# K170339: Summit Hip System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Apr 26, 2018 after 448 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K941847 (1994). 182 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 209 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 4.
- K011489: Summit Duofix Hip Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 4.
- K013352: Summit Cemented Hip Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 4.
- K023453: Depuy Summit FX Cemented Hip Prosthesis, DePuy Orthopaedics, Inc. (2002) Summary page 4.
- K030122: Depuy Summit Basic Press-Fit Hip Stem, DePuy Orthopaedics, Inc. (2003) Summary page 4.
- K150862: DePuy Actis Duofox Hip Prosthesis, DePuy Orthopaedics, Inc. (2015) Summary page 4.
- K123991: Depuy Corail Amt Hip Prosthesis, Depuy France S.A.S. (2013) Summary page 4.

## Most influential descendants
- 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
- K211657: EMPHASYS Femoral Stems (2021), 7 descendants of its own

## Indications for use
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. Hemi hip replacement is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only. The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.

Source page: https://510kreport.com/device/K170339
Methodology: https://510kreport.com/methodology