# K941366: Osteonics Omnifit AD-HA Hip Stem Series

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jun 6, 1995 after 442 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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
No predicates in its family tree.
241 later devices descend from it; 3 cite it directly.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K993768: Citation TMZF HA Stem (2000), 224 descendants of its own
- K001448: Trident Acetabular Shells: PS-HA (2000), 150 descendants of its own
- K013106: 2 Piece Modular Hip Stem (2002), 101 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own

## Recalls of this device
- Nov 13, 2008 · Not classified · Z-0902-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

Source page: https://510kreport.com/device/K941366
Methodology: https://510kreport.com/methodology