# K132697: Encompass 10/12 Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jun 20, 2014 after 295 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: 6 generations back to P960047 (1997). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053293: Encompass 10*17 and 12*17 Extended Press-Fit Hip Stems, Ortho Development Corp. (2006) Summary page 1.
- K953977: Primaloc Cementless Hip System, Ortho Development Corp. (1996) Summary page 1.
- K131022: Ovation 10/12 Hip Stem, Ortho Development Corp. (2013). Cleared while this submission was under review Summary page 1.
- K020580: X-Series BI-Metric Hip Femoral Components, Biomet, Inc. (2002) Summary page 2.

## Indications for use
This device is intended for use in total 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 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 unmianageable 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/K132697
Methodology: https://510kreport.com/methodology