Cleared Special

K102834 - ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

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 128
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