ORTHOHELIX STAPLE SYSTEM

K142148 · Orthohelix Surgical Designs, Inc. · JDR · Aug 21, 2014 · Orthopedic

Device Facts

• Record ID: K142148
• Device Name: ORTHOHELIX STAPLE SYSTEM
• Applicant: Orthohelix Surgical Designs, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Aug 21, 2014
• Decision: SESE
• Submission Type: Special
• 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 metallic bone staples used for fixation in hand and foot surgery; specifically fractures, fusions, and osteotomies. Staples are manufactured from shape memory nickel-titanium alloy. Device is implanted by surgeons in clinical settings. System provides mechanical stabilization of bone segments to facilitate healing. Modification adds new staple sizes to existing product line. Performance verified via engineering calculations, finite element analysis, mechanical bending, and pullout testing.

Clinical Evidence

Bench testing only. Evidence includes engineering calculations, finite element analysis, mechanical bending and pullout tests per ASTM F564, and corrosion testing per ASTM F2129.

Technological Characteristics

Material: Wrought nickel-titanium shape memory alloy (ASTM F2063). Principle: Shape memory fixation. Form factor: Various lengths, widths, and thicknesses of bone staples. Sterilization: Not specified. Connectivity: None (implantable hardware).

Indications for Use

Indicated for bone fixation in the hand and foot, including fractures, fusions, and osteotomies. No specific age or gender restrictions provided.

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

• OrthoHelix Staple System (K130832)
• Stryker (Memometal Technologies) EasyClip Staple (K070031)
• BioMedical Enterprises Inc. Speed Staple (K993714)

Submission Summary (Full Text)

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

August 21, 2014

OrthoHelix Surgical Designs, Inc. Mr. Brian Hockett Director of Engineering - Lower Extremity 1065 Medina Road, Suite 500 Medina, Ohio 44256

Re: K142148 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 16, 2014 Received: August 7, 2014

Dear Mr. Brian 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Brian Hockett

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 vours.

## 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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## Indications for Use

510(k) Number (if known): K142148

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

(Part 21 CFR 801 Subpart D)

Over-The-Counter-Use

(21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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 |
| Contact Person: | Brian Hockett or Liz Altenau |
| Date Prepared: | 7/16/14 |
| 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 Class II per 21 CFR 888.3030 Panel: Orthopedic, Product Code: JDR

Material Composition: Nickel Titanium Alloy

- Device Description: The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.
The OrthoHelix™ Staple System is indicated for fixation in the hand and foot Intended Use: including fractures, fusions, and osteotomies.

Substantial Equivalence: The new OrthoHelix staples are substantially equivalent to the existing Orthohelix Staple System (K130832), the Stryker (Memometal Technologies) EasyClip Staple (K070031), and the BioMedical Enterprises Inc. Speed Staple (K993714). This submission is a modification to the OrthoHelix Staple System to add new staple sizes. The OrthoHelix Staple System conforms to ASTM F2063 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. Engineering calculations, finite element analysis, mechanical bending and pullout tests per ASTM F564, and corrosion testing per ASTMF2129 were performed to demonstrate substantial equivalence of the subject to the predicate devices. No new issues of safety and effectiveness have been raised.