# K051737: Modification to V-40/C-Taper Adapter Sleeve

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 19, 2005 after 21 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
No predicates in its family tree.
59 later devices descend from it; 3 cite it directly.
0 of 60 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 no predicate by number.

## Most influential descendants
- K100445: Klassic HD Hip System (2010), 25 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K143407: Klassic HD Hip System (2014), 16 descendants of its own
- K141972: Klassic HD Acetabular Insert with E-Link Poly (2014), 14 descendants of its own
- K071830: Depuy Delta TS Ceramic Femoral Heads (2007), 14 descendants of its own

## Indications for use
The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' adapter sleeves is 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. Aseptic 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/K051737
Methodology: https://510kreport.com/methodology