# K022531: 2MM Pediatric Flex Nail

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Aug 26, 2002 after 26 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K000764 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
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)

## Most influential descendants
- K193533: WIN Flexible Nail System (2020), 0 descendants of its own

## Indications for use
Flexible Pediatric Fixation Nails 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/K022531
Methodology: https://510kreport.com/methodology