# K023453: Depuy Summit FX Cemented Hip Prosthesis

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 13, 2002 after 29 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: 2 generations back to K900638 (1990). 4 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013352: Summit Cemented Hip Prosthesis, DePuy Orthopaedics, Inc. (2001)

## Most influential descendants
- 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
- K211703: Insignia Hip Stem (2021), 7 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: A severely painful andor disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia; Avascular necrosis of the femoral head; Acute traumatic fracture of the femoral head or neck; Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; Certain cases of ankylosis. The Summit FX Cemented Hip Stem is intended for cemented use only.

Source page: https://510kreport.com/device/K023453
Methodology: https://510kreport.com/methodology