Kennedy Tibial Component
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K831513 FDA 510(k)
- FDA Product Code
- HSX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3520 FDA 510(k)
- Regulation Number
- 888.3520 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Kennedy Tibial Component is an orthopedic device intended for use in knee arthroplasty procedures. It is a tibial implant designed to replace the proximal tibial surface in total knee replacement systems.
This device is supplied non-sterile and is intended for single use. It received FDA 510(k) clearance K831513 on July 28, 1983, under product code HSX, and is manufactured by Biomet, Inc. in McHenry, Illinois, United States.
Frequently asked questions
What is the Kennedy Tibial Component intended for?
The Kennedy Tibial Component is an orthopedic device intended for use in knee arthroplasty procedures, specifically designed to replace the proximal tibial surface in total knee replacement systems.
How is the Kennedy Tibial Component supplied and is it reusable?
The device is supplied non-sterile and is intended for single use only, meaning it should not be reprocessed or reused after implantation.
What regulatory pathway was used for the Kennedy Tibial Component and when was it cleared?
The Kennedy Tibial Component received FDA 510(k) clearance under submission K831513 on July 28, 1983, based on a determination of substantial equivalence to a predicate device.
Who manufactures the Kennedy Tibial Component and where is it produced?
The Kennedy Tibial Component is manufactured by Biomet, Inc. at their facility located in McHenry, Illinois, United States.
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: KENNEDY TIBIAL COMPONENT (K831513) - FDA 510 (k), KENNEDY TIBIAL COMPONENT (K831513) — FDA 510 (k) | Innolitics, PDF K831513 - Kennedy Tibial Component, Kennedy Tibial Component 510 (k) K831513 - FDA.report, Persona® OsseoTi® Keel Tibia - Zimmer Biomet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831513 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K831513 24 fields · synced Sep 19, 2026