# K972516: Synthes (Usa) Flexible Humeral Nail (Flex Nail) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 4, 1997 after 59 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953334 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953334: Synthes Flexnail, Synthes (Usa) (1995) Summary page 1.

## Indications for use
The Synthes FlexNail is intended for treatment of humeral shaft fractures: specifically, it is for treatment of acute humeral shaft fractures, including certain pre- and post-isthmal fractures (including, but not limited to transverse, short oblique, long oblique, butterfly, and segmental fractures, of all grades of comminution); pathologic or impending pathologic fractures; and non- and malunions of the humeral shaft.

Source page: https://510kreport.com/device/K972516
Methodology: https://510kreport.com/methodology