The InfinityTM Fixation System is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral ligament.

Device Description

The CONMED Infinity™ Fixation System is a family of metal buttons and nonabsorbable Hi-Fi suture for suspensory fixation of tendon to bone used in ligament reconstruction procedures. The Infinity™ Fixation System is provided individually packaged, single-use, sterile. The anchor, suture, and disposable driver are EO Sterilized.

AI/ML Overview

This is a 510(k) summary for a medical device called the "Infinity™ Fixation System," which is intended for soft tissue to bone fixation in ligament reconstruction procedures. The document does not describe acceptance criteria in the way you've outlined for an AI/ML device. Instead, it details performance testing for a traditional medical device (a mechanical fixation system).

Therefore, I cannot provide the specific information you requested in bullet points 1 through 9 because the provided text does not contain information related to AI/ML device acceptance criteria or studies involving AI/ML components.

The document focuses on demonstrating substantial equivalence to a predicate device ("ConMed Linvatec XO Button") for a mechanical device through:

Device Description and Intended Use: Comparing the Infinity™ Fixation System to the predicate device.
Technological Characteristics: Highlighting similarities in how the devices work (e.g., providing suspension fixation, pre-attached sutures).
Performance Data: Listing various types of engineering and biological tests conducted (e.g., Ultimate Fixation Strength, Biocompatibility, Sterilization, Shelf-life) to show the device performs as intended and is safe and effective. These are standard tests for orthopedic fixation devices, not AI/ML performance metrics.

To reiterate, there is no mention of:

A table of acceptance criteria and reported device performance for an AI/ML component.
Sample sizes for test sets related to AI/ML, data provenance, or explicit ground truth establishment methods for an AI/ML model.
Expert involvement for establishing AI/ML ground truth or adjudication methods.
MRMC studies or standalone AI/ML performance.
Training set details for an AI/ML model.

Summary

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ConMed Corporation Orjada Dervishleri Regulatory Affairs Specialist 525 French Road Utica, New York 13502

Re: K191204

Trade/Device Name: InfinityTM Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 21, 2019 Received: June 21, 2019

Dear Orjada Dervishleri:

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

July 3, 2019

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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 medical devices and radiation-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,

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

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name InfinityTM Fixation System

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside, followed by the word "CONMED" in black, with a horizontal line underneath. Below the line, the word "CORPORATION" is written in smaller, gray letters.

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 K191204

I. SUBMITTER

CONMED Corporation 11311 Concept Blvd Largo, Florida 33773

Phone: 727-399-5491 Fax: 727-399-5264

Contact Person: Orjada Dervishleri Date Prepared: May 3rd, 2019

II. DEVICE NAME

Device Name:	Infinity™ Fixation System
Classification Name:	Fastener, fixation, nondegradable, soft tissue
Regulatory Class:	Class II, per 21 CFR Part 888. 3040
Product Codes:	MBI

III. PREDICATE/ LEGALLY MARKET DEVICE

Device Name:	ConMed Linvatec XO Button
Company Name:	ConMed Linvatec
510(k) #:	K070780

IV. PREDICATE DEVICE

Device Name:	GraftMax™ Button, ALB (Adjustable Loop Button) andGraftMax™ Button, BTB (Bone-Tendon-Bone)
Company Name:	ConMed Corporation
510(k) #:	K151037

V. DEVICE DESCRIPTION

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Image /page/4/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue abstract shape on the left, resembling a stylized "C". To the right of the shape is the company name "CONMED" in bold, black letters. Below the company name is the word "CORPORATION" in smaller, lighter font, underlined with a thin blue line.

VI. INTENDED USE/ INDICATIONS FOR USE

VII. The Infinity™ Fixation System is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral collateral ligament.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VIII. PREDICATE DEVICE

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

	InfinityTM Fixation SystemProposed Device	ConMed Linvatec XO ButtonPredicate Device	GraftMax Button, ALB withCradle, GraftMax Button,BTB with CradlePredicate Device
Device Description	The InfinityTM Fixation System is a family ofmetal buttons and non-absorbable Hi-Fisuture for suspensory fixation of soft tissuegrafts to bone used in ligamentreconstruction procedures.	Same	Same
Intended Use /Indication for Use	The InfinityTM Fixation System is intended toprovide suspension fixation for soft tissue tobone in the repair of the natural ligament ortendon disruption or reconstruction of aligament using soft tissue grafts. Examples ofsuch procedures include anterior cruciateligament, posterior cruciate ligament, medialcollateral ligament, and lateral collateralligament.	Same	The device may be used ineither arthroscopic or opensurgical procedures. After thesuture is anchored to the bone,it may be used to reattach softtissue, such as ligaments,tendons, or joint capsules tothe bone. The suture anchorsystem thereby stabilizes thedamaged soft tissue, inconjunction with appropriatepostoperative immobilization,throughout the healing period.
Contraindications	1. Do not use the Infinity™ Fixation Systemfor fixation of bone-patellar tendon-bone(BTB) grafts.2. The Infinity™ Femoral Adjustable LoopButton is contraindicated for fixation ofsoft tissue in the tibial tunnel of ACL andPCL repairs.3. Insufficient quantity or quality of corticalbone for fixation.4. Blood supply limitations and/or previousinfections, which may tend to retardhealing.5. Patients with active sepsis.6. Conditions which tend to limit thepatient's ability or willingness to followdirections during the healing period.7. Foreign body sensitivity, known orsuspected allergies to implant materials.	Same	1.Insufficient quantity orquality of cortical bone forfixation.2.Blood supply limitationsand/or previous infections,which may tend to retardhealing.3.Patients with active sepsis.4.Conditions which tend tolimit the patient's ability orwillingness to followdirections during the healingperiod.5.Foreign body sensitivity,known or suspected allergiesto implant materials.

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Image /page/5/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract shape on the left. To the right of the square is the word "Conmed" in black, with the word "Corporation" in a smaller font size underneath. A thin blue line separates the two words.

Components	Femoral button with pull tabTibial buttons (2)Free loop SutureCradle		Same
TechnologicalCharacteristics	Providing Suspension FixationPre-attached with suturesLead strand suture to manipulate and positionthe button but not implantedAdjustable Loop techniqueFree LoopAdaptor for the button body	Providing SuspensionFixationPre-attached with suturesFixed Loop technique	Providing SuspensionFixationPre-attached with suturesAdaptor for the buttonbody

IX. PERFORMANCE DATA

Testing has been completed to demonstrate that the Infinity™ Fixation System 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

Reliability ●
Ultimate Fixation Strength ●
Transportation ●
Cyclic
Pyrogen ●
Biocompatibility ●
Shelf-life ●

Validation Testing

User Validation ●
Packaging ●
Labeling ●
Sterilization ●
X. CONCLUSION
The Infinity™ Fixation System is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed Linvatec XO Button. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the Infinity™ Fixation System is substantially equivalent to the ConMed Linvatec XO Button (K070780).

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.