# K073637: Parallel-Sided Extensively Coated Femoral Stems

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 20, 2008 after 85 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K854046 (1985). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982367: Reach Hip Component, Biomet, Inc. (1998) Summary page 1.
- K012364: Aml Hip Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K052089: XR-Series BI-Metric Femoral Components, Biomet Manufacturing, Inc. (2006) Summary page 1.

## Indications for use
1. Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision of previous failed total hip arthroplasty. The Parallel-Sided Extensively Coated Femoral Stems are for uncemented applications only.

Source page: https://510kreport.com/device/K073637
Methodology: https://510kreport.com/methodology