# K171249: Entrada™ hip stem

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Aug 24, 2017 after 118 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: 14 generations back to K941847 (1994). 264 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953111: Corail, Landos, Inc. (1996) Summary page 4.
- K093736: Depuy Corail Hip System, Revision Stem, DePuy Orthopaedics, Inc. (2011) Summary page 4.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 4.
- K070554: Depuy Corail Amt Dysplasia Hip Prosthesis, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K123991: Depuy Corail Amt Hip Prosthesis, Depuy France S.A.S. (2013) Summary page 4.
- K133386: Ovation Tribute Hip Stem; Ovation Narrow Hip Stem, Ortho Development Corp. (2014) Summary page 4.
- K153649: Exactech® Novation® Element Press-fit Femoral Stem, Exactech, Inc. (2016) Summary page 4.

## Most influential descendants
- K233758: Trivicta™ Hip Stem (2024), 1 descendant of its own
- K251052: Trivicta® Hip Stem (2025), 0 descendants of its own

## 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/K171249
Methodology: https://510kreport.com/methodology