Cleared Traditional

K2M COCR WIRE (K103797) - FDA 510(k) Clearance

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

K103797 · K2m, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2011
Decision
144d
Days
Class 2
Risk

K103797 is an FDA 510(k) clearance for the K2M COCR WIRE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on May 20, 2011 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 K2m, Inc. devices

Submission Details

510(k) Number K103797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2010
Decision Date May 20, 2011
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 50
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K103797.
Suture Wires and Wire Loops
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K133354 · Biomet, Inc. · Jan 2014
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205 · Synthes (Usa) · Jul 2008
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017 · Aesculap, Inc. · Dec 2006
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K050041 · Synthes (Usa) · Feb 2005