# K063225: Metaizeau Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 27, 2006 after 64 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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.
30 later devices descend from it; 2 cite it directly.
0 of 31 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 no predicate by number.

## Most influential descendants
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System (2008), 29 descendants of its own
- K082148: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension (2008), 14 descendants of its own
- K143276: Acumed Small Bone IM Nail System (2015), 10 descendants of its own
- K082375: Orthopediatrics Pediflex Flexible Nail System (2008), 10 descendants of its own
- K143355: The Simple Locking IntraMedullary (SLIM) System (2015), 6 descendants of its own

## Recalls of this device
- Jan 21, 2016 · Class II · Z-0868-2016: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

## Indications for use
The MetaizeauTM Nailing System is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. Specific indications include, but are not limited to: * Fixation of mid-diaphyseal, proximal and distal fractures of the femur and tibia in children, * Forearm fractures in children and young adolescents, and * Fractures of the humerus in adults.

Source page: https://510kreport.com/device/K063225
Methodology: https://510kreport.com/methodology