# K053293: Encompass 10*17 and 12*17 Extended Press-Fit Hip Stems

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Feb 16, 2006 after 83 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132697: Encompass 10/12 Hip Stem (2014), 0 descendants of its own

## Recalls of this device
- May 10, 2011 · Not classified · Z-2602-2011: Tests on PVC packaging material resulted in alert levels for cytotoxicity.
- May 10, 2011 · Not classified · Z-2603-2011: Tests on PVC packaging material resulted in alert levels for cytotoxicity.

## Indications for use
The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only. 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 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/K053293
Methodology: https://510kreport.com/methodology