# K233233: EMPHASYS Femoral Stems

- Pathway: 510(k) (Special)
- Applicant: Depuy Ireland UC
- Decided: Oct 11, 2023 after 13 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: 18 generations back to K941847 (1994). 192 ancestors in all.
No later device cites it as a predicate yet.
0 of 192 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211657: EMPHASYS Femoral Stems, Depuy Ireland UC (2021) Summary page 6.
- K203167: DePuy Corail AMT Hip Prosthesis, DePuy Orthopaedics, Inc. (2020) Summary page 6.

## Indications for use
EMPHASYS Femoral Stems are intended for use in total and partial hip arthroplasty. The stems are intended only for uncemented 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. Partial hip arthroplasty (hip hemiarthroplasty) is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. EMPHASYS Femoral Stems are intended for single use only. 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. The EMPHASYS Femoral Stems are indicated for cementless use only.

Source page: https://510kreport.com/device/K233233
Methodology: https://510kreport.com/methodology