Cleared Traditional

Medline UNITE? REFLEX? Hybrid Nitinol Implant System

K243888 · Medline Industries, LP · Orthopedic
Apr 2025
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K243888 is an FDA 510(k) clearance for the Medline UNITE? REFLEX? Hybrid Nitinol Implant System, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Medline Industries, LP (Northfield, US). The FDA issued a Cleared decision on April 11, 2025, 114 days after receiving the submission on December 18, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243888 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2024
Decision Date April 11, 2025
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030