RESTORE BUNION CORRECTION SYSTEM

K131061 · Nextremity Solutions · JDR · Aug 28, 2013 · Orthopedic

Device Facts

• Record ID: K131061
• Device Name: RESTORE BUNION CORRECTION SYSTEM
• Applicant: Nextremity Solutions
• Product Code: JDR · Orthopedic
• Decision Date: Aug 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Restore™ Fixation System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

Device Story

Restore™ Fixation System comprises compression staple and non-locking cortical screws; includes surgical site preparation and insertion instruments. Used by surgeons for small bone fixation in foot and ankle procedures; facilitates bone alignment, stabilization, and fusion. Devices are implanted to provide mechanical support during healing. Pre-packaged sterile for clinical use.

Clinical Evidence

Bench testing only. Mechanical testing performed per recognized standards: 4-point bending (static and dynamic) and pull-out force for compression staples (ASTM F-564); torque to failure and pull-out force for non-locking cortical screws (ASTM F-543).

Technological Characteristics

Materials: Medical grade stainless steel alloy (ASTM F-139 and F-138). Components: Compression staple and non-locking cortical screws. Sterilization: Pre-packaged sterile. Mechanical fixation principle.

Indications for Use

Indicated for alignment, stabilization, and fusion of fractures, osteotomies, and arthrodesis of small bones, specifically in the foot and ankle.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Z-Guide Staple (K121277)
• Arthrex Low Profile Screw (K103705)
• BioDrive™ Micro Screw System (K092670)

Submission Summary (Full Text)

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# 510(k) Summary (Per 21 CFR 807.92)

### General Company Information:

Nextremity Solutions, Inc. Jorge A. Montoya Director, Product Development 60 Broad Street, Suite 102 Red Bank, NJ 07701 Phone: [phone] Fax: [phone]

AUG 2 8 2013

#### Date Prepared

May 29, 2013

**General Device Information**

Product Name:

Classification:

Restore™ Fixation System

Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030 Product codes: JDR (staple fixation, bone) and HRS (plate fixation, bone)

Smooth or threaded metallic bone fixation fastener and accessories 21 CFR 888.3040 Product code: HWC (screw, fixation, bone)

Class II device

#### Predicate Devices

Z-Medical GmbH &Co. KG

Arthrex Inc.

Biomet Trauma

Z-Guide Staple (Marketed as Z-Medical Staple) [510(k) K121277]

Arthrex Low Profile Screw (Marketed as Arthrex Low Profile Screw) [510(k) K103705]

BioDrive™ Micro Screw System (Marketed as BioDrive™ Micro Nail Plate/Screw) [510(k) K092670]

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#### Description

The Restore™ Fixation System consists of a compression staple and two non-locking cortical screws (one for optional use) with surgical site preparation and insertion instruments. The compression staple and cortical screw are fabricated from medical grade stainless steel alloy (ASTM F-139 and F-138) and are pre-packaged sterile.

#### Intended Use (Indications)

The Restore™ Fixation System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

#### Substantial Equivalence

The Restore™ Fixation System possesses the same indication and technological characteristics (basic design, material, size and fundamental technology) of the predicate devices.

#### Performance Data

Mechanical testing was performed as described in relevant recognized standards, including testing for 4 point bending (static and dynamic) and pull-out force for the compression staple per ASTM F-564 and torque to failure and pull-out force for the non-locking cortical screw per ASTM F-543.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

August 28, 2013

Mr. Jorge A. Montoya Director, Product Development Nextremity Solutions, Incorporated 60 Broad Street, Suite 102 Red Bank, New Jersey 07701

Re: K131061

Trade/Device Name: Restore™ Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, HRS, HWC Dated: May 29, 2013 Received: May 30, 2013

Dear Mr. Montoya:

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

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# Page 2 - Mr. Jorge A. Montoya

device-related adverse events) (21 CFR 803); 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.

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.goy/MedicalDevices/Safety/ReportaProblem/deliault.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/default.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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#### Indications for Use Statement

510(k) Number (if known): K131061

Device Name: Restore™ Fixation System

Indications For Use:

The Restore™ Fixation System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth L. Frank -S

Division of Orthopedic Devices