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Genesis II E0014966-1

by Smith & Nephew, Inc.

Active United States. Also listed in GUDID (US).

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

510(k) K121393

FDA submission, from GUDID

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 Number00885556647820 UDI-DI Date25 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121393 Date7 Aug 2012DecidedStatusActive

Official records

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-0878-2020 FDA Class II initiated 16 Dec 2019

    Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

    • Terminated Z-0200-2019 FDA Class II initiated 18 Sep 2018

    One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

    • Terminated Z-2163-2018 FDA Class II initiated 4 May 2018

    One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

    • Terminated Z-1902-2018 FDA Class II initiated 9 Apr 2018

    A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.

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  • Withdrawn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
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
E0014966-1
Description
SIZE 3 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
Primary DI / UDI-DI
00885556647820
510(k) Number
FDA product code
MBH
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class II
Regulation number
888.3565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K121393)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No