# K203175: POLARSTEM Cemented Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 22, 2021 after 269 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K932481 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130728: Polarstem Standard and Lateral Femoral Stems with TI/HA, Smith & Nephew, Inc. (2013) Summary page 4.

## Indications for use
The POLARSTEM Cemented Femoral Stem is indicated for advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head; failure of previous hip surgery, such as joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. The POLARSTEM Cemented Femoral Stem is intended for single use only and is to be implanted with bone cement.

Source page: https://510kreport.com/device/K203175
Methodology: https://510kreport.com/methodology