Cleared Traditional

K162429 - ZipE Knotless Tissue Repair and Attachm...

K162429 is an FDA 510(k) clearance for ZipE Knotless Tissue Repair and Attachm..., manufactured by Ziptek, LLC. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K162429 · Ziptek, LLC · Orthopedic device
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Mar 2017
Decision
195d
Days
Class 2
Risk

K162429 is an FDA 510(k) clearance for the ZipE Knotless Tissue Repair and Attachment Devices. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Ziptek, LLC (Sarasota, US). The FDA issued a Cleared decision on March 13, 2017 after a review of 195 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ziptek, LLC devices

FDA 510(k) Submission Details - K162429

510(k) Number K162429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2016
Decision Date March 13, 2017
Days to Decision 195 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 122d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 177
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