Arthrosurface Bone Screws

K161539 · Arthrosurface, Inc. · HWC · Jun 30, 2016 · Orthopedic

Device Facts

• Record ID: K161539
• Device Name: Arthrosurface Bone Screws
• Applicant: Arthrosurface, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 30, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

Device Story

Arthrosurface Bone Screws are metallic fixation fasteners used by orthopedic surgeons for small bone procedures. Available in 2.0/2.7 mm diameters and 8-24 mm lengths, these screws feature a snap-off design for ease of use with powered wire drivers. Manufactured from implant-grade stainless steel or titanium alloy, they provide mechanical stabilization of bone segments during healing. The device is used in clinical settings for fracture repair, osteotomies, and arthrodesis. Surgeons select appropriate screw lengths to achieve fixation, with the snap-off feature facilitating precise placement. The device benefits patients by providing secure bone stabilization, promoting proper healing, and enabling surgical correction of small bone deformities or injuries.

Clinical Evidence

Bench testing only. Comparative analyses were performed to demonstrate equivalence to predicate devices. Non-clinical testing included a Kinetic Chromogenic LAL test to confirm the device is non-pyrogenic.

Technological Characteristics

Metallic bone fixation fasteners; 2.0/2.7 mm diameter; 8-24 mm lengths; snap-off feature; materials: implant-grade stainless steel or titanium alloy; compatible with powered wire drivers; sterilized using standard processes.

Indications for Use

Indicated for patients requiring fracture fixation, osteotomies, reconstruction, revision surgery, or arthrodesis of small bones in upper and lower extremities.

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

• CheckMate® Small Bone Fusion System (K122334)
• Pinlt® Small Bone Fusion System (K140617)

Reference Devices

• Merete TwistCut™ Snap-Off Bone Screw (K051323)

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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a group of people in profile. The logo is black and white.

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

June 30, 2016

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

Re: K161539

Trade/Device Name: Arthrosurface Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 2, 2016 Received: June 3, 2016

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 Parts 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/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/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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#### Section 4 Indications for Use Statement

510(k) Number (if known): __K161539

Device Name: Arthrosurface Bone Screws

### Indications for Use:

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

## Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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#### Section 5 510(k) Summary

# Special 510(k): Device Modification

| 510(k) Owner: | Arthrosurface, Inc.<br>28 Forge Parkway<br>Franklin, MA 02038<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Wilson<br>VP, Quality & Regulatory<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Establishment Registration<br>Number: | 3004154314 |
| Date of Preparation: | June 24, 2016 |
| Confidentiality: | Reference Section 3 |
| Proprietary Name: | Arthrosurface Bone Screws |
| Common Name: | Bone Screws |
| 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 |

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## Intended Use

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

## Device Description

The Arthrosurface Bone Screws have a diameter of 2.0/2.7 mm and are made available in lengths varying from 8 mm to 24 mm with 2 mm increments. The bone screws have a snap-off feature and are designed to work with a powered wire driver, and are manufactured from implant grade stainless steel or titanium allov.

## Substantial Equivalence Information

Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Arthrosurface Bone Screws are substantially equivalent in indications and design principles to the following predicate and/or reference devices, which have been previously cleared by the FDA:

Primary Predicate

CheckMate® Small Bone Fusion System (K122334, Cleared on 11/28/2012)

Additional Predicate(s)

Pinlt® Small Bone Fusion System (K140617, Cleared on 04/25/2012)

Reference Device(s)

Merete TwistCut™ Snap-Off Bone Screw (K051323, Cleared on 07/07/2005)

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

- Has the same Indications for Use, .
- Uses the same operating principle, ●
- . Is manufactured using common orthopedic implant materials – Stainless Steel and Titanium alloy,
- Utilizes the same instrumentation for proper placement, .
- Is packaged and sterilized using the same materials and processes. ●

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In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:

- Device Comparative Analyses
- A Kinetic Chromogenic LAL Test for Devices was used to determine the device is non-pyrogenic.

The results have demonstrated that the Arthrosurface Bone Screws are substantially equivalent to the predicate devices.