Cleared Traditional

K212487 - CoLink Vallux Plating System

K212487 is the FDA 510(k) clearance for CoLink Vallux Plating System by In2bones USA, LLC. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K212487 · In2bones USA, LLC · Orthopedic device
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Nov 2021
Decision
101d
Days
Class 2
Risk

K212487 is an FDA 510(k) clearance for the CoLink Vallux 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 November 18, 2021 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all In2bones USA, LLC devices

Submission Details

510(k) Number K212487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2021
Decision Date November 18, 2021
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 904
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K212487.
CoLink NeoFuse Plating System
K213069 · In2bones USA, LLC · Dec 2021
The Radian MIS Bunion System
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Xpert Wrist
K213214 · Newclip Technics · Nov 2021
Stratum® Ankle Fusion Plating System
K212640 · Nextremity Solutions, Inc. · Nov 2021
LOQTEQ Proximal Humerus Plate 3.5 System
K211582 · Aap Implantate AG · Oct 2021
SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System
K203002 · Bonebridge AG · Oct 2021