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Metafix Femoral Stem for Hemi-Arthroplasty

by Corin USA

510(k) K120362

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 · Traditional NumberK120362 Date4 May 2012ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Metafix Femoral Stem for Hemiarthroplasty is an orthopedic device intended for use in hip hemiarthroplasty procedures. It is designed to replace the femoral component of the hip joint in patients requiring partial joint replacement.

This device is supplied non-sterile and is intended for single use. It is manufactured by Corin USA and received FDA 510(k) clearance (K120362) on May 4, 2012, under product code LZO, with a determination of substantial equivalence to a predicate device.

Other devices from Corin USA

See all devices from Corin USA →

Questions

AI-generated answers, 23 Sep 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 Metafix Femoral Stem for Hemiarthroplasty used for?

    The Metafix Femoral Stem for Hemiarthroplasty is intended to replace the femoral component of the hip joint in patients undergoing hip hemiarthroplasty procedures, which involve partial joint replacement of the hip.

  • How is the Metafix Femoral Stem supplied and is it reusable?

    The device is supplied non-sterile and is designed for single use only, meaning it must not be reprocessed or reused after implantation to ensure patient safety and device integrity.

  • Who manufactures the Metafix Femoral Stem and when was it cleared?

    The Metafix Femoral Stem for Hemiarthroplasty is manufactured by Corin USA and received FDA 510(k) clearance (K120362) on May 4, 2012, based on a determination of substantial equivalence to a predicate device.