# K254043: TRIVANCE™ Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Aug 4, 2026 after 230 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: 18 generations back to K941847 (1994). 210 ancestors in all.
No later device cites it as a predicate yet.
0 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190276: Provident II Hip Stem, Stelkast, Inc. (2019) Summary page 5.
- K210581: Actis DuoFix Hip Prosthesis- Collarless, Depuy Ireland UC (2021) Summary page 5.
- K202472: ACTIS Duofix Hip Prosthesis, DePuy Orthopaedics, Inc. (2020) Summary page 5.
- K160907: DePuy Actis DuoFix Hip Prosthesis, Depuy (Ireland) (2016) Summary page 5.
- K150862: DePuy Actis Duofox Hip Prosthesis, DePuy Orthopaedics, Inc. (2015) Summary page 5.
- K001984: Progeny Forged Cocr Cemented Femoral Component, Stelkast Company (2000) Summary page 5.
- K220216: C-Stem AMT LE Prosthesis, Depuy Ireland UC (2022) Summary page 5.
- K082239: Depuy C-Stem Amt, DePuy Orthopaedics, Inc. (2008) Summary page 5.
- K982918: Depuy C-Stem System, DePuy Orthopaedics, Inc. (1998) Summary page 5.

## Indications for use
The TRIVANCE™ stems are intended for total and hemi-hip arthroplasty in skeletally mature patients for the following indications: 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The TRIVANCE™ stems are intended for cemented and uncemented applications.

Source page: https://510kreport.com/device/K254043
Methodology: https://510kreport.com/methodology