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Genesis II 71930903

by Smith & Nephew, Inc.

Genesis II 71930903 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K041106 on 1 Jul 2004 and listed in FDA GUDID since 28 Sep 2015 (UDI-DI 00885556052891), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K041106

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556052891 UDI-DI Date28 Sep 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK041106 Date1 Jul 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041106 decided 1 Jul 2004 Active
  • FDA GUDID UDI-DI 00885556052891 listed 28 Sep 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0092-2018 FDA Class II initiated 14 Sep 2017

    The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

Timeline

3 dated events

  1. Cleared FDA 510(k) K041106
  2. Listed FDA GUDID 00885556052891
  3. Recall initiated FDA recalls Z-0092-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Genesis II
Generic name
Knee arthroplasty wedge
Model / Ref / Catalog
71930903
Description
GEN II OXINIUM DISTAL FEM WEDGE SZ 6 10 X 10MM
Primary DI / UDI-DI
00885556052891
510(k) Number
FDA product code
JWH
GMDN term
Knee arthroplasty wedge
Device class
Class II
Regulation number
888.3560
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K041106)

and 8 more cleared under K041106

Similar devices

Other devices filed under FDA product code JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER).

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)