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Howmedica Kinematic II Modular Tibial Component

by Howmedica Corp. 510(k)

Active United States

510(k) K871349

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871349 Date1 Sep 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a prosthesis for the knee, specifically a patellofemorotibial, semi-constrained, cemented implant made of polymer/metal/polymer materials. It is classified under product code JWH as a Class II medical device requiring special controls.

It received FDA 510(k) clearance (K871349) from Howmedica Corp. on September 1, 1987, following a traditional review process. The device is substantially equivalent to a predicate and was submitted by Howmedica Corp. located in Rutherford, New Jersey.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT used for?

    It is a prosthesis for the knee, specifically designed as a patellofemorotibial, semi-constrained, cemented implant to replace damaged tibial components in knee joint reconstruction.

  • How is the HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT supplied and what materials is it made of?

    The device is supplied as a cemented implant constructed from polymer/metal/polymer materials, intended for surgical implantation in knee procedures requiring tibial component replacement.

  • What regulatory pathway was used for the HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT and when was it cleared?

    It received FDA 510(k) clearance through a traditional review process on September 1, 1987, under K871349, demonstrating substantial equivalence to a predicate device.