Cleared Special

K182621 - CrossFT Knotless Deep Thread Suture Anc...

K182621 is the FDA 510(k) clearance for CrossFT Knotless Deep Thread Suture Anc... by Conmed Corporation. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 102-day FDA review.

K182621 · Conmed Corporation · Orthopedic device
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Jan 2019
Decision
102d
Days
Class 2
Risk

K182621 is an FDA 510(k) clearance for the CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on January 4, 2019 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Conmed Corporation devices

Submission Details

510(k) Number K182621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date January 04, 2019
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 414
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K182621.
TenoTac Soft Tissue Fixation System
K182898 · Paragon 28, Inc. · Jan 2019
Cortical Fixation Systems
K181086 · Cousin Biotech Sas · Jan 2019
TruShot with Y-Knot Shallow All-Suture Anchor
K182439 · Conmed Corporation · Jan 2019
Responsive Arthroscopy Suture Anchor System
K180951 · Responsive Arthroscopy, LLC · Jan 2019
OIC Suture Anchor System
K182736 · The Orthopaedic Implant Company · Dec 2018
2.8 mm/3.3 mm PopLok Suture Anchors
K181120 · Conmed Corporation · Dec 2018