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Taperloc Microplasty Femoral Components, Lateralized

by Biomet Manufacturing Corp

510(k) K062994

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK062994 Date9 Mar 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Lateralized Taperloc Microplasty Femoral Components
510(k) Number
FDA Product Code
KWA
Device Class
Class III
Regulation
21 CFR Part 888.3330
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Taperloc Microplasty Femoral Components, Lateralized are semi-constrained, uncemented metal hip prostheses designed for femoral use. These components feature a tapered design intended to enhance stability and integration within the femur, with a microporous surface to promote osseointegration.

These components are supplied as reusable surgical implants and are intended for use in orthopedic procedures under sterile conditions. They are classified as Class III devices under FDA regulations and have received Special 510(k) clearance. Multiple reference codes (e.g., 3020282716, 1047843) identify distinct sizes and variants, ensuring compatibility with specific surgical applications.

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