# K955761: Tibia Orthonail

- Pathway: 510(k) (Traditional)
- Applicant: Orthologic Corp.
- Decided: Mar 13, 1996 after 86 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OrthoNail: named in the summary without a submission number
- (no number) True/Flex: named in the summary without a submission number
- (no number) Russell-Taylor Technologic: named in the summary without a submission number

## Indications for use
The Tibia OrthoNail is indicated for stabilizing tibial fractures.

Source page: https://510kreport.com/device/K955761
Methodology: https://510kreport.com/methodology