Cleared Special

K232905 - Medline UNITE® REFLEX® Nitinol Staple Kit (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232905 · Medline Industries, LP · Orthopedic device

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Oct 2023

Decision

30d

Days

Class 2

Risk

K232905 is an FDA 510(k) clearance for the Medline UNITE® REFLEX® Nitinol Staple Kit. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on October 19, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medline Industries, LP devices

Submission Details

510(k) Number	K232905 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 19, 2023
Decision Date	October 19, 2023
Days to Decision	30 days
Submission Type	Special
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

92d faster than avg

Panel avg: 122d · This submission: 30d

Pathway characteristics

Modification to existing cleared device.

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.