# K973614: Foundation Unipolar Femoral Head with Modular Neck Length Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Dec 18, 1997 after 86 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K990309: Plus Fracture Head Prosthesis (1999), 1 descendant of its own
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

## Indications for use
The Foundation® Unipolar femoral head is intended for treatment of patients who are candidates for hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis of femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the srugeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with any stem that has the appropriate size head. This submission includes the unipolar femoral head with a modular neck length sleeve.

Source page: https://510kreport.com/device/K973614
Methodology: https://510kreport.com/methodology