# K011489: Summit Duofix Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 31, 2001 after 77 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K935452 (1994). 25 ancestors in all.
40 later devices descend from it; 5 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001991: Titan Porocoat Hip Prosthesis, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K980711: Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating, Zimmer, Inc. (1998) Summary page 1.
- K001277: Triflange Acetabular Cup System, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K150862: DePuy Actis Duofox Hip Prosthesis (2015), 38 descendants of its own
- K170339: Summit Hip System (2018), 27 descendants of its own
- K160907: DePuy Actis DuoFix Hip Prosthesis (2016), 26 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

## 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 bead or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, herniarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The Summit Duofix™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Source page: https://510kreport.com/device/K011489
Methodology: https://510kreport.com/methodology