# K193533: WIN Flexible Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 20, 2020 after 62 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: 2 generations back to K000764 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000764: Pediatric Fixation Rods, Biomet, Inc. (2000) Summary page 4.
- K022531: 2MM Pediatric Flex Nail, Biomet, Inc. (2002) Summary page 4.

## Indications for use
WIN Nails (for use in pediatric patients) are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

Source page: https://510kreport.com/device/K193533
Methodology: https://510kreport.com/methodology