Cleared Traditional

K182439 - TruShot with Y-Knot Shallow All-Suture Anchor

K182439 is an FDA 510(k) clearance for TruShot with Y-Knot Shallow All-Suture ..., manufactured by Conmed Corporation. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K182439 · Conmed Corporation · Orthopedic device
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Jan 2019
Decision
123d
Days
Class 2
Risk

K182439 is an FDA 510(k) clearance for the TruShot with Y-Knot Shallow 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 January 8, 2019 after a review of 123 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. 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 Conmed Corporation devices

FDA 510(k) Submission Details - K182439

510(k) Number K182439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2018
Decision Date January 08, 2019
Days to Decision 123 days
Submission Type Traditional
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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 567
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K182439.
Responsive Arthroscopy Wedge Push-In Suture Anchors
K181076 · Responsive Arthroscopy, LLC · Jan 2019
TenoTac Soft Tissue Fixation System
K182898 · Paragon 28, Inc. · Jan 2019
Cortical Fixation Systems
K181086 · Cousin Biotech Sas · Jan 2019
CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver
K182621 · 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