# K221462: DePuy Reclaim Monobloc Revision Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Oct 21, 2022 after 155 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 K935452 (1994). 33 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102080: Depuy Reclaim Revision Hip System, Depuy (Ireland) (2010) Summary page 4.

## Most influential descendants
- 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 (2024), 5 descendants of its own
- K251292: RECLAIM Monobloc Revision Femoral Stem (2025), 1 descendant of its own
- K243977: EMPHASYS Acetabular System (2025), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K252067: Velora Acetabular System (2025), 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/K221462
Methodology: https://510kreport.com/methodology