Skip to content

Tandem 126646

by Smith & Nephew, Inc.

Tandem 126646 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K231448 on 19 Jul 2023 (2 earlier submissions) and listed in FDA GUDID since 25 Aug 2015 (UDI-DI 03596010079756), 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

1 ongoing

Recall on shared 510(k) K211176; other models may be affected

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 NumberK231448 Date19 Jul 2023DecidedStatusActive
United StatesGUDID listing Number03596010079756 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231448 decided 19 Jul 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 03596010079756 listed 25 Aug 2015 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0326-2025 FDA Class II initiated 15 Oct 2024 on shared 510(k) K211176

    The Bipolar assembly contains an oversized Retainer Ring.

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K896580
  2. Listed FDA GUDID 03596010079756
  3. Cleared FDA 510(k) K211176
  4. Cleared FDA 510(k) K231448
  5. Recall initiated FDA recalls Z-0326-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tandem
Generic name
Metallic femoral head prosthesis
Model / Ref / Catalog
126646
Primary DI / UDI-DI
03596010079756
510(k) Number
FDA product code
LZY
GMDN term
Metallic femoral head prosthesis
Device class
Class II
Regulation number
888.3360
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Metallic femoral head prosthesis

Cleared under the same submission (K211176)

and 8 more cleared under K211176

Cleared under the same submission (K231448)

and 8 more cleared under K231448

Similar devices in this category

Other devices filed under Metallic femoral head prosthesis.

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)