# K210482: Medline UNITE REFLEX Nitinol Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Apr 22, 2021 after 62 days
- Product code: JDR (Staple, 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: 4 generations back to K902307 (1990). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124045: Fuseforce Implant System, Solana Surgical, LLC (2013) Summary page 5.

## Most influential descendants
- K231885: Medline UNITE® REFLEX® Nitinol Staple System (2023), 3 descendants of its own
- K250712: Linkt Compression Staple System (2025), 0 descendants of its own
- K243888: Medline UNITE®  REFLEX®  Hybrid Nitinol Implant System (2025), 0 descendants of its own
- K232905: Medline UNITE® REFLEX® Nitinol Staple Kit (2023), 0 descendants of its own

## Indications for use
The Medline UNITE REFLEX Nitinol Staples are intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as : LisFranc arthrodesis, Akin Osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.

Source page: https://510kreport.com/device/K210482
Methodology: https://510kreport.com/methodology