Cleared Traditional

K190516 - MicroLink All-Suture Button Fixation System (Radiolucent)

K190516 is an FDA 510(k) clearance for MicroLink All-Suture Button Fixation Sy..., manufactured by Conmed Corporation. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K190516

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.

HTN Device Classification - Class 2, Special Controls

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 86
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