# K022077: 36MM V40 Femoral Head Components (Lfit and Non-Lfit)

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 25, 2002 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: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910988 (1991). 5 ancestors in all.
298 later devices descend from it; 6 cite it directly.
0 of 304 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010757: Lfit V40 Femoral Head Components, Howmedica Osteonics Corp. (2001) Summary page 1.
- K936126: Howmedics DRG Femoral Component, Howmedica, Inc. (1994) Summary page 1.
- K950541: Howmedica V40 22MM Femoral Head, Howmedica Corp. (1995) Summary page 1.
- K993601: Howmedica Osteonics Femoral Heads, Howmedica Osteonics Corp. (1999) Summary page 1.

## Most influential descendants
- 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
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own

## Recalls of this device
- May 22, 2018 · Class II · Z-2294-2018: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
- May 22, 2018 · Class II · Z-2297-2018: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
- May 22, 2018 · Class II · Z-2293-2018: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
- May 22, 2018 · Class II · Z-2299-2018: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
- May 22, 2018 · Class II · Z-2295-2018: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
- May 22, 2018 · Class II · Z-2292-2018: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
- May 22, 2018 · Class II · Z-2296-2018: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
- May 22, 2018 · Class II · Z-2298-2018: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
- Aug 29, 2016 · Class II · Z-0378-2017: Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
- 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.
- Jun 18, 2009 · Not classified · Z-1822-2009: Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.

## 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/K022077
Methodology: https://510kreport.com/methodology