# K251292: RECLAIM Monobloc Revision Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Depuy Ireland UC
- Decided: May 23, 2025 after 28 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: 19 generations back to K941847 (1994). 287 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221462: DePuy Reclaim Monobloc Revision Femoral Stem, Depuy Ireland UC (2022) Summary page 5.
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional, Depuy Ireland UC (2024) Summary page 5.

## Most influential descendants
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own

## Indications for use
The DePuy RECLAIM Monobloc Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

Source page: https://510kreport.com/device/K251292
Methodology: https://510kreport.com/methodology