# K211657: EMPHASYS Femoral Stems

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Aug 5, 2021 after 69 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: 17 generations back to K941847 (1994). 190 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190344: DePuy Corail AMT Hip Prosthesis, Depuy (Ireland) (2019) Summary page 4.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 4.
- K123991: Depuy Corail Amt Hip Prosthesis, Depuy France S.A.S. (2013) Summary page 4.
- K173960: DePuy Corail AMT Hip Prosthesis, Depuy France S.A.S. (2018) Summary page 4.
- K192946: DePuy Corail AMT Hip Prosthesis, DePuy Orthopaedics, Inc. (2019) Summary page 4.
- K001991: Titan Porocoat Hip Prosthesis, DePuy Orthopaedics, Inc. (2000) Summary page 4.
- K170339: Summit Hip System, DePuy Orthopaedics, Inc. (2018) Summary page 5.
- K210581: Actis DuoFix Hip Prosthesis- Collarless, Depuy Ireland UC (2021) Summary page 5.

## Most influential descendants
- 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
- K243977: EMPHASYS Acetabular System (2025), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K252067: Velora Acetabular System (2025), 0 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. Partial 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 hip hemiarthroplasty.

Source page: https://510kreport.com/device/K211657
Methodology: https://510kreport.com/methodology