# K031803: Depuy Ceramic Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 1, 2003 after 20 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 K011533 (2002). 1 ancestor in all.
377 later devices descend from it; 9 cite it directly.
0 of 379 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011533: Depuy Femoral Heads, DePuy Orthopaedics, Inc. (2002)

## Most influential descendants
- K042091: Biolox Delta Ceramic Heads (2005), 345 descendants of its own
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own
- K040644: Modification to Depuy Ceramic Femoral Head (2004), 222 descendants of its own
- K062748: Modification: to Depuy Delta Ceramic Femoral Head (2006), 219 descendants of its own

## Indications for use
The DePuy Ceramic Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic artlmtis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic hcture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.

Source page: https://510kreport.com/device/K031803
Methodology: https://510kreport.com/methodology