# K953334: Synthes Flexnail

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 31, 1995 after 106 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Applied Osteo Systems, Inc. TrueFlex Humeral Nail: named in the summary without a submission number

## Most influential descendants
- K972516: Synthes (Usa) Flexible Humeral Nail (Flex Nail) System (1997), 0 descendants of its own

## Indications for use
The Applied Osteo Systems, Inc. TrueFlex Humeral Nail is also intended to treat fractures of the humeral shaft. Specifically, it is intended for humeral shaft fractures of all patterns, within a range from 3cm distal to the surgical neck to 5cm proximal to the olecranon; transverse, short oblique; long oblique; butterfly; segmental and all grades of comminution.

Source page: https://510kreport.com/device/K953334
Methodology: https://510kreport.com/methodology