Cleared Special

K193543 - CoLink Plating System

K193543 is the FDA 510(k) clearance for CoLink 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 28-day FDA review.

K193543 · In2bones USA, LLC · Orthopedic device
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Jan 2020
Decision
28d
Days
Class 2
Risk

K193543 is an FDA 510(k) clearance for the CoLink Plating System, Fracture and Correction System, CoLink Mini Plating Sy.... 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 January 17, 2020 after a review of 28 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 K193543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date January 17, 2020
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 K193543.
Comus Locking Plate systems
K190842 · Jiangsu Trauhui Medical Instrument Co., Ltd. · Feb 2020
APTUS Clavicle System
K192984 · Medartis AG · Jan 2020
Tyber Medical Anatomical Plating System
K193222 · Tyber Medical, LLC · Jan 2020
MotoBAND CP Implant System
K193452 · Crossroads Extemity Systems, LLC · Jan 2020
TriMed ASET Foot Plating System
K192696 · TriMed, Inc. · Jan 2020
Mini and Micro Fragments Reconstruction System – GMReis
K182718 · Gm Dos Reis Industria E Comerico Ltda. · Dec 2019