Cleared Traditional

K163293 - Colink Plating System

K163293 is an FDA 510(k) clearance for Colink Plating System, manufactured by In2bones USA, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K163293 · In2bones USA, LLC · Orthopedic device
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May 2017
Decision
164d
Days
Class 2
Risk

K163293 is an FDA 510(k) clearance for the Colink™ 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 5, 2017 after a review of 164 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

FDA 510(k) Submission Details - K163293

510(k) Number K163293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2016
Decision Date May 05, 2017
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 Consultant

Enmed International, Inc.
LOUISE FOCHT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K163293.
EVOS Small Fragment Lower Extremity Plates
K170457 · Smith & Nephew, Inc. · Jun 2017
Piccolo Composite® Plate System
K170401 · CarboFix Orthopedics , Ltd. · May 2017
VariAx 2 Foot System
K170771 · Stryker GmbH · May 2017
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
K163650 · Wrightmedicaltechnologyinc · Apr 2017
EVOS Small Fragment Plating System
K170887 · Smith & Nephew, Inc. · Apr 2017
ANTHEM™ Fracture System
K163361 · Globus Medical, Inc. · Apr 2017