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Revision Knee System

by Smith & Nephew, Inc.

510(k) K041106

Revision Knee System is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K041106 on 1 Jul 2004, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK041106 Date1 Jul 2004ClearedStatusActive

Official records

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

2 dated events

  1. Cleared FDA 510(k) K041106
  2. 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  • Withdrawn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

510(k)

510(k) Number
FDA product code
JWH
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K041106

81 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K041106
UDI-DISize and differences
GENESIS II 71930903
Smith & Nephew, Inc.
71930903 / 7193090300885556052891 —No longer on the market
LEGION 71421654
Smith & Nephew, Inc.
71421654 / 7142165403596010544360 —On the market
LEGION 71421656
Smith & Nephew, Inc.
71421656 / 7142165603596010544384 —On the market
LEGION 71421658
Smith & Nephew, Inc.
71421658 / 7142165803596010544407 —On the market
LEGION 71421659
Smith & Nephew, Inc.
71421659 / 7142165903596010544414 —On the market
LEGION 71421662
Smith & Nephew, Inc.
71421662 / 7142166203596010544438 —On the market
LEGION 71421663
Smith & Nephew, Inc.
71421663 / 7142166303596010544445 —On the market
LEGION 71421665
Smith & Nephew, Inc.
71421665 / 7142166503596010544469 —On the market
LEGION 71421666
Smith & Nephew, Inc.
71421666 / 7142166603596010544476 —On the market
LEGION 71421667
Smith & Nephew, Inc.
71421667 / 7142166703596010544483 —On the market
LEGION 71421668
Smith & Nephew, Inc.
71421668 / 7142166803596010544490 —On the market
LEGION 71421669
Smith & Nephew, Inc.
71421669 / 7142166903596010544506 —On the market
LEGION 71421672
Smith & Nephew, Inc.
71421672 / 7142167203596010551924 —On the market
LEGION 71421673
Smith & Nephew, Inc.
71421673 / 7142167303596010551931 —On the market
LEGION 71421674
Smith & Nephew, Inc.
71421674 / 7142167403596010551948 —On the market
LEGION 71421676
Smith & Nephew, Inc.
71421676 / 7142167603596010551962 —On the market
LEGION 71421711
Smith & Nephew, Inc.
71421711 / 7142171103596010544964 —On the market
LEGION 71421713
Smith & Nephew, Inc.
71421713 / 7142171303596010544971 —On the market
LEGION 71421715
Smith & Nephew, Inc.
71421715 / 7142171503596010544988 —On the market
LEGION 71421724
Smith & Nephew, Inc.
71421724 / 7142172403596010545022 —On the market
LEGION 71421726
Smith & Nephew, Inc.
71421726 / 7142172603596010545046 —On the market
LEGION 71421731
Smith & Nephew, Inc.
71421731 / 7142173103596010545053 —On the market
LEGION 71421732
Smith & Nephew, Inc.
71421732 / 7142173203596010545060 —On the market
LEGION 71421735
Smith & Nephew, Inc.
71421735 / 7142173503596010545091 —On the market
LEGION 71421736
Smith & Nephew, Inc.
71421736 / 7142173603596010545107 —On the market
LEGION 71421741
Smith & Nephew, Inc.
71421741 / 7142174103596010545114 —On the market
LEGION 71421743
Smith & Nephew, Inc.
71421743 / 7142174303596010545138 —On the market
LEGION 71421745
Smith & Nephew, Inc.
71421745 / 7142174503596010545152 —On the market
LEGION 71421746
Smith & Nephew, Inc.
71421746 / 7142174603596010545169 —On the market
LEGION 71421753
Smith & Nephew, Inc.
71421753 / 7142175303596010545190 —On the market
LEGION 71421754
Smith & Nephew, Inc.
71421754 / 7142175403596010545206 —On the market
LEGION 71421756
Smith & Nephew, Inc.
71421756 / 7142175603596010545220 —On the market
LEGION 71421762
Smith & Nephew, Inc.
71421762 / 7142176203596010545244 —On the market
LEGION 71421764
Smith & Nephew, Inc.
71421764 / 7142176403596010545268 —On the market
LEGION 71421771
Smith & Nephew, Inc.
71421771 / 7142177103596010545299 —On the market
LEGION 71421774
Smith & Nephew, Inc.
71421774 / 7142177403596010545329 —On the market
LEGION 71421775
Smith & Nephew, Inc.
71421775 / 7142177503596010545336 —On the market
LEGION 71421776
Smith & Nephew, Inc.
71421776 / 7142177603596010545343 —On the market
LEGION 71421802
Smith & Nephew, Inc.
71421802 / 7142180203596010545367 —On the market
LEGION 71421803
Smith & Nephew, Inc.
71421803 / 7142180303596010545374 —On the market
LEGION 71421804
Smith & Nephew, Inc.
71421804 / 7142180403596010545381 —On the market
LEGION 71421805
Smith & Nephew, Inc.
71421805 / 7142180503596010545398 —On the market
LEGION 71421806
Smith & Nephew, Inc.
71421806 / 7142180603596010545404 —On the market
LEGION 71421807
Smith & Nephew, Inc.
71421807 / 7142180703596010545411 —On the market
LEGION 71421827
Smith & Nephew, Inc.
71421827 / 7142182703596010545435 —On the market
LEGION 71933561
Smith & Nephew, Inc.
71933561 / 7193356100885556062449 —On the market
LEGION 71933562
Smith & Nephew, Inc.
71933562 / 7193356200885556062982 —On the market
LEGION 71933564
Smith & Nephew, Inc.
71933564 / 7193356400885556061787 —On the market
LEGION 71933565
Smith & Nephew, Inc.
71933565 / 7193356500885556062142 —On the market
LEGION 71933566
Smith & Nephew, Inc.
71933566 / 7193356600885556062661 —On the market

Similar devices

Other devices filed under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

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