Cleared Traditional

K100944 - CLAVICLE LOCKING PLATE SYSTEM

K100944 is the FDA 510(k) clearance for CLAVICLE LOCKING PLATE SYSTEM by Newclip Technics. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K100944 · Newclip Technics · Orthopedic device
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Oct 2010
Decision
199d
Days
Class 2
Risk

K100944 is an FDA 510(k) clearance for the CLAVICLE LOCKING PLATE 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 Newclip Technics (Round Rock, US). The FDA issued a Cleared decision on October 22, 2010 after a review of 199 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 Newclip Technics devices

Submission Details

510(k) Number K100944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2010
Decision Date October 22, 2010
Days to Decision 199 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
77d slower than avg
Panel avg: 122d · This submission: 199d
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 886
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K100944.
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K100776 · Synthes (Usa) · Aug 2010