The XO Button with continuos loop 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.

The XO Button without continuos loop 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 or bone tendon grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.

Device Description

The ConMed Linvatec XO Button™ is a sterile, single use, implant for fixation of soft tissue to bone in orthopedic procedures. The XO Button™ is designed with both a continuous loop for fixation of soft tissue to bone and without a continuous loop. The body of the implant is composed of titanium (TI-6AL-4V-ELI) with the following dimensions: length from12 to 18mm and width 4.5 ± .1mm. The continuous loop ranges in size from 10 to 60mm.

AI/ML Overview

Here's an analysis of the provided text regarding the ConMed Linvatec XO Button™:

Based on the provided 510(k) summary for the ConMed Linvatec XO Button™, it appears no specific acceptance criteria or a study demonstrating the device meets those criteria are included in this document.

This 510(k) submission is for a medical device that gains market clearance through a demonstration of substantial equivalence to existing legally marketed predicate devices, rather than through meeting specific performance criteria established by clinical studies for novel devices.

Therefore, many of the requested categories of information cannot be extracted from this document, as they are not relevant to a 510(k) substantial equivalence determination.

Here's a breakdown of what can be inferred or explicitly stated from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not applicable. The 510(k) summary does not define specific performance acceptance criteria for the XO Button™.	Not applicable. No specific performance data or a study to meet such criteria is presented. The device's clearance is based on substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The 510(k) summary does not mention a "test set" in the context of performance testing for the XO Button™. The determination is based on comparison to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There is no mention of a "test set" and thus no ground truth established by experts for performance evaluation of the XO Button™ itself.

4. Adjudication Method for the Test Set:

Not applicable. No test set or related adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:

No. This document does not describe an MRMC comparative effectiveness study. The medical device in question (a fixation button) is unlikely to be evaluated using MRMC studies, which are typically for diagnostic imaging devices where human interpretation is a key component.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No. This device is a surgical implant, not an algorithm, so this concept is not applicable.

7. The Type of Ground Truth Used:

Not applicable. For a substantial equivalence submission, the "ground truth" is effectively the established safety and effectiveness of the predicate devices. The new device is compared to these predicates.

8. The Sample Size for the Training Set:

Not applicable. The device is not an AI/ML algorithm or a diagnostic tool that would require a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, no training set or ground truth establishment for a training set is relevant to this device's submission.

Summary of the Study that "Proves" the Device Meets Acceptance Criteria (in the context of a 510(k)):

The "study" or evidence used in this 510(k) is a comparison study demonstrating substantial equivalence to legally marketed predicate devices. The ConMed Linvatec XO Button™ is deemed substantially equivalent to the following:

Endobutton Continuous Loop (Smith and Nephew, K980155)
RetroButton (Arthrex, K062747)
Tightrope Acromioclavicular (AC) Device (Arthrex, K052776)

The justification for substantial equivalence is based on similarities in:

Intended Use: The XO Button™ (with and without continuous loop) has intended uses that align with soft tissue to bone fixation for ligament/tendon repair or reconstruction, similar to the predicates.
Technology/Design: The XO Button™, Endobutton Continuous Loop, and RetroButton have similar designs and are used for fixating soft tissue ligaments. They share similar components and suture lengths. The XO Button™ and the TightRope Acromioclavicular (AC) Device have similar indications and design, with the primary difference being the XO Button™ only involves one sized metal button.
Materials: The body of the implant is composed of titanium (TI-6AL-4V-ELI), which is a common material for such implants.
Sterility and Usage: All are sterile, single-use devices.

The submission states that "Any differences between the XO Button™ and the identified predicate devices are considered minor and do not raise questions concerning safety and effectiveness."

This type of submission does not involve clinical trials or performance studies against predefined acceptance criteria for the new device, but rather a direct comparison to already cleared devices based on their established safety and effectiveness.

Summary

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K070780

510(k) Summary ConMed Linvatec XO Button™ July 28, 2007

AUG 2 1 2007

5. 510(k) SUMMARY ConMed Linvatec XO Button™

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

A. Submitter

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

B. Company Contact

Elizabeth M. Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name:	Conmed Linvatec XO Button™
Common Name:	Titanium Fixation Device
Classification Name:	888.3040 – Fastener, Fixation, Non-degradable, soft-tissue
	888.3030 – Plate, Fixation, Bone
	888.5000 – Suture, non-absorbable,synthetic, polyethylene
	888.3030– Washer, Bolt Nut
Proposed Class/Device:	Class II
Product Code:	MBI, HRS, GAT, HTN

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510(k) Summary ConMed Linvatec XO Button ™ July 28, 2007

D. Predicate/Legally Marketed Devices

The predicate/legally marketed devices for the XO Button™ are:

Device name: Company name: 510(k) #:

Endobutton Continuous Loop Smith and Nephew K980155

Device name: Company name: 510(k) #:

RetroButton Arthrex K062747

Device name:

Company name: 510(k) #:

Tightrope Acromioclavicular (AC) Device Arthrex K052776

E. Device Description

F. Intended Use - XO Button with Continuous Loop

Intended Use - XO Button without Continuous Loop

The XO Button with continuos loop 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 or bone tendon grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.

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510(k) Summary ConMed Linvatec XO Button™ July 28, 2007

G. Substantial Equivalence

The XO Button™ is substantially equivalent in scientific technology, design and intended use to the Smith and Nephew Endobutton, the Arthrex RetroButton and the Arthrex Tightrope Acromioclavicular (AC) Device. The Endobutton was cleared by FDA under 510(k) K980155. The RetroButton was cleared by FDA under 510(k) K062747 and the Tightrope Acromioclavicular (AC) Device under 510(k) K052776.

The XO Button™, the EndoButton Continuous Loop, the RetroButton have similar designs. All are used in fixating soft tissue ligaments. The components are similar. The suture lengths are similar. All are single-use devices. The XO Button™ and the TightRope Acromioclavicular (AC) Device have similar indications for use and design except that the XO Button™ involves only one sized metal button.

Any differences between the XO Button™ and the identified predicate devices are considered minor and do not raise questions concerning safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The bird is positioned to the right of the text, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ConMed Linvatec % Ms. Elizabeth M. Paul Manager, Regulatory Affairs 13111 Concept Boulevard Largo, FL 33773-4908

AUG 2 1 2007

Re: K070780

Trade/Device Name: Conmed Linvatec XO Button™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, GAT Dated: August 6, 2007 Received: August 9, 2007

Dear Ms. Paul:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Elizabeth M. Paul

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Buell

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K070780_________________________________________________________________________________________________________________________________________

Device Name: ConMed Linvatec XO Button™ without Continuous Loop___________________________________________________________________________________________________________

Indications for Use:

Prescription Use _ イ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ 1_ of 1

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Indications for Use

510(k) Number (if known): K070780_________________________________________________________________________________________________________________________________________

Device Name: __ ConMed Linvatec XO Button™ with Continuous Loop____

Indications for Use:

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pavane Buett

Page 1 of 1

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number 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.