# K173051: Orthofix MJ-FLEX THE NEW METAIZEAU NAIL

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Nov 16, 2017 after 49 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960642 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082375: Orthopediatrics Pediflex Flexible Nail System, OrthoPediatrics Corp. (2008) Summary page 4.

## Indications for use
The MJ-FLEX THE NEW METAIZEAU NAIL™ is intended for the treatment of diaphyseal fractures of long bones. The MJ-FLEX THE NEW METAIZEAU NAIL™ is indicated to treat: - upper extremity and clavicle fractures in all patients except newborns and infants; - lower extremity fractures in pediatric patients, except newborns and infants, where the flexibility of the implant is paramount not to disrupt the growth plate; - lower extremity fractures in small adults where the medullary canal is narrow.

Source page: https://510kreport.com/device/K173051
Methodology: https://510kreport.com/methodology