# K982918: Depuy C-Stem System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Oct 5, 1998 after 47 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: 3 generations back to K891454 (1989). 10 ancestors in all.
25 later devices descend from it; 5 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)
- K960658: Collarless Polished Taper Hip Prosthesis, Zimmer, Inc. (1996) Summary page 1.
- K974054: Distal Centralizer, Exeter II Hip System, Howmedica, Inc. (1997) Summary page 1.
- K980843: Exeter Intramedullary Bone Plug, Howmedica, Inc. (1998) Summary page 1.
- K802627: Ortron 90* Hip Prosthesis, Cintor Orthopaedic Div. (1980) Summary page 1.
- K871867: Elite Modular Hip System, Thackray USA (1988) Summary page 1.
- K943727: Biostop G Bone Cement Restrictor, Landos, Inc. (1995) Summary page 1.
- K951930: Cementralizer Distal Stem Centralizer, Depuy, Inc. (1995) Summary page 1.

## Most influential descendants
- K042959: Depuy C-Stem Amt Hip Prosthesis (2004), 23 descendants of its own
- K082239: Depuy C-Stem Amt (2008), 14 descendants of its own
- K013350: Modification to Depuy C-Stem System (2001), 14 descendants of its own
- K220216: C-Stem AMT LE Prosthesis (2022), 8 descendants of its own
- K152084: Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug (2016), 7 descendants of its own

## Indications for use
The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient with a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or theumnatoid arthritis: avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.

Source page: https://510kreport.com/device/K982918
Methodology: https://510kreport.com/methodology