# K052718: V40 Biolox Delta Ceramic Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 27, 2005 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
186 later devices descend from it; 6 cite it directly.
0 of 187 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 its predicate without a number.
- (no number) Alumina V40 Ceramic Femoral Heads: named in the summary without a submission number

## Most influential descendants
- K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve (2008), 165 descendants of its own
- K100412: Biolox Delta Ceramic Femoral Heads (2010), 140 descendants of its own
- K103120: Corin Biolox Delta Femoral Heads (2011), 110 descendants of its own
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own
- K111911: Corin Optimom Modular Head (2011), 62 descendants of its own

## Recalls of this device
- Jan 14, 2022 · Class II · Z-0842-2022: Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
- Jan 14, 2022 · Class II · Z-0843-2022: Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

## Indications for use
The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads are as follows: For Use as a Total Hip Replacement: * Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage vascular necrosis. * Revision of previous cup arthroplasty or other procedures * Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. For Use as a Bipolar Hip Replacement * Femoral head/neck fractures or non-unions. * Asceptic necrosis of the femoral head. * Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: * Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. * Salvage of failed total hip arthroplasty

Source page: https://510kreport.com/device/K052718
Methodology: https://510kreport.com/methodology