# K993601: Howmedica Osteonics Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 16, 1999 after 22 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
299 later devices descend from it; 4 cite it directly.
0 of 300 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) V40™ femoral heads: named in the summary without a submission number
- (no number) P.C.A.® femoral heads: named in the summary without a submission number

## 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
- 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/K993601
Methodology: https://510kreport.com/methodology