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Engage 1-10003-300

by Smith & Nephew, Inc.

Engage 1-10003-300 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K230653 on 4 May 2023 (1 earlier submission) and listed in FDA GUDID since 18 May 2022 (UDI-DI 00885556872963), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230653 Date4 May 2023DecidedStatusActive
United StatesGUDID listing Number00885556872963 UDI-DI Date18 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230653 decided 4 May 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00885556872963 listed 18 May 2022 Listed

Recalls

5 recalls · 5 ongoing · FDA

    • Ongoing Z-2621-2023 FDA Class II initiated 31 Aug 2023 on shared 510(k) K230653

    The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.

  • 4 recalls, same reason

    • Ongoing Z-1671-2023 FDA Class II initiated 2 May 2023
    • Ongoing Z-1670-2023 FDA Class II initiated 2 May 2023
    • Ongoing Z-1672-2023 FDA Class II initiated 2 May 2023
    • Ongoing Z-1673-2023 FDA Class II initiated 2 May 2023

    Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

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

Timeline

8 dated events

  1. Cleared FDA 510(k) K190439
  2. Listed FDA GUDID 00885556872963
  3. Recall initiated FDA recalls Z-1671-2023
  4. Recall initiated FDA recalls Z-1670-2023
  5. Recall initiated FDA recalls Z-1672-2023
  6. Recall initiated FDA recalls Z-1673-2023
  7. Cleared FDA 510(k) K230653
  8. Recall initiated FDA recalls Z-2621-2023

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Engage
Generic name
Unicondylar knee prosthesis
Model / Ref / Catalog
1-10003-300
Description
POROUS COATED FEMORAL COMP SIZE 3-RIGHT MEDIAL
Primary DI / UDI-DI
00885556872963
510(k) Number
FDA product code
HSX, NJD
GMDN term
Unicondylar knee prosthesis
Device class
Class II
Regulation number
888.3520, 888.3535
GUDID distribution status
In Commercial Distribution

Related devices

Category: Unicondylar knee prosthesis

Cleared under the same submission (K190439)

and 8 more cleared under K190439

Cleared under the same submission (K230653)

and 8 more cleared under K230653

Similar devices

Other devices filed under FDA product code HSX (PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, 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)