# K210285: Adaptable Ortho Innovations Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Adaptable Ortho Innovations, LLC
- Decided: Mar 18, 2021 after 44 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970097 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142281: Zimmer M/DN Intramedullary Fixation System, Zimmer, Inc. (2014) Summary page 4.

## Indications for use
The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

Source page: https://510kreport.com/device/K210285
Methodology: https://510kreport.com/methodology