CONMED LINVATEC XO BUTTON

K070780 · Conmed Linvatec · MBI · Aug 21, 2007 · Orthopedic

Device Facts

• Record ID: K070780
• Device Name: CONMED LINVATEC XO BUTTON
• Applicant: Conmed Linvatec
• Product Code: MBI · Orthopedic
• Decision Date: Aug 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 liqament, 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 Story

Sterile, single-use titanium (TI-6AL-4V-ELI) implant for orthopedic soft tissue-to-bone fixation. Device consists of a metal button, available with or without a continuous loop (10-60mm). Used by surgeons in clinical settings for ligament/tendon reconstruction procedures (e.g., ACL, PCL, biceps tendon). Implant provides suspension fixation, securing grafts to bone to facilitate healing and restore joint stability. Benefits include reliable mechanical fixation during the healing process.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Titanium (TI-6AL-4V-ELI). Dimensions: 12-18mm length, 4.5mm width. Continuous loop: 10-60mm. Principle: Mechanical suspension fixation. Sterile, single-use.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation during ligament or tendon repair/reconstruction, including ACL, PCL, MCL, LCL, distal biceps tendon rupture, and coracoclavicular ligament disruptions.

Regulatory Classification

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.

Predicate Devices

• Endobutton Continuous Loop (K980155)
• RetroButton (K062747)
• Tightrope Acromioclavicular (AC) Device (K052776)

Submission Summary (Full Text)

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

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 [phone] Telephone [phone] FAX

#### C. Device Name

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

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

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

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.

### F. Intended Use - XO Button with 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. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral liqament, and lateral collateral ligament.

#### 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.

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

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.

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

# 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.

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

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 [phone]. 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 [phone] or [phone] 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

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

# Indications for Use

510(k) Number (if known): __K070780___________________________________________________________________________________________________________________________________________

Device Name: __ConMed Linvatec XO Button™ without Continuous Loop_____________________________________________________________________________________________________________

Indications for Use:

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.

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_

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

# Indications for Use

510(k) Number (if known): __K070780___________________________________________________________________________________________________________________________________________

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

Indications for Use:

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.

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