# K133386: Ovation Tribute Hip Stem; Ovation Narrow Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Mar 11, 2014 after 126 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: 7 generations back to K850055 (1985). 100 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 103 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.
- K131022: Ovation 10/12 Hip Stem, Ortho Development Corp. (2013) Summary page 3.
- K110400: Taperloc Complete Microplasty Stem, Biomet Manufacturing Corp (2011) Summary page 3.
- K103256: Smith & Nephew SMF Hip Stem, Smith & Nephew, Inc. (2011) Summary page 3.

## Most influential descendants
- 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

## Indications for use
1. Notably impaired hipjolint due to ostcoarthritis, rheumatoid arthritis and/or post traumatic arthritis. 2. Previously tailed hip surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avosculor necrosis of femoral head. 5. Non-union of proximal femnoral neck fractures. 6. Treatment of fractures that are unmanageable using other foyms of therapy. 7. Benign or malignant bone tumors, congenital dysplasla or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Source page: https://510kreport.com/device/K133386
Methodology: https://510kreport.com/methodology