# K955563: Foundation Forged, Textured & Porous Stems W/Biolox Ceramic Heads

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Aug 9, 1996 after 247 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K930963 (1994). 1 ancestor in all.
1 later device descends 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)
- K930963: SL-Plus & SLR-Plus Stems W/Biolox Ceramic Heads, Encore Orthopedics, Inc. (1994) Summary page 1.

## Most influential descendants
- K082398: Encore Hip Stems with Ceramic Heads and Uhmwpe Liners (2008), 0 descendants of its own

## Indications for use
Biolox ceramic heads and Foundation™ Forged, Textured and Porous Stems are intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal.

Source page: https://510kreport.com/device/K955563
Methodology: https://510kreport.com/methodology