# K013352: Summit Cemented Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 17, 2001 after 69 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: 1 generation back to K900638 (1990). 3 ancestors in all.
36 later devices descend from it; 6 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)
- K942370: Depuy Cemented Hip Prosthesis, Depuy, Inc. (1994) Summary page 1.
- K900638: P.F.C. Hip System Non-Porous Femoral Component, Johnson & Johnson International (1990) Summary page 1.
- K953694: Depuy Vision Aml Hip Prothesis, Depuy, Inc. (1996) Summary page 1.

## Most influential descendants
- K023453: Depuy Summit FX Cemented Hip Prosthesis (2002), 29 descendants of its own
- K170339: Summit Hip System (2018), 27 descendants of its own
- K193398: Summit DuoFix HA Coating (2020), 20 descendants of its own
- K202472: ACTIS Duofix Hip Prosthesis (2020), 15 descendants of its own
- K210581: Actis DuoFix Hip Prosthesis- Collarless (2021), 13 descendants of its own

## Indications for use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. 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. Cemented Components: Femoral stem and acetabular cup total hip components labelled “For cemented use only” are indicated only for use with bone cement. This device is intended for single use.

Source page: https://510kreport.com/device/K013352
Methodology: https://510kreport.com/methodology