Cleared Special

K182446 - TruShot with Y-Knot All-Suture Anchor

K182446 is an FDA 510(k) clearance for TruShot with Y-Knot All-Suture Anchor, manufactured by Conmed Corporation. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 103-day FDA review.

K182446 · Conmed Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
103d
Days
Class 2
Risk

K182446 is an FDA 510(k) clearance for the TruShot with Y-Knot All-Suture Anchor. 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 December 19, 2018 after a review of 103 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.

FDA 510(k) Submission Details - K182446

510(k) Number K182446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2018
Decision Date December 19, 2018
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

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 606
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K182446.
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
ICONN Revolution Knotless Suture Anchor
K182264 · Iconn Orthopedics, LLC · Oct 2018
Arthrex FiberTak Suture Anchor
K181769 · Arthrex, Inc. · Sep 2018
Arthrex PushLock Tenodesis Anchor
K181513 · Arthrex, Inc. · Aug 2018
K182446 · TruShot with Y-Knot All-Suture Anchor
Download PDF FDA Summary Conmed Corporation