# K131022: Ovation 10/12 Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Oct 16, 2013 after 187 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: 5 generations back to P960047 (1997). 39 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062775: European Style Taper,Press-Fit Hip Stem, Ortho Development Corp. (2007) Summary page 1.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 1.
- K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 1.
- K010367: Modification to Titanium Tri-Lock Hips Stem, DePuy Orthopaedics, Inc. (2001) Summary page 1.

## Most influential descendants
- K133386: Ovation Tribute Hip Stem; Ovation Narrow Hip Stem (2014), 3 descendants of its own
- K171249: Entrada™ hip stem (2017), 2 descendants of its own
- K233758: Trivicta™ Hip Stem (2024), 1 descendant of its own
- K251052: Trivicta® Hip Stem (2025), 0 descendants of its own
- K132697: Encompass 10/12 Hip Stem (2014), 0 descendants of its own

## Indications for use
The Ovation 10/12 Hip Stem is indicated for use in uncemented total hip arthroplasty procedures 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 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/K131022
Methodology: https://510kreport.com/methodology