# K030979: Modification to Depuy Solution System Hip Prosthesis

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Apr 24, 2003 after 27 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: 3 generations back to K931641 (1994). 5 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953703: Depuy Vision Solution Hip Prosthesis, Depuy, Inc. (1996) Summary page 1.
- K012364: Aml Hip Prosthesis, DePuy Orthopaedics, Inc. (2001)

## Most influential descendants
- K060581: Depuy Solution System Hip Prosthesis (2006), 9 descendants of its own
- K102080: Depuy Reclaim Revision Hip System (2010), 7 descendants of its own
- K221462: DePuy Reclaim Monobloc Revision Femoral Stem (2022), 6 descendants of its own
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K251292: RECLAIM Monobloc Revision Femoral Stem (2025), 1 descendant 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 andor disabled joint from osteoarthntis, traumatic arthritis, rheumatoid arthntis, 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. The DePuy Solution System Hip System is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.

Source page: https://510kreport.com/device/K030979
Methodology: https://510kreport.com/methodology