Cleared Special

K102834 - ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2M...

K102834 is an FDA 510(k) clearance for ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2M..., 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 105-day FDA review.

K102834 · Kinamed, Incorporated · Orthopedic device
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Jan 2011
Decision
105d
Days
Class 2
Risk

K102834 is an FDA 510(k) clearance for the ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER). Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Kinamed, Incorporated (Camarillo, US). The FDA issued a Cleared decision on January 12, 2011 after a review of 105 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. 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. Standard predicate reliance. 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 - K102834

510(k) Number K102834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date January 12, 2011
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 92
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K102834.
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177 · Spinal Elements, Inc. · Jul 2012
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011
K2M COCR WIRE
K103797 · K2m, Inc. · May 2011
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K091190 · Zimmer Spine, Inc. · Jul 2009
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205 · Synthes (Usa) · Jul 2008
BIOMET CABLE SYSTEM
K071271 · Biomet Manufacturing, Inc. · Oct 2007