Cleared Traditional

K110971 - TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110971 · Navotek Medical, Ltd. · General & Plastic Surgery device
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Jan 2012
Decision
279d
Days
Class 2
Risk

K110971 is an FDA 510(k) clearance for the TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Navotek Medical, Ltd. (Philedelphia, US). The FDA issued a Cleared decision on January 10, 2012 after a review of 279 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.5050 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Navotek Medical, Ltd. devices

Submission Details

510(k) Number K110971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2011
Decision Date January 10, 2012
Days to Decision 279 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 114d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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