# K153216: Alpine Cemented Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Feb 18, 2016 after 105 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
Longest line of descent: 1 generation back to K990369 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050637: Encompass Cemented Hip Stem & 10/12 Cobalt-Chrome Femoral Heads, Ortho Development Corp. (2005) Summary page 4.
- K990369: Synergy Cemented Hip Stem, Smith & Nephew, Inc. (1999) Summary page 4.

## Indications for use
This device is intended for use in total and hemi hip arthroplasty. The device is intended for single, cemented 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/K153216
Methodology: https://510kreport.com/methodology