# K962248: P.F.C. Ceramic Hip Head

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Aug 29, 1996 after 79 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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 K933275 (1994). 1 ancestor in all.
12 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933275: P.F.C. Ceramic Hip Head, Johnson & Johnson Orthopaedics, Inc. (1994) Summary page 1.

## Most influential descendants
- K973307: S-Rom Zirconia Ceramic Femoral Hip Head (1997), 11 descendants of its own
- K980081: S-Rom Zirconia Ceramic Femoral Hip Head (1998), 10 descendants of its own
- K990261: Plus Ceramic Head Prostheses (Alumina and Zirkonia) (1999), 9 descendants of its own
- K012918: Apex Modular Alumina Femoral Head (2001), 7 descendants of its own
- K101451: Apex Module Hip System Biolox Delta Femoral Head (2010), 4 descendants of its own

## Indications for use
The Hip Stem components are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis and non-union of femoral fractures. These devices are indicated for use only with Bone Cement (PMMA). The P.F.C. Ceramic Hip Head is designed as a modular head, compatible with Johnson & Johnson Professional, Inc.’s femoral stems with a 12/14 Morse-type taper.

Source page: https://510kreport.com/device/K962248
Methodology: https://510kreport.com/methodology