# K241359: Medline UNITE® MIS Foot Recon Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Aug 2, 2024 after 80 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 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® MIS Foot Recon Screw System is indicated for the stabilization and fixation of bone reconstructions, osteotomies, joint fusions (arthrodeses), and fractures of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle. Screws are intended for single use only.

Source page: https://510kreport.com/device/K241359
Methodology: https://510kreport.com/methodology