# K251052: Trivicta® Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: May 22, 2025 after 49 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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: 16 generations back to K941847 (1994). 268 ancestors in all.
No later device cites it as a predicate yet.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233758: Trivicta™ Hip Stem, Ortho Development Corp. (2024) Summary page 5.
- K150862: DePuy Actis Duofox Hip Prosthesis, DePuy Orthopaedics, Inc. (2015) Summary page 5.

## Indications for use
This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Source page: https://510kreport.com/device/K251052
Methodology: https://510kreport.com/methodology