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Repicci Ii Unicondylar Knee All Poly Tibial Components

FDA 510(k)

Class II (US FDA 510(k))

510(k) K980665

by Biomet, Inc.

Identifiers

510(k) Number
K980665 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)

This device is a Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, specifically a unicondylar knee all-polyethylene tibial component. It is designed for partial knee replacement and features a universal-geometry polyethylene tibial component with a waffle pattern and recessed holes on the undersurface to facilitate fixation with bone cement.

The device is supplied as a single-use orthopedic implant. It is indicated for use in orthopedic procedures and has received FDA 510(k) clearance (K980665) as a Class II device under regulation number 888.3530, with a traditional clearance pathway and substantially equivalent decision. It is manufactured by Biomet, Inc. and is intended for cemented fixation in partial knee arthroplasty.

Frequently asked questions

What is the REPICCI II Unicompartmental Knee All-Poly Tibial Component used for?

It is designed for partial knee replacement, specifically as a unicondylar knee all-polyethylene tibial component intended for cemented fixation in orthopedic procedures to replace the tibial surface in femorotibial joints.

How is the REPICCI II tibial component supplied and is it reusable?

The device is supplied as a single-use orthopedic implant, meaning it is intended for one-time implantation and should not be reprocessed or reused after removal from its sterile packaging.

What design features does the REPICCI II tibial component have to aid fixation?

It features a universal-geometry polyethylene tibial component with a waffle pattern and recessed holes on the undersurface, which are designed to enhance cement fixation by increasing surface area and mechanical interlock.

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: Repicci Ii Unicondylar Knee All Poly Tibial Components, K980665 FDA 510(k) - REPICCI II UNICONDYLAR KNEE ALL POLY TI..., Repicci Ii Unicondylar Knee All Poly Tibial Components

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K980665 24 fields · synced Sep 27, 2026