Barrett Unicondylar Tibial Bearing
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K011509 FDA 510(k)
- FDA Product Code
- HRY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3530 FDA 510(k)
- Regulation Number
- 888.3530 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Barrett Unicondylar Tibial Bearing is a prosthesis for the knee, specifically a femorotibial, semi-constrained, cemented metal/polymer component. It is designed to replace the tibial bearing surface in unicondylar knee arthroplasty.
This device is supplied non-sterile and is intended for single use. It is regulated under FDA 510(k) clearance K011509, with product code HRY and regulation number 888.3530, and is classified as a Class II medical device.
Frequently asked questions
What is the Barrett Unicondylar Tibial Bearing used for?
The Barrett Unicondylar Tibial Bearing is a prosthesis designed to replace the tibial bearing surface in unicondylar knee arthroplasty. It is a femorotibial, semi-constrained, cemented metal/polymer component intended to restore joint function in partial knee replacement procedures.
How is the Barrett Unicondylar Tibial Bearing supplied and is it sterile or single-use?
The device is supplied non-sterile and is intended for single use only. It must be sterilized by the user prior to implantation and should not be reused, as reuse could compromise device integrity and patient safety.
What regulatory pathway and identifiers apply to the Barrett Unicondylar Tibial Bearing?
The Barrett Unicondylar Tibial Bearing is regulated under FDA 510(k) clearance K011509, with product code HRY and regulation number 888.3530. It is classified as a Class II medical device and was found substantially equivalent to a predicate device.
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: BARRETT UNICONDYLAR TIBIAL BEARING (K011509) - FDA 510 (k), BARRETT UNICONDYLAR TIBIAL BEARING (K011509) — FDA 510 (k) | Innolitics, BARRETT UNICONDYLAR TIBIAL BEARING 510(k) K011509 - FDA.report, PDF K011509 - Barrett Unicondylar Tibial Bearing
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011509 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K011509 24 fields · synced Sep 26, 2026