STAPIX SUPERELASTIC IMPLANT BONE STAPLES

K133523 · Instratek, Inc. · JDR · Feb 6, 2014 · Orthopedic

Device Facts

• Record ID: K133523
• Device Name: STAPIX SUPERELASTIC IMPLANT BONE STAPLES
• Applicant: Instratek, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Feb 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet.

Device Story

STAPIX™ Superelastic Implant Bone Staples are orthopedic fixation devices used by surgeons for bone fractures, osteotomies, and arthrodesis in hands and feet. Staples are manufactured from superelastic nickel-titanium (Nitinol) alloy, designed to maintain superelastic properties at room and body temperatures without requiring cold storage or heating. Available in 16 configurations with sizes ranging from 9mm to 24mm. The device provides mechanical fixation to stabilize bone segments during healing. Surgeons implant the staples to facilitate bone fusion or realignment, potentially improving patient outcomes in reconstructive hand and foot surgery.

Clinical Evidence

No clinical data. Performance testing consisted of bench testing including bending fatigue, static bending, and corrosion analysis.

Technological Characteristics

Superelastic nickel-titanium (Nitinol) alloy; finished A(f) temperature of 10°C +/- 7°; 16 configurations; sizes 9mm to 24mm; mechanical fixation; non-powered.

Indications for Use

Indicated for patients requiring osteotomy or arthrodesis of bones and joints in the hands and feet.

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

• Memometal Easyclip (K070031)
• Memory Metal Staples, Easyclip (K122113)
• InteliFUSE (K051408)

Submission Summary (Full Text)

{0}------------------------------------------------

:

## 510(K) SUMMARY K133523

| Submission Correspondent<br>and Owner: | Instratek, Inc.<br>15200 Middlebrook Dr., Suite G<br>Houston, TX 77058<br>USA |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Mr. Jeff Seavey<br>President |
| Date summary prepared: | February 4, 2014 |
| Device trade name: | STAPIX™ Superelastic Implant Bone Staples |
| Device common name: | Bone Staple |
| Device classification name: | Staple, Fixation, Bone<br>JDR at 21 CFR Part 880.3030 |
| Legally marketed device to<br>which the device is<br>substantially equivalent: | Memometal Easyclip Cleared March 19, 2007 under K070031<br>Memory Metal Staples, Easyclip Cleared March 12, 2013 under<br>K122113<br>InteliFUSE, cleared June 29, 2005 under K051408 |
| Description of the device: | The Instratek STAPIX™ Superelastic Implant Bone Staples kits are<br>comprised of superelastic bone staples in 16 configurations. The<br>Nitinol staples have a finished A(f) temperature of 10°C +/7° to<br>ensure that the material is superelastic at room and body<br>temperatures. The Instratek STAPIX™ Superelastic Implant is<br>indicated for use in the treatment of bone fractures, osteotomies,<br>and arthrodesis for the reconstructive surgeon. The device is<br>intended for hand and foot surgery. STAPIX™ bone staples are<br>made from superelastic nickel titanium that does not require cold<br>storage or heating. Implant sizes range from 9mm to 24mm. |
| Intended use of the device: | The Instratek STAPIX™ Superelastic Implant is indicated for use in<br>osteotomy and arthrodesis of bones and joints of the hands and feet. |
| Technological<br>characteristics: | The proposed device has the same technological characteristics as<br>the predicate devices. |
| Testing: | Performance testing consisted of bending fatigue, static bending,<br>and corrosion. |
| Conclusions: | The results of the comparison of design, materials, intended use and<br>technological characteristics demonstrate that the device is as safe<br>and effective as the legally marketed predicate devices. |

.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or a bird in flight, with three curved lines representing its wings.

Public Health Service

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

February 6, 2014

Instratek, Incorporated Mr. Jeff Seavey President 15200 Middlebrook, Suite G Houston, Texas 77058

Re: K133523

Trade/Device Name: STAPIX™ Superelastic Implant Bone Staples 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: December 12, 2013 Received: December 13, 2013

Dear Mr. Seavey:

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

{2}------------------------------------------------

## Page 2 - Mr. Jeff Seavey

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" (21 CFR 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/Resourcesfor You/Industry/default,htm.

Sincerely yours.

Vincen制动Devlin -S

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

{3}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number:

K133523

Device Name:

STAPIX™ Superelastic Implant Bone Staples

Indications for Use:

The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet .

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices