# K211548: POLARSTEM Calcar Reamer Guide

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 19, 2021 after 61 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: 7 generations back to K932481 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143739: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA, Smith & Nephew, Inc. (2015) Summary page 4.

## Indications for use
The POLARSTEM™ femoral stems with Ti/HA are 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: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. The POLARSTEM™ with Ti/HA is intended for single use only and is to be implanted without bone cement.

Source page: https://510kreport.com/device/K211548
Methodology: https://510kreport.com/methodology