NeoSpan Compression Staple Impant w/instruments

K161426 · In2bones USA, LLC · JDR · Oct 24, 2016 · Orthopedic

Device Facts

• Record ID: K161426
• Device Name: NeoSpan Compression Staple Impant w/instruments
• Applicant: In2bones USA, LLC
• Product Code: JDR · Orthopedic
• Decision Date: Oct 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

Device Story

NeoSpan™ Compression Staple Implant is a superelastic Nitinol bone staple designed for orthopedic fixation. Device holds bone fragments together to facilitate healing. Used in hand and foot surgery for osteotomy fixation and joint arthrodesis. Operated by surgeons in clinical/OR settings. Implanted into two pre-drilled holes in bone; provides compression across fracture or fusion site. Benefits include stable fixation during bone healing process.

Clinical Evidence

Bench testing only. Testing included pyrogenicity, corrosion, static bending, fatigue bending, and pullout fixation. Results demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Material: Superelastic Nitinol. Form factor: Multi-size compression staple. Principle: Superelasticity provides continuous compression across bone interface. Deployment: Manual insertion into pre-drilled bone holes. Non-software device.

Indications for Use

Indicated for patients requiring fixation of hand and foot bone fragments, osteotomy fixation, and joint arthrodesis.

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

• Vilex eZ-Staple Superelastic Bone Fixation Staple (K112837)
• Stryker EasyClip (K122113)

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a scarf.

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

October 24, 2016

In2BonesUSA, LLC % Ms. Louise Focht President ENMED International, Inc. P.O. Box 249 Del Mar. California 92014

Re: K161426

Trade/Device Name: NeoSpan™ Compression Staple Implant w/instruments 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: September 15, 2016 Received: September 19, 2016

Dear Ms. Focht:

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 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,

## Vincent J. Devlin -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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017 | |
|-------------------------------------------------------------------------|--|-----------------------------------------------------------------------|--|
| Indications for Use | | See PRA Statement below. | |

| 510(k) Number (if known) | K161426 |
|--------------------------|----------------------------------------------------------------|
| Device Name | NeoSpan ^TM Compression Staple Implant w/instruments |

Indications for Use (Describe)

The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <span style="display: inline-block;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="display: inline-block;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) Summary of Safety and Effectiveness K161426

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

- I. Submitter

| Date Prepared: | October 18, 2016 |
|-------------------|-------------------------------------------------------------------------|
| Device Submitter: | In2Bones USA, LLC<br>6060 Poplar Avenue, Suite 380<br>Memphis, TN 38119 |
| Phone: | 901-260-7931 |
| Contact Person: | Louise Focht |

II. Device

| Proprietary Name: | NeoSpan™ Compression Staple Implant w/instruments |
|----------------------|--------------------------------------------------------------------------------|
| Regulation Name: | Single/Multiple Component Metallic Bone Fixation<br>Appliances and Accessories |
| Common Name: | Bone Staple |
| Classification Name: | Staple, Fixation, Bone |
| Regulatory Class: | 21 CFR 880.3030, Class II |
| Product Code: | 87 JDR |

III. Predicate Device

| Predicate Device: | Vilex eZ-Staple Superelastic Bone Fixation Staple K112837<br>Stryker EasyClip K122113 |
|-------------------|---------------------------------------------------------------------------------------|
|-------------------|---------------------------------------------------------------------------------------|

- IV. Device Description
The In2Bones NeoSpan™ Compression Staple Implant w/instruments is a super elastic compression staple made of superelastic Nitinol. The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs.

- V. Intended Use and Indications for Use
The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

Comparison of technological characteristics with the predicate device VI.

The In2Bones USA NeoSpan™ Compression Staple Implant and the legally marketed predicate device have the same intended use and indications for use, same dimensions, geometry and

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materials. The In2Bones device and the predicate are both available in multiple sizes. The staples are fit into two holes drilled into various bones to provide fixation for bone fracture, osteotomy and fusion. The In2Bones USA NeoSpan™ Compression Staple Implant is made from superelastic nitinol.

## VII. Performance Data

Testing including pyrogenicity, corrosion, static bending, fatigue bending and pullout fixation was performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified

## VIII. Conclusions

The In2Bones USA NeoSpan™ Compression Staple Implant when compared to the predicate have the similar intended use and indications for use, technological characteristics, and principals of operation as the predicate device. Thus the In2Bones USA NeoSpan™ Compression Staple Implant design characteristics do not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate device.