# K220216: C-Stem AMT LE Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Jul 22, 2022 after 177 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: 7 generations back to K935452 (1994). 27 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 36 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 4.
- K082239: Depuy C-Stem Amt, DePuy Orthopaedics, Inc. (2008) Summary page 4.
- K982918: Depuy C-Stem System, DePuy Orthopaedics, Inc. (1998) 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
- K254043: TRIVANCE™ Hip Stem (2026), 0 descendants of its own

## Indications for use
Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint 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 hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The C-Stem AMT LE Hip Prosthesis is indicated for cemented use only.

Source page: https://510kreport.com/device/K220216
Methodology: https://510kreport.com/methodology