ORTHOHELIX STAPLE SYSTEM

K130832 · Orthohelix Surgical Designs, Inc. · JDR · Aug 15, 2013 · Orthopedic

Device Facts

• Record ID: K130832
• Device Name: ORTHOHELIX STAPLE SYSTEM
• Applicant: Orthohelix Surgical Designs, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Aug 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

Device Story

OrthoHelix™ Staple System consists of shape memory nickel titanium alloy bone staples; used for fixation of fractures, fusions, and osteotomies in hand and foot. Staples provided in various lengths, widths, and thicknesses. Device implanted by surgeons to provide bone fixation. Performance validated via mechanical bending and pullout testing.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes engineering calculations, finite element analysis, mechanical bending and pullout tests (ASTM F564), and corrosion testing (ASTM F2129).

Technological Characteristics

Material: Nickel titanium alloy conforming to ASTM F2063. Principle: Shape memory alloy for bone fixation. Form factor: Staples of varying lengths, widths, and thicknesses. Sterilization: Not specified.

Indications for Use

Indicated for fixation of fractures, fusions, and osteotomies in the hand and foot.

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

• Stryker (Memometal Technologies) EasyClip Staple (K070031)
• BioMedical Enterprises Inc. Speed Staple (K993714)

Submission Summary (Full Text)

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## 510(k) SUMMARY

## Submitter Information

| Submitter's Name: | OrthoHelix Surgical Designs, Inc. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1065 Medina Rd, Suite 500<br>Medina, Ohio 44256 |
| Telephone Number: | 330-869-9562 |
| Fax Number: | 330-247-1598 |
| Prepared By: | Liz Altenau, Brian Hockett, and Caitlin Miller |
| Contact Person: | Brian Hockett or Derek Lewis |
| Date Prepared: | 3/13/2013 |
| Device Information | |
| Trade Name: | OrthoHelix™ Staple System |
| Common Name: | Bone Staple |
| Classification Name: | Staple, Fixation, Bone |
| Device Classification: | Single/multiple component metallic bone fixation appliances and accessories<br>Class II per 21 CFR 888.3030<br>Panel: Orthopedic, Product Code: JDR |
| Material Composition: | Nickel Titanium Alloy |
| Device Description: | The OrthoHelix™ Staple System consists of various sizes of staples used for<br>fixation in the hand and foot. The staples are offered in different lengths,<br>widths, and thicknesses. All implantable devices within this system are<br>manufactured from shape memory nickel titanium alloy. |
| Intended Use: | The OrthoHelix™ Staple System is indicated for fixation in the hand and foot<br>including fractures, fusions, and osteotomies. |
| Substantial Equivalence: | The new OrthoHelix™ staples are substantially equivalent to the Stryker<br>(Memometal Technologies) EasyClip Staple (K070031) and the BioMedical<br>Enterprises Inc. Speed Staple (K993714). The OrthoHelix™ Staple System<br>conforms to ASTM F2063 Standard Specification for Wrought Nickel-Titanium<br>Shape Memory Alloys for Medical Devices and Surgical implants. Engineering<br>calculations, finite element analysis, mechanical bending and pullout tests per<br>ASTM F564, and corrosion testing per ASTMF2129 were performed to<br>demonstrate substantial equivalence of the subject to the predicate devices.<br>No new issues of safety and effectiveness have been raised. |

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

August 15. 2013

OrthoHelix Surgical Designs, Incorporated % Mr. Brian Hockett Portfolio Manager 1065 Medina Road, Suite 500 Medina, Ohio 44256

Re: K130832

Trade/Device Name: OrthoHelix™ Staple 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 Dated: July 2, 2013 Received: July 3, 2013

Dear Mr. Hockett:

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. Brian Hockett

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/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 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 - Erin - Erin - Erin - The Bring - Ering - Ering - Ering - Ering - Ering - The Bring - The Bring - The Bring - The Bring - The Bring - The Bring - The Bring - The Bring

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

510(k) Number (if known): K130832

Device Name: OrthoHelix™ Staple System

Indications for Use:

The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

Prescription Use _ X

AND/OR

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

(Part 21 CFR 801 Subpart D)

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(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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Casey L. Hanley, Ph.D.
Division of Orthopedic Devices