reports from 2011, the PINNACLE Cup System was the most implanted cementless cup in the United Kingdom and the second most-implanted cementless cup in Australia in 2009.
1 Multi-center PINNACLE Acetabular Cup System Outcomes Study. Kaplan-Meier survivorship results. Abstract submitted for 2011 American Association of Hip and Knee Surgeons Meeting.
Thank you for choosing the PINNACLE® Acetabular Cup System for your patient. Since its first implantation, the PINNACLE Cup System has been provided for nearly one million patients.