# K082018: T2 Flexible Nail

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 10, 2008 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 no predicate by number.

## Indications for use
The T2TM Flexible Nail is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. This includes upper extremity fractures of all patients and lower extremity fractures of pediatric or small-statured patients. Specific indications include: * Fixation of mid-diaphyseal, proximal and distal fractures of the femur, tibia, and fibula in pediatric and small-statured patients. * Fixation of mid-diaphyseal, proximal and distal fractures of humerus and forearm fractures in all patients.

Source page: https://510kreport.com/device/K082018
Methodology: https://510kreport.com/methodology