# K023901: Alumina V40 Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 28, 2003 after 67 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
Longest line of descent: 1 generation back to K003413 (2000). 1 ancestor in all.
19 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003413: Alumina V40 Head, Howmedica Osteonics Corp. (2000)

## Most influential descendants
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (2020), 6 descendants of its own

## Indications for use
The subject femoral head is a single-use device intended for use in total hip replacement. It is intended for use with any currently available Howmedica Osteonics acetabular component. It is intended for use with any currently available Howmedica Osteonics hip stem featuring the V40™ trunnion and manufactured from a titanium alloy or Orthinox™ Stainless Stzel. It is not intended for use with any stem manufactured from cobalt chromium alloy. Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant); Rheumatoid arthritis; Correction of functional deformity; Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum; Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable uing other techniques; Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K023901
Methodology: https://510kreport.com/methodology