# K232905: Medline UNITE® REFLEX® Nitinol Staple Kit

- Pathway: 510(k) (Special)
- Applicant: Medline Industries, LP
- Decided: Oct 19, 2023 after 30 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: 6 generations back to K902307 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231885: Medline UNITE® REFLEX® Nitinol Staple System, Medline Industries, LP (2023) Summary page 4.
- K210482: Medline UNITE REFLEX Nitinol Staple System, Medline Industries, Inc. (2021) Summary page 4.
- K162354: Sniper Staple System, Trilliant Surgical, Ltd. (2017) Summary page 5.

## 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: First metatarsalcuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.

Source page: https://510kreport.com/device/K232905
Methodology: https://510kreport.com/methodology