Cleared Special

K232905 - Medline UNITE REFLEX Nitinol Staple Kit

K232905 is the FDA 510(k) clearance for Medline UNITE REFLEX Nitinol Staple Kit by Medline Industries, LP. It is a Class 2 Orthopedic device (product code JDR) cleared through the Special 510(k) pathway after a 30-day FDA review.

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.

Regulatory Peers - JDR Staple, Fixation, Bone

All 97
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K232905.
COGNiTiON™ Staple System
K240212 · Ortho Solutions UK , Ltd. · Feb 2024
A’TOMIC™ Nitinol Fixation System
K232990 · Rmr Ortho, LLC · Jan 2024
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
K230724 · Novastep · Dec 2023
StealthFix Intraosseous Fixation System
K232324 · Medartis, Inc. · Aug 2023
Treace Medical Concepts (TMC) Compression Implant System
K232387 · Treace Medical Concepts · Aug 2023
NITINEX Memory Compression Staple
K231493 · Vilex, LLC · Aug 2023