Now that second quarter orthopedic sales results are in, we thought we’d bring you the second quarter Premarket Approvals (PMA) Original and Supplemental Approvals from the FDA.
Second Quarter FDA Ortho Approvals
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Secondary
The FDA approved 6 Original PMAs during the quarter while granting 315 positive Supplemental Approvals during the quarter. None of the Original PMAs were related to orthopedic devices.
Original PMA decision times (receipt to decision) increased from 113.2 days in in April to 221.8 days in June. The FDA portion of that decision time went from 92.7 days in April to 188.6 days in June.
April 2012
Four Non-Orthopedic Related Original (PMA) Approvals:
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Bond Oracle Her2 IHC System for Leica Biosystems Newcastle Upon Tyne, United Kingdom
Presillion plus CoCr Coronary Stent on RX System for Medinol Ltd. Tel-Aviv, Israel
Architect HBsAg Qualitative Calibrators and Controls for Abbott Laboratories Abbott Park, Illinois
Epic Vascular Self-Expanding Stent System for Boston Scientific Corporation Maple Grove, Minnesota
Orthopedic-Related Supplemental Approvals:
Exactech, Inc., Gainesville, Florida
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Novation Ceramic Articulation Hip System (AHS)
Approval for use of an additional package sealer for the acetabular liner and femoral head sterile barrier packaging processes
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Novation Ceramic AHS Articulation Hip System
Approval for changes to the Novation AHS Instructions for Use to reorganize information for clarity, remove information that is redundant, and ensure consistency
DePuy Orthopaedics, Inc., Warsaw, Indiana
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DePuy Pinnacle CoMplete Acetabular Hip System
Approval for the addition of the Trilock BPS (Bone Preserving Hip Stem) to the list of compatible femoral stem components. The device, as modified, will be marketed under the trade name DePuy Pinnacle CoMplete Acetabular Hip System and is indicated as a single use device intended for uncemented fixation. The device is intended as a primary joint replacement prosthesis in total hip arthroplasty for skeletally mature patients suffering at least moderate pain in the hip joint from non-inflammatory degenerative joint disease (NIDJD) and its composite diagnoses of osteoarthritis (OA) or post-traumatic arthritis. The device’s inserts (Pinnacle Ultamet) are only intended for use with DePuy’s femoral and acetabular components having matching outer and inner diameters.
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Duraloc Option Ceramic Hip System
Changes to the sterile barrier package sealing process used for the ceramic femoral heads and acetabular liners
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Ceramax Total Hip System
Changes to the sterile barrier package sealing process used for the ceramic femoral heads and acetabular liners
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CoMplete Acetabular Hip System
Changes to the sterile barrier package sealing process used for the ceramic femoral heads and acetabular liners
May 2012
No PMA Approvals
Orthopedic-Related Supplemental Approvals
Integra LifeSciences Corporation, Plainsboro Township, New Jersey
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Integra Artificial Skin, Dermal Regeneration Template, Integra Dermal Regeneration Template – Terminally Sterilized (IDRT-ts)
Approval for a manufacturing site located at Integra Neurosciences in Anasco, Puerto Rico
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Integra Dermal Regeneration Template – Terminally Sterilized (IDRT-ts)
Approval for a manufacturing site located at Synergy Health AST, LLC in Denver, Colorado
Genzyme Corporation, Cambridge, Massachusetts
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Synvisc and Synvisc-One
Approval for the addition of a new product data and laboratory information management system
June 2012
Two Non-Orthopedic Related Original (PMA) Approvals:
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Glaukos iStent Trabecular Micro-Bypass Stent (Models: GTS-100R, GTS-100L) and inserter (GTS-l00i). Glaukos Corporation, Laguna Hills, California
Access Hybritech p2PSA on the Access Immunoassay Systems. Beckman Coulter, Inc., Chaska, Minnesota
Orthopedic-Related Supplemental Approvals
Smith & Nephew, Inc., Memphis and Cordova, Tennessee
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Reflection Ceramic Hip System
Approval for addition of an alternate site for the machining processes for R3 Acetabular Shells
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Exogen 4000+ Ultrasound Bone Healing System
Change in supplier
DePuy Orthopaedics, Inc., Warsaw, Indiana
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Duraloc Ceramic Hip
Approval of the post-approval study protocol
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Duraloc Option Ceramic Hip System
Changes to the device sterile packaging
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Ceramax Ceramic Total Hip System
Changes to the device sterile packaging
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Pinnacle CoMplete Ceramic-on-Metal Acetabular Hip System
Changes to the device sterile packaging
Medtronic Sofamor Danek, Memphis, Tennessee
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Infuse Bone Graft
Approval for the proposed labeling revisions related to the appearance of the reconstituted product and warning statement about use in patients suspected of having cancer at the product application site
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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