Recap: FDA Clearances Focus on Joint Replacement Improvements

In the second half of the year, these companies announced FDA clearance and launch of shoulder, hip and knee replacement enhancements, as well as the premarket approval of a system that helps surgeons plan for personalized ankle arthroscopy.

Shoulder

LimaCorporate | PRIMA TT Glenoid, K222427
Submitted August 2022, granted October 2022
Primary predicate: LimaCorporate SMR Reverse Liner, K220792
About the product:

• Indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy. The glenoid baseplate is designed for uncemented use with the addition of screw fixation.
• The baseplate and the humeral stem are 3D-printed, and the system features Lima’s Trabecular Titanium technology to support strong primary fixation and secondary bone ingrowth.
• Designed to offer a complete solution suitable for a wide range of glenoid replacement cases in reverse shoulder arthroplasty. Surgeons can easily move between baseplate designs to address different pathologies, from simple primary procedures to complex clinical cases.

Zimmer Biomet Identity Shoulder

Zimmer Biomet | Identity Shoulder System, K213856
Submitted December 2021, granted September 2022
Primary predicate: Biomet Comprehensive Shoulder System, K193038
About the product:

• Convertible system intended for anatomic, reverse and revision shoulder replacement.
• Expands on traditional inlay and onlay reconstruction used in reverse shoulder replacement by providing eight humeral tray combinations that give surgeons increased options for aligning the humerus with the glenoid, without lengthening the arm.
• Designed to offer adaptability for potential revision procedures, the Identity Shoulder System allows for 5mm of additional joint space below resection, which gives surgeons more anatomy to work with if a revision is needed in the future.

Hip

Conformis Actera Stem Collar

Conformis | Actera Hip System, K221104
Submitted April 2022, granted August 2022
Primary predicate: DePuy Orthopaedics ACTIS Duofix Hip Prosthesis, K210581
About the product:

• An uncemented, total hip replacement system comprising femoral and acetabular components. All implanted components are provided sterile. X-ray, acetate or digital templates are included for determining implant sizes and component placement. Non-sterile reusable instruments are provided.
• Actera adds a tri-taper femoral stem design to the Conformis hip portfolio. This device is intended to facilitate a minimally invasive approach similar to the direct anterior technique, with easier access to the femur and consequently less injury to muscles and fewer interactions with nerves.

Knee

Exactech (filed under Signature Orthopaedics) | TriVerse Total Knee Replacement, K222380
Submitted August 2022, granted October 2022
Primary predicate: Biomet Vanguard Complete Knee System, K113550
About the product:

• A modular total knee comprising a femoral component, meniscal inserts, a locking bar for the meniscal insert, and a patella and a tibial baseplate with a tibial post and bolt.
• TriVerse is designed to accommodate surgical efficiency in hospitals and surgery centers, offering cruciate retaining, anterior stabilized and posterior stabilized constructs. Additionally, the TriVerse insert bearings will be exclusively available in highly crosslinked vitamin E-stabilized polyethylene.
• TriVerse will launch with a compact set of adjustable mechanical instrumentation, with future compatibility planned with the company’s ExactechGPS system.

Zimmer Biomet Persona OsseoTi Keel Tibia

Zimmer Biomet | Persona OsseoTi Keel Tibia , K221479
Submitted May 2022, granted November 2022
Primary predicate: Zimmer Persona Knee, K113369
About the product:

• The purpose of this submission is to add three new components to Zimmer Biomet’s Persona Personalized Knee System: a nonporous cemented stemmed tibial baseplate, a porous OsseoTi non-cemented tibial baseplate and a porous plasma sprayed femur.
• The Persona OsseoTi Keel Tibia features a new porous version of the Persona anatomic tibia with Zimmer Biomet’s OsseoTi Porous Metal Technology, which employs anatomical data and 3D-printing technology to build a structure that mimics the architecture of human cancellous bone. This material is combined with a keeled design to deliver stable initial and biological fixation.
• A new cemented implant option complements the Persona OsseoTi Keel Tibia to provide surgeons with fixation versatility during procedures.

Ankle

Enovis STAR Ankle

Enovis (filed under DJO Global) | STAR Patient Specific Instrumentation (PSI) System, PMA P050050
Submitted April 2022, granted November 2022
About the product:

• This is a premarket approval supplement to the original Scandinavian Total Ankle Replacement System (STAR Ankle), PMA P050050. The supplement adds approval for the patient-specific instrumentation and a new manufacturing facility at Medical Modeling, a 3D Systems company.
• STAR PSI provides a personalized pre-operative plan for individual patients. Surgeons receive and review a 3D visualization of the patient’s ankle joint, including information about existing implants or bone defects, to plan for the total ankle replacement.
• The product entered FDA’s Early Product Surveillance in December and could fully launch by the end of March 2023.

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