Cleared Special

K073226 - CINCH KNOTLESS FIXATION IMPLANT SYSTEM

K073226 is the FDA 510(k) clearance for CINCH KNOTLESS FIXATION IMPLANT SYSTEM by C2m Medical, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 22-day FDA review.

K073226 · C2m Medical, Inc. · Orthopedic device
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Dec 2007
Decision
22d
Days
Class 2
Risk

K073226 is an FDA 510(k) clearance for the CINCH KNOTLESS FIXATION IMPLANT SYSTEM. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by C2m Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C2m Medical, Inc. devices

Submission Details

510(k) Number K073226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2007
Decision Date December 07, 2007
Days to Decision 22 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K073226.
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
K081511 · Smith & Nephew, Inc. · Aug 2008
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)
K081497 · Arthrocare Corp. · Jul 2008
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K080335 · Tornier, Inc. · Apr 2008
OPUS TWINLOCK KNOTLESS FIXATION DEVICE
K071374 · Arthrocare Corp. · Aug 2007
STRYKER PEEK TWINLOOP TAC
K070882 · Stryker Endoscopy · Jul 2007
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
K071569 · Biomet, Inc. · Jul 2007