# K010757: Lfit V40 Femoral Head Components

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 11, 2001 after 29 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910988 (1991). 1 ancestor in all.
300 later devices descend from it; 5 cite it directly.
0 of 302 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910988: Osteonics Ion Implanted Femoral Bearing Series, Osteonics Corp. (1991) Summary page 1.

## Most influential descendants
- K022077: 36MM V40 Femoral Head Components (Lfit and Non-Lfit) (2002), 298 descendants of its own
- K040191: Bicontact Hip Stem and Femoral Head (2004), 267 descendants of its own
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K043079: Bicontact Hip System with U-Cap (2004), 166 descendants of its own
- K093472: Trinity Acetabular System (2010), 117 descendants of its own

## Recalls of this device
- Feb 3, 2015 · Class II · Z-1241-2015: Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corr
- Sep 4, 2009 · Not classified · Z-0390-2010: Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
- Sep 4, 2009 · Not classified · Z-0391-2010: Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
- Nov 2, 2007 · Not classified · Z-0962-2008: Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with 

## Indications for use
These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

Source page: https://510kreport.com/device/K010757
Methodology: https://510kreport.com/methodology