GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle

K151037 · Conmed Corporation · MBI · Jul 9, 2015 · Orthopedic

Device Facts

• Record ID: K151037
• Device Name: GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
• Applicant: Conmed Corporation
• Product Code: MBI · Orthopedic
• Decision Date: Jul 9, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device 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, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.

Device Story

GraftMax™ Button (ALB and BTB versions) with Cradle are sterile, single-use titanium alloy fixation devices. Used by orthopedic surgeons in clinical settings for ligament/tendon repair and reconstruction. Devices consist of an oval-shaped button and cradle (21mm x 6mm) with five suture holes. Function as mechanical fasteners to provide suspension fixation of soft tissue grafts to bone. Benefit includes secure graft attachment during surgical procedures. No software or electronic components involved.

Clinical Evidence

Bench testing only. Performance data includes reliability, packaging, ultimate fixation strength, cyclic testing, sterilization verification, transportation, biocompatibility, user validation, and shelf-life testing.

Technological Characteristics

Titanium alloy construction; oval-shaped button and cradle; 21mm x 6mm dimensions; five suture holes; sterile, single-use; Gamma sterilization for implant, EtO for cradle.

Indications for Use

Indicated for patients requiring soft tissue-to-bone suspension fixation for ligament or tendon repair/reconstruction, including ACL, PCL, MCL, LCL, distal biceps tendon, 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

• GraftMax™ Button, ALB (Adjustable Loop Button) and GraftMax™ Button, BTB (Bone-Tendon-Bone) (K070780)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 9, 2015

CONMED Corporation Ms. Nyrobia Freeman Regulatory Affairs Specialist 525 French Road Utica, New York 11502

Re: K151037

Trade/Device Name: GraftMax™ Button, ALB with Cradle and GraftMax™ Button, BTB with Cradle Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Class: Class II Product Code: MBI Dated: June 5, 2015 Received: June 10, 2015

Dear Ms. Freeman:

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

### K151037

Device Name

GraftMax™ Button, ALB with Cradle GraftMax™ Button, BTB with Cradle

### Indications for Use (Describe)

The device 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, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.

| Type of Use (Select one or both, as applicable) | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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Image /page/3/Picture/0 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 smaller blue letters underneath. The logo is simple and modern, and the colors are clean and professional.

## 510(k) SUMMARY

#### I. SUBMITTER

CONMED Corporation 525 French Road Utica, New York Phone: [phone] Fax: [phone] Date Prepared: June 26, 2015

Company Contact

Nyrobia Freeman Regulatory Affairs Specialist Telephone [phone] Fax [phone]

#### II. DEVICE

| Trade of Device: | GraftMax™ Button, ALB (Adjustable Loop Button) with<br>Cradle and GraftMax™ Button, BTB (Bone-Tendon-Bone)<br>with Cradle |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Titanium Fixation Device |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft-Tissue |
| Regulatory Class: | Class II |
| Product Codes: | MBI |
| Regulation: | 21 CFR Part 888. 3040 |

#### III. PREDICATE DEVICE

| Device Name: | GraftMax™ Button, ALB (Adjustable Loop Button) and<br>GraftMax™ Button, BTB (Bone-Tendon-Bone) |
|---------------|------------------------------------------------------------------------------------------------|
| Company Name: | CONMED Corporation |
| 510(k) #: | K070780 |

#### IV. DEVICE DESCRIPTION

The GraftMax™ Button, ALB (Adjustable Loop Button) with Button Cradle and GraftMax™ Button, BTB (Bone-Tendon-Bone) with Button Cradle are sterile, single use devices. The button and cradle used together measure 21mm in length and 6mm in width. The devices are oval shaped and manufactured of titanium alloy. The devices are designed with five (5) holes that sutures can be threaded through.

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Image /page/4/Picture/0 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 blue line underneath. Below the line is the word "CORPORATION" in smaller, black letters.

#### V. INDICATIONS FOR USE

The device 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.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The GraftMax™ Button ALB with Cradle, and the GraftMax™ Button BTB, with Cradle are identical in intended use and principles of operation to the predicate device with exceptions of dimensions, sterilization and packaging.

| | Proposed Device | Predicate Device |
|---------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Dimensions | 21mm x 6mm | 14mm x 4.5mm |
| Sterilization | Implant- Gamma<br>Cradle- EtO | Implant - Gamma |
| | | |
| Packaging | Implant - Sterile, single use<br>package<br>Cradle – Sterile, single use<br>package , packaged<br>separately | Implant- Sterile, single use<br>package |
| | | |
| | | |
| | | |

## VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Completed testing includes the following:

- Reliability ●
- Packaging ●
- Ultimate Fixation Strength ●
- Cyclic ●
- Sterilization
- Verification Testing ●
- . Transportation
- Biocompatibility ●
- User Validation ●
- Shelf-life

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Image /page/5/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square on the left side with a white, curved shape inside. To the right of the square is the word "Conmed" in black, sans-serif font. Below the word "Conmed" is the word "Corporation" in a smaller, sans-serif font, also in black.

## VIII. CONCLUSION

The GraftMax™ Button ALB with Cradle, and the GraftMax™ Button BTB, with Cradle are substantially equivalent in design, manufacturing materials, intended use, principles of operation to the predicate GraftMax™ Button ALB, and GraftMax™ Button, BTB and raises no new issues of safety or effectiveness.