Cleared Traditional

K103797 - K2M COCR WIRE

K103797 is an FDA 510(k) clearance for K2M COCR WIRE, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K103797 · K2m, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K103797

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
Combination Product No
PCCP Authorized No
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.

JDQ Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K103797.
PASS LP SPINAL
K112736 · Medicrea International · Feb 2012
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011
FIGURE 8 STERNOTOMY CLOSURE DEVICE
K110541 · Figure 8 Surgical, Incorporated · Jul 2011
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
K110039 · Biomet Sports Medicine · May 2011
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K091190 · Zimmer Spine, Inc. · Jul 2009
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
K081622 · Abbott Spine, Inc. · Aug 2008