Highly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri-Peg Patel…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113756 FDA 510(k)
- FDA Product Code
- OIY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Prosthesis, Knee, Patellofemoral, Semi-Constrained, Cemented, combining polymer, metal, and additive materials. It features highly cross-linked polyethylene infused with vitamin E (VE) to enhance durability and reduce wear, available in central peg, tri-peg, and metal-backed configurations. The patella component is designed to articulate with femoral and tibial implants in total knee arthroplasty, providing stability and load distribution in the patellofemoral joint.
The components are supplied as reusable surgical implants, intended for cemented fixation during knee replacement procedures. Each variant (central peg, tri-peg, or metal-backed) is individually packaged and sterilized for single-use per procedure. The device complies with FDA 510(k) clearance (K113756) under Special Review in the Orthopedic category, with regulatory classification as Class II. Storage requires adherence to manufacturer guidelines for sterile packaging integrity and shelf-life compliance.
Frequently asked questions
What is the purpose of the highly cross-linked VE material in this patella prosthesis?
The highly cross-linked polyethylene infused with vitamin E (VE) is designed to enhance the durability and longevity of the patella component. This material reduces wear and oxidation, which helps maintain joint function and reduces the risk of complications over time, making it ideal for long-term knee replacement procedures.
Are these patella implants reusable or intended for single-use?
These patella implants are intended for single-use per procedure. Each variant—central peg, tri-peg, or metal-backed—is individually packaged and sterilized, ensuring sterility and compliance with surgical best practices for knee arthroplasty.
What configurations are available for the patella component?
The patella component is available in three configurations: central peg, tri-peg, and metal-backed. These designs cater to different surgical needs, offering varying levels of stability and articulation with femoral and tibial implants in total knee arthroplasty.
How should these implants be stored to maintain sterility?
Storage must adhere strictly to the manufacturer’s guidelines to preserve sterile packaging integrity and shelf-life compliance. This includes keeping the implants in their original, unopened packaging, away from moisture, extreme temperatures, and direct sunlight, to ensure they remain sterile and functional until use.
What type of fixation is used for these patella implants?
These patella implants are designed for cemented fixation, meaning they are secured to the bone using orthopedic cement during surgery. This method provides a stable and durable attachment, ensuring proper alignment and function of the knee joint post-implantation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Highly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri ..., 510 (k) K113756 — HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY ..., PDF K113756 - Highly Cross Linked Ve Central Peg Patella Highly Cross ..., Device Listing 1276445272 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113756 | Class II | Active |
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Manufacturer
- Manufacturer
- Encore Medical L.P.
Sources (1)
- FDA 510(k) K113756 24 fields · synced Oct 1, 2026