# K231448: TANDEM Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 19, 2023 after 62 days
- Product code: LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 178 ancestors in all.
No later device cites it as a predicate yet.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896580: Uni-Polar Head, Richards Medical Co., Inc. (1990) Summary page 4.
- K023743: Smith & Nephew Global Bipolar System, Smith & Nephew, Inc. (2003) Summary page 4.
- K211176: Smith & Nephew Hip Systems, Smith & Nephew, Inc. (2022) Summary page 4.

## Recalls of this device
- Oct 15, 2024 · Class II · Z-0326-2025: The Bipolar assembly contains an oversized Retainer Ring.

## Indications for use
The Smith & Nephew TANDEM Unipolar and Bipolar Hip System is intended for partial hip arthroplasty in skeletally mature patients. It is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture. The TANDEM Unipolar and Bipolar head components are intended to articulate against the natural acetabulum, which requires no use of bone cement.

Source page: https://510kreport.com/device/K231448
Methodology: https://510kreport.com/methodology