# K161226: Revision Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Feb 10, 2017 after 284 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: 8 generations back to K921308 (1994). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151739: Revision Femoral Stem, Lima Corporate S.P.A. (2015) Summary page 5.

## Indications for use
Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

Source page: https://510kreport.com/device/K161226
Methodology: https://510kreport.com/methodology