# K983404: Type 3 Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Dec 22, 1998 after 85 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921308 (1994). 7 ancestors in all.
102 later devices descend from it; 1 cites it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972893: Partnership Revision  Femoral Stems, Howmedica Corp. (1997) Summary page 1.
- K954559: Howmedicca Modular Proximal Humerus Replacement System, Howmedica Corp. (1996) Summary page 1.
- K960588: Wagner Revision Stem, Intermedics Orthopedics (1996) Summary page 1.
- (no number) MP Reconstruction Hip System: named in the summary without a submission number

## Most influential descendants
- K013106: 2 Piece Modular Hip Stem (2002), 101 descendants of its own
- K022549: Restoration Modular System (2002), 54 descendants of its own
- K103479: Novel Tapered Hip Stem (2011), 53 descendants of its own
- K120578: Accolade II Hip Stem (2012), 46 descendants of its own
- K090757: Biomet Modular Femoral Revision System (2009), 37 descendants of its own

## Recalls of this device
- Dec 30, 2003 · Not classified · Z-0571-04: Restoration T3 Revision Hip System distal stem has demonstrated fractures.

## Indications for use
The Type 3 Femoral Components are intended to be used in primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. These stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components. These femoral stems are designed to be press fit into the proximal femur.

Source page: https://510kreport.com/device/K983404
Methodology: https://510kreport.com/methodology