Cleared Special

K182402 - CoLink View Plating System

K182402 is the FDA 510(k) clearance for CoLink View Plating System by In2bones USA, LLC. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 23-day FDA review.

K182402 · In2bones USA, LLC · Orthopedic device
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Sep 2018
Decision
23d
Days
Class 2
Risk

K182402 is an FDA 510(k) clearance for the CoLink View Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on September 27, 2018 after a review of 23 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 In2bones USA, LLC devices

Submission Details

510(k) Number K182402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date September 27, 2018
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 914
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K182402.
ORTHOLOC SPS Shoulder Plating System
K181587 · Tornier, Inc. · Oct 2018
WishBone Medical Plate and Screw System
K180736 · Wishbone Medical, Inc. · Oct 2018
ARIX Clavicle System
K180972 · Jeil Medical Corporation · Oct 2018
Tandry Locking Plate System
K171904 · Microware Precision Co., Ltd. · Sep 2018
APTUS CMC-I Fusion Plate System
K181009 · Medartis AG · Aug 2018
AOS Small Fragment Plating System Lite
K181035 · Advanced Orthopaedic Solutions, Inc. (Aos) · Aug 2018