Cleared Traditional

K190516 - MicroLink All-Suture Button Fixation Sy...

K190516 is the FDA 510(k) clearance for MicroLink All-Suture Button Fixation Sy... by Conmed Corporation. It is a Class 2 Orthopedic device (product code HTN) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K190516 · Conmed Corporation · Orthopedic device
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Jun 2019
Decision
116d
Days
Class 2
Risk

K190516 is an FDA 510(k) clearance for the MicroLink All-Suture Button Fixation System (Radiolucent). Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on June 28, 2019 after a review of 116 days - within the typical 510(k) review window.

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 Conmed Corporation devices

Submission Details

510(k) Number K190516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date June 28, 2019
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTN Washer, Bolt Nut
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 - HTN Washer, Bolt Nut

All 65
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K190516.
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
K201522 · Arthrex, Inc. · Sep 2020
Akros Scruture Anchor LisFranc Repair Kit
K200361 · Akros Medical · Apr 2020
LARS AC Band Device
K190143 · Corin USA · Nov 2019
MicroLink All-Suture Button Fixation System (Radiopaque)
K190582 · Conmed Corporation · Jun 2019
CyclaPlex Correction System
K183094 · Cycla Orthopedics, Ltd. · Apr 2019
Double ENDOBUTTON Fixation Device
K183232 · Smith and Nephew, Inc. · Mar 2019