Cleared Special

K170501 - CrossFT Knotless Biocomposite Suture An...

K170501 is the FDA 510(k) clearance for CrossFT Knotless Biocomposite Suture An... by Conmed Corporation. It is a Class 2 Orthopedic device (product code MAI) cleared through the Special 510(k) pathway after a 24-day FDA review.

K170501 · Conmed Corporation · Orthopedic device
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Mar 2017
Decision
24d
Days
Class 2
Risk

K170501 is an FDA 510(k) clearance for the CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on March 17, 2017 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Conmed Corporation devices

Submission Details

510(k) Number K170501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2017
Decision Date March 17, 2017
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 163
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K170501.
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver
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K151105 · Smith & Nephew, Inc. · Jul 2015