# K082239: Depuy C-Stem Amt

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 29, 2008 after 22 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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). 26 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042959: Depuy C-Stem Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2004) Summary page 1.

## Most influential descendants
- K220216: C-Stem AMT LE Prosthesis (2022), 8 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
- K152530: UCP Stem (2016), 2 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

## Indications for use
The DePuy C-Stem AMT is indicated for cemented use in the treatment of: 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, 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 surgery, including joint reconstruction, internal fixation, arthrodesis, herniarthroplasty, surface replacement arthoplasty, or other total hip replacement; and 5. Certain cases of ankylosis.

Source page: https://510kreport.com/device/K082239
Methodology: https://510kreport.com/methodology