# K030122: Depuy Summit Basic Press-Fit Hip Stem

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 5, 2003 after 22 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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 K000392 (2000). 1 ancestor in all.
28 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000392: Response 2000 Hip Stem, DePuy Orthopaedics, Inc. (2000)

## 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 and/or 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.

Source page: https://510kreport.com/device/K030122
Methodology: https://510kreport.com/methodology