# K040644: Modification to Depuy Ceramic Femoral Head

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Apr 8, 2004 after 28 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: 2 generations back to K011533 (2002). 2 ancestors in all.
222 later devices descend from it; 3 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031803: Depuy Ceramic Femoral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K062748: Modification: to Depuy Delta Ceramic Femoral Head (2006), 219 descendants of its own
- K071535: Biolox Delta Ceramic Femoral Head (2007), 217 descendants of its own
- K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve (2008), 165 descendants of its own
- K083762: Biolox Delta Ceramic Femoral Heads (2009), 149 descendants of its own
- K100412: Biolox Delta Ceramic Femoral Heads (2010), 140 descendants of its own

## Indications for use
The DePuy Ceramic Femoral Head is 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 arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture 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/K040644
Methodology: https://510kreport.com/methodology