HAMMERTOE CORRECTION SYSTEM

K130859 · Arthrosurface, Inc. · HWC · Jul 25, 2013 · Orthopedic

Device Facts

• Record ID: K130859
• Device Name: HAMMERTOE CORRECTION SYSTEM
• Applicant: Arthrosurface, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

Device Story

Hammertoe Correction System consists of two intramedullary bone screws and a taper lock pin; used for small bone fusion, fractures, and inter-digital fusion of fingers and toes. System includes specialized instruments for implant site preparation and delivery. Taper lock pin creates press-fit connection between screws with light contact pressure. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical fixation to stabilize bone segments, facilitating fusion and healing. Implant components manufactured from titanium alloy and cobalt-chrome alloy.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic cantilever bending, torque to failure, pull-out force, insertion-removal torque, and axial disassembly force tests. Comparative dimensional analyses and cadaveric testing were also performed to support equivalence.

Technological Characteristics

Materials: Implant-grade titanium alloy and cobalt-chrome alloy. Components: Two intramedullary bone screws, taper lock pin. Mechanism: Taper lock pin provides press-fit connection with light contact pressure. Form factor: Small bone fixation hardware. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring small bone fusion, fracture fixation, or inter-digital fusion of fingers, toes, and small bones.

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

• FlexFusion™ Fixation Implant (K110445)
• PRO-TOE™ VO Hammertoe Implant System (K101165)

Reference Devices

• StayFuse (K990804)

Submission Summary (Full Text)

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#### Section 5 510(k) Summary

| 510(k) Owner: | Arthrosurface, Inc.<br>28 Forge Parkway<br>Franklin, MA 02038<br>Tel: [phone]<br>Fax: [phone]<br>JUL 2 5 2013 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Wilson<br>VP, Quality & Regulatory |
| Date of Preparation: | March 26, 2013 |
| Trade Name: | Hammertoe Correction System |
| Common Name: | Intramedullary Bone Screw |
| Device: | Screw, Fixation, Bone |
| Regulation Description: | Smooth or threaded metallic bone fixation<br>fastener |
| Regulation Number: | 888.3040 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | HWC |

### Intended Use

Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

### Device Description

The Arthrosurface Inc's Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The taper lock pin provides a press fit connection between the two screws with light contact pressure. The implant components are manufactured using implant grade titanium alloy and cobaltchrome alloy.

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## Substantial Equivalency

The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices:

| • Nextremity Solutions, LLC<br>FlexFusion™ Fixation Implant | K110445 |
|---------------------------------------------------------------------------|---------|
| • Wright Medical Technology, Inc.<br>PRO-TOE™ VO Hammertoe Implant System | K101165 |

- K990804 Tornier, Inc. . . StayFuse
Comparative Mechanical Testing was performed per relevant recognized standards. Results from static and dynamic cantilever bending, torque to failure, pull-out force, insertion-removal torque and axial disassembly force tests along with comparative dimensional analyses were used to support equivalence to predicate devices. Data from cadaveric testing were also reported.

The fundamental scientific technology of the proposed device has not changed relative to the predicate devices.

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized symbol that resembles an abstract human figure.

Public Health Service

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

July 25, 2013

Arthrosurface, Incorporated % Ms. Dawn Wilson Vice President, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038

Re: K130859

Trade/Device Name: Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 6, 2013 Received: June 11, 2013

Dear Ms. Wilson:

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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Page 2 - Ms. Dawn Wilson

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Erin I. Keith

For

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

Enclosure

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Section 4 Indications for Use Statement \$ 1

510(k) Number (if known): _K130859

Device Name: Hammertoe Correction System

Indications for Use:

Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | ________________________________ |
|-------------------------------------------------|----------------------------------|
|-------------------------------------------------|----------------------------------|

AND/OR

| Over-The-Counter<br>(21 CFR 8) | |
|--------------------------------|--|
|--------------------------------|--|

Counter Use 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Lori A. Wiggins

Division of Orthopedic Devices

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