# K093736: Depuy Corail Hip System, Revision Stem

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 10, 2011 after 461 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 K935452 (1994). 17 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 2.
- K961732: KAR, Landos, Inc. (1997) Summary page 2.

## Most influential descendants
- K192946: DePuy Corail AMT Hip Prosthesis (2019), 10 descendants of its own
- K211657: EMPHASYS Femoral Stems (2021), 7 descendants of its own
- 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
- K203167: DePuy Corail AMT Hip Prosthesis (2020), 2 descendants of its own
- K171249: Entrada™ hip stem (2017), 2 descendants of its own

## Indications for use
The DePuy Corail Revision Stem is indicated for cementless use in the treatment of: 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis, or congenital hip dysplasia; 2. Avascular necrosis of the femoral head; 3. Acute traumatic fracture of the femoral head or neck; 4. Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and 5. Certain cases of ankylosis.

Source page: https://510kreport.com/device/K093736
Methodology: https://510kreport.com/methodology