The CONMED MicroLink™ All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-issue-to-bone, is intended as a fixation post, distributing suture tension over areas of ligament or tendon repair.

The CONMED MicroLink All-Suture Button Fixation System is indicated for fixation of bone-to-bone as an adjunct in the following orthopedic surgical procedures:
Procedure: Carpometacarpal Suspension
Anatomic Location: Hand

Device Description

The MicroLink™ All-Suture Button Fixation System (Radiolucent) is an all-suture suspension device with one strand of #2 (5 metric) Hi-Fi® suture, a radiolucent flat braid Hi-Fi® Suture Button and a radiolucent flat braid Hi-Fi® suture Backstop threaded on a Loader. A suture passing drill is provided with a nitinol loop for passing. A trapezium pin is provided to facilitate manipulation of the trapezium during trapeziectomy. All four catalog numbers are provided sterile, intended for single-use.

AI/ML Overview

The provided text does not contain information about acceptance criteria and the study that proves the device meets them in the format requested. The document is a 510(k) summary for the CONMED MicroLink™ All-Suture Button Fixation System (Radiolucent), which focuses on demonstrating substantial equivalence to a predicate device.

While it mentions "PERFORMANCE DATA" and lists types of testing conducted (e.g., Ultimate Fixation Strength, Cyclic Shear Testing, Biocompatibility), it does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets or training sets.
Data provenance (country of origin, retrospective/prospective).
Number and qualifications of experts to establish ground truth.
Adjudication method.
Details of a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Standalone algorithm performance.
Type of ground truth used (expert consensus, pathology, outcomes data).
How ground truth for the training set was established.

The document primarily focuses on a comparison of technological characteristics with a predicate device (CMC Mini TightRope) and concludes substantial equivalence based on design, materials, intended use, principles of operation, and technical characteristics, supported by verification and validation testing. However, the specific results against defined acceptance criteria are not detailed in this summary.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CONMED Corporation Diana Nader-Martone Senior Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773

Re: K190516

Trade/Device Name: MicroLinkTM All-Suture Button Fixation System (Radiolucent) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: May 28, 2019 Received: May 29, 2019

Dear Ms. Nader-Martone:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

{1}------------------------------------------------

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K190516

Device Name MicroLink™M All-Suture Button Fixation System (Radiolucent)

Indications for Use (Describe)

Intended Use

The CONMED MicroLink™ All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-issue-tobone, is intended as a fixation post, distributing suture tension over areas of ligament or tendon repair.

Indications for Use

The CONMED MicroLink All-Suture Button Fixation System is indicated for fixation of bone-to-bone as an adjunct in the following orthopedic surgical procedures:

Procedure Anatomic Location Carpometacarpal Suspension Hand

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a stylized blue and white graphic on the left, resembling a wave or abstract shape. To the right of the graphic is the company name "CONMED" in a bold, sans-serif font, with a blue line underneath. Below the line, the word "CORPORATION" is printed in a smaller, sans-serif font.

510(k) SUMMARY

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CONMED Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number _K190516

I. SUBMITTER

CONMED Corporation 11311 Concept Blvd Largo, Florida 33773

Phone: 727-399-5425 Fax: 727-399-5264

Contact Persons: Diana L. Nader-Martone or Kathy Reddig Date Prepared: May 28, 2019

II. DEVICE NAME

Device Name:	MicroLink™ All-Suture Button Fixation System(Radiolucent)
Common Name:	Nonabsorbable Suture Fixation System
Classification Name:	Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class:	Class II, per 21 CFR Part 888. 3030
Product Codes:	HTN

III. PREDICATE/ LEGALLY MARKET DEVICE

Device Name:	CMC Mini TightRope
Company Name:	Arthrex, Inc.
510(k) #:	K140328

IV. DEVICE DESCRIPTION

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract shape inside on the left. To the right of the square is the word "CONMED" in black, with a horizontal line underneath. Below the line is the word "CORPORATION" in smaller, gray letters.

INTENDED USE/ INDICATIONS FOR USE V.

The CONMED MicroLink™ All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.

The CONMED MicroLink™ All-Suture Button Fixation System is indicated for fixation of bone-to-bone as an adjunct in the following orthopedic surgical procedures:

Procedure	Anatomic Location
Carpometacarpal Suspension	Hand

COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE

The following table represents a summary of the technological characteristics between the proposed and the predicate device.

	MicroLinkTM All-Suture Button Fixation System	CMC Mini TightRope
	(Radiolucent)	Predicate Device
	Proposed Device
Device	The MicroLink™ All-Suture Button Fixation
Description	System (Radiolucent) is an all-suture suspension
	device with one strand of #2 (5 metric) Hi-Fi®
	suture, a radiolucent flat braid Hi-Fi® Suture
	Button and a radiolucent flat braid Hi-Fi® suture
	Backstop threaded on a Loader. A suture passing
	drill is provided with a nitinol loop for passing.
	A trapezium pin is provided to facilitate
	manipulation of the trapezium during
	trapeziectomy. All four catalog numbers are
	provided sterile, intended for single-use.
Intended Use	The CONMED MicroLink™ All-Suture Button
	Fixation System, when used for fixation of bone-
	to-bone or soft-tissue-to-bone, is intended as a	Same
	fixation post, distribution bridge, or for
	distributing suture tension over areas of ligament
	or tendon repair.
Indication for Use	The CONMED MicroLink™ All-Suture Button	Specifically, the Arthrex CMC Mini TightRope is
	Fixation System is indicated for fixation of bone-	indicated for Carpal Metacarpal (CMC) joint
	to-bone as an adjunct in the following	arthroplasty as an adjunct in the suspension of the thumb
	orthopedic surgical procedures:	metacarpal during the healing process of hematoma
	ProcedureAnatomic Location	distraction arthroplasty by providing stabilization at the
	Carpometacarpal Suspension Hand	base of the first and second metacarpal when the
		trapezium has been excised due to osteoarthritis.
Contraindications	1.Pathological conditions of bone which	Insufficient quantity or quality of bone.1.
	would adversely affect the device.	Blood supply limitations and previous infections,2.
	2.Physical conditions that would eliminate, or	which may retard healing.
	tend to eliminate, adequate implant support	Foreign body sensitivity. Where material sensitivity3.
	or retard healing.	is suspected, appropriate tests should be made and
	3.Conditions which tend to limit the patient's	sensitivity ruled out prior to implantation.
	ability or willingness to restrict activities or	Foreign Body Reactions. See Adverse Effects-4.
	follow directions during the healing period.	Allergic Type Reactions.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, stylized "C" shape inside. To the right of the square, the word "CONMED" is written in a bold, black sans-serif font. Below "CONMED", the word "CORPORATION" is written in a smaller, lighter font, with a blue line above it.

	MicroLink™ All-Suture Button Fixation System(Radiolucent)Proposed Device	CMC Mini TightRopePredicate Device
	4. Attachment of artificial ligaments or otherimplants.5. Foreign body sensitivity, known orsuspected allergies to implant and/ orinstrument materials.6. This device is not approved for screwattachment or fixation to the posteriorelements (pedicles) of the cervical,thoracic or lumbar spine.7.8. Patients with active sepsis or infection.	5. Any active infection or blood supply limitations.6. Conditions which tend to limit the patient's abilityor willingness to restrict activities or followdirections during the healing period.7. The use of this device may not be suitable forpatients with insufficient or immature bone. Thephysician should carefully assess bone qualitybefore performing orthopedic surgery on patientswho are skeletally immature. The use of this medicaldevice and the placement of hardware or implantsmust not bridge, disturb, or disrupt the growth plate.8. Do not use for surgeries other than those indicated.
Components	All-Suture Button (Radiolucent) with sutureAll-Suture BackstopLoaderTrapezium PinSuture Passing Drill	TightRope Suture Construct with sutureOblong Button for Mini TightRopeLoaderTrapeziectomy Tool w/ HandleSuture Passing K-wire, shortSuture Passing K-wire, longSuture Passing Wire, 8 inches
TechnologicalCharacteristics	Flat-braid suture buttonFlat-braid suture backstopOne #2 sutureRadiolucent implantSuture Passing Drill to pull suture through one ormore bonesInstrument to maneuver and remove boneMR Safe	Stainless steel buttonStainless steel backstopOne #2 sutureRadiopaque implantSuture passing drill to pull suture through one or morebonesInstrument to maneuver and remove bone

VIII. PERFORMANCE DATA

Testing has been completed to demonstrate that the MicroLinkTM All-Suture Button Fixation System (Radiolucent) performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits.

Completed testing includes the following:

Verification Testing Sterilization

Reliability
Side-by-Side Testing
Pyrogen ●
●
Ultimate Fixation Strength ● ● Cyclic
●
Biocompatibility Shelf-life ●
Shear Testing

Validation Testing

User Validation ●
Packaging
Transportation
IX. CONCLUSION
The MicroLink™ All-Suture Button Fixation System (Radiolucent) is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate CMC Mini TightRope. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy,

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue "C" shape on the left, followed by the word "CONMED" in bold, black letters. Below "CONMED" is the word "CORPORATION" in smaller, black letters.

and the MicroLink™ All-Suture Button Fixation System (Radiolucent) is substantially equivalent to the CMC Mini TightRope (K140328).

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.