Cleared Special

K181749 - SuperCable Iso-Elastic Cerclage System

K181749 is an FDA 510(k) clearance for SuperCable Iso-Elastic Cerclage System, manufactured by Kinamed, Incorporated. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K181749 · Kinamed, Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
30d
Days
Class 2
Risk

K181749 is an FDA 510(k) clearance for the SuperCable® Iso-Elastic™ Cerclage System. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Kinamed, Incorporated (Camarillo, US). The FDA issued a Cleared decision on August 1, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Kinamed, Incorporated devices

FDA 510(k) Submission Details - K181749

510(k) Number K181749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2018
Decision Date August 01, 2018
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 91
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K181749.
Tritium Sternal Cable Plate System
K193468 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Mar 2020
Thorecon Rigid Fixation System
K181607 · A & E Medical Corporation · Oct 2018
Impress SFS System
K173910 · Cable Fix Medical, LLC · Sep 2018
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
K172975 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Jun 2018
Sternal Cable System
K180582 · A & E Medical Corporation · May 2018
Thorecon™ Fixation System
K173579 · A & E Medical Corporation · Feb 2018