Cleared Traditional

K213698 - CoLink PCR Plating System

K213698 is the FDA 510(k) clearance for CoLink PCR 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 185-day FDA review.

K213698 · In2bones USA, LLC · Orthopedic device
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May 2022
Decision
185d
Days
Class 2
Risk

K213698 is an FDA 510(k) clearance for the CoLink PCR 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 May 27, 2022 after a review of 185 days - an extended review 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: 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 K213698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2021
Decision Date May 27, 2022
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
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 895
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K213698.
Arthrex Mini Fragment System
K220937 · Arthrex, Inc. · Jun 2022
Baby Gorilla/Gorilla Plating System
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Omni Foot and Ankle Plating System
K221362 · Exremity Medical, LLC · Jun 2022
CalcShift™ Displacement Calcaneal Osteotomy System
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Osteotomy Truss System (OTS)
K220463 · 4Web Medical, Inc. · May 2022
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K212782 · Biomet Microfixation · May 2022