Cleared Traditional

K243888 - Medline UNITE® REFLEX® Hybrid Nitinol Implant System

K243888 is an FDA 510(k) clearance for Medline UNITE REFLEX Hybrid Nitinol Imp..., manufactured by Medline Industries, LP. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 114-day FDA review.

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

K243888 is an FDA 510(k) clearance for the Medline UNITE® REFLEX® Hybrid Nitinol Implant System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfield, US). The FDA issued a Cleared decision on April 11, 2025 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, LP devices

FDA 510(k) Submission Details - K243888

510(k) Number K243888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDR Staple, Fixation, Bone

All 189
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K243888.
Megalodon Dynamic Compression System
K261121 · Paragon 28, Inc. · Aug 2026
Linkt Compression Staple System
K250712 · Trax Surgical · May 2025
Arthrex DynaNite Nitinol Staples
K243742 · Arthrex, Inc. · Jan 2025
TMC Compression Implant System
K243658 · Treace Medical Concepts · Dec 2024
TMC Compression Implant System
K242415 · Treace Medical Concepts · Sep 2024
COGNiTiON™ Staple System
K240212 · Ortho Solutions UK , Ltd. · Feb 2024