Cleared Traditional

CoLink NeoFuse MIS Plating System (see attached parts list) (K241387) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241387 · In2bones USA · Orthopedic device
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Aug 2024
Decision
90d
Days
Class 2
Risk

K241387 is an FDA 510(k) clearance for the CoLink NeoFuse MIS Plating System (see attached parts list). 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 (Memphis, US). The FDA issued a Cleared decision on August 13, 2024 after a review of 90 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 devices

Submission Details

510(k) Number K241387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2024
Decision Date August 13, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 700
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K241387.
SITTER 3.5mm Versatile System
K240318 · Bonebridge AG · Aug 2024
RibFix Titan™ Fixation System
K241282 · Riverpoint Medical · Aug 2024
NCB® Polyaxial Locking Plate System
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Freefix Forearm Plating System
K242055 · Skeletal Dynamics, Inc. · Aug 2024
Activmotion S
K241539 · Newclip Technics · Jul 2024
VOLT™ Proximal Humerus 3.5 Plating System
K233994 · Synthes GmbH · Jul 2024