# K211612: Medline UNITE REFLEX Dynamic Discs

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Dec 10, 2021 after 198 days
- Product code: HTN (Washer, Bolt Nut)
- 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 K082320 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130319: Medline Cannulated Screw, Medline Industries, Inc. (2013) Summary page 4.

## Most influential descendants
- K243888: Medline UNITE®  REFLEX®  Hybrid Nitinol Implant System (2025), 0 descendants of its own

## Indications for use
The Medline UNITE® REFLEX™ Dynamic Discs are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Discs are intended for single use only.

Source page: https://510kreport.com/device/K211612
Methodology: https://510kreport.com/methodology