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Genesis 71243522

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03596010504159 UDI-DI Date29 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0305-05 FDA Unclassified (pre-2012) initiated 21 Jun 2004 on shared 510(k) K912735
    • Terminated Z-0304-05 FDA Unclassified (pre-2012) initiated 21 Jun 2004

    The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Genesis
Generic Name
Unicondylar knee insert
Model / Ref / Catalog
71243522
Description
GENISIS TIBIA POLY ONLAY EXTRA LARGE RIGHT MEDIAL/LEFT LATERAL 12MM
Primary DI / UDI-DI
03596010504159
510(k) Number
FDA Product Code
HSX
GMDN Term
Unicondylar knee insert
Device Class
Class II
Regulation Number
888.3520
GUDID distribution status
In Commercial Distribution

Related devices

Category: Unicondylar knee insert

Cleared under the same submission (K912735)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No