# K243888: Medline UNITE®  REFLEX®  Hybrid Nitinol Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Apr 11, 2025 after 114 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: 12 generations back to K954385 (1996). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 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 5.
- K234031: Medline UNITE Ancillary Foot Recon Plating System, Medline Industires, LP (2024) Summary page 6.
- K241359: Medline UNITE® MIS Foot Recon Screw System, Medline Industries, LP (2024) Summary page 6.
- K211612: Medline UNITE REFLEX Dynamic Discs, Medline Industries, Inc. (2021) Summary page 6.

## Indications for use
The Medline UNITE® REFLEX® Hybrid Nitinol Implants are intended to provide fixation for fractures, fusions or osteotomies of the bones of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle such as: First metatarsalcuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, Lis-Franc arthrodesis, Scarf and Chevron osteotomies. Implants are intended for single use only. The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® REFLEX® Hybrid Nitinol Implant. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K243888
Methodology: https://510kreport.com/methodology