Cleared Traditional

K231885 - Medline UNITE REFLEX Nitinol Staple System

K231885 is the FDA 510(k) clearance for Medline UNITE REFLEX Nitinol Staple System by Medline Industries, LP. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K231885 · Medline Industries, LP · Orthopedic device
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Aug 2023
Decision
43d
Days
Class 2
Risk

K231885 is an FDA 510(k) clearance for the Medline UNITE® REFLEX® Nitinol Staple System. 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 August 9, 2023 after a review of 43 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medline Industries, LP devices

Submission Details

510(k) Number K231885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2023
Decision Date August 09, 2023
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
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.

Regulatory Peers - JDR Staple, Fixation, Bone

All 99
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K231885.
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
Extremity Staple
K231458 · Restor3d · Aug 2023
JAWS Nitinol Staple System
K230550 · Paragon 28, Inc. · May 2023
JAWS Nitinol Staple System
K223056 · Paragon 28, Inc. · Feb 2023