Skip to content

Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component

by Smith & Nephew Richards, Inc.

510(k) K962557

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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)SN Traditional NumberK962557 Date5 Dec 1996DecidedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0281-2025 FDA Class II initiated 2 Oct 2024

    Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

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  • Withdrawn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
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SN

Other devices from Smith & Nephew Richards, Inc.

See all devices from Smith & Nephew Richards, Inc. →