TANDEM Hip System

• • Ongoing Z-0326-2025 FDA Class II ·initiated 15 Oct 2024 ·on shared 510(k) K231448

  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.

1. 19 Jul 2023 Cleared FDA 510(k) K231448
2. 15 Oct 2024 Recall initiated FDA recalls Z-0326-2025

510(k) Number

K231448 ↗

FDA product code

LZY

Device class

Class II

Regulation

21 CFR Part 888.3360

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

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

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

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.

Other devices filed under FDA product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball).

• Taperloc® Microplasty® 33-103212 by Biomet Orthopedics, Inc.
• Taperloc® Microplasty® 33-103208 by Biomet Orthopedics, Inc.
• FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR by Protek, Inc.
• ENDO HEAD by Medacta International
• 1363-10-000 136310000 by DEPUY ORTHOPAEDICS, INC.
• 1363-12-000 136312000 by DEPUY ORTHOPAEDICS, INC.
• Modular Cathcart Fracture System by Depuy, Inc.
• IONGUARD TITANIUM MODULAR HEADS by Biomet, Inc.
• UNI-POLAR HEAD by Richards Medical Co., Inc.
• BHR BIPOLAR FEMORAL HEAD COMPONENT by Implantology Corp.

• Real Intelligence ROB30801

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• Real Intelligence ROB30007

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-01

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-04

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

See all devices from Smith & Nephew, Inc. →