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Catalystem 71314020

by Smith & Nephew, Inc.

Catalystem 71314020 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K240381 on 27 Jun 2024 and listed in FDA GUDID since 23 Aug 2024 (UDI-DI 00885556891568), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K240381

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 Number00885556891568 UDI-DI Date23 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240381 Date27 Jun 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240381 decided 27 Jun 2024 Active
  • FDA GUDID UDI-DI 00885556891568 listed 23 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240381
  2. Listed FDA GUDID 00885556891568

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Catalystem
Generic name
Coated hip femur prosthesis, modular
Model / Ref / Catalog
71314020
Primary DI / UDI-DI
00885556891568
FDA product code
MEH, LPH, LZO
GMDN term
Coated hip femur prosthesis, modular
Device class
Class II
Regulation number
888.3353, 888.3358
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Coated hip femur prosthesis, modular

Cleared under the same submission (K240381)

and 8 more cleared under K240381

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)