# K050637: Encompass Cemented Hip Stem & 10/12 Cobalt-Chrome Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Sep 23, 2005 after 196 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- 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
- K153216: Alpine Cemented Hip System (2016), 0 descendants of its own

## Indications for use
The device is intended for cemented use only. The device is intended for use in hip arthroplasty applications whose indications include: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia. 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/K050637
Methodology: https://510kreport.com/methodology