Cleared Traditional

K243888 - Medline UNITE® REFLEX® Hybrid Nitinol Implant System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

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Submission Details

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.

Device Classification

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.