OS2(R)-VP Varisation Staple

K153770 · In2bones Sas · JDR · Mar 21, 2016 · Orthopedic

Device Facts

• Record ID: K153770
• Device Name: OS2(R)-VP Varisation Staple
• Applicant: In2bones Sas
• Product Code: JDR · Orthopedic
• Decision Date: Mar 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OS2®-VP Varisation Staples are indicated for Akin type osteotomies.

Device Story

OS2®-VP Varisation Staple is an osteosynthesis bone staple used for fixation during Akin type osteotomies. Device is manufactured from PEEK; provides mechanical stability and radiolucency. Used in hospital or outpatient surgery centers by surgeons; implanted to facilitate bone healing. Device is single-use; supplied sterile via gamma irradiation. Clinical benefit derived from providing stable fixation of bone segments post-osteotomy.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via comparison with predicate devices using protocols based on ASTM F564. No animal or clinical testing performed.

Technological Characteristics

Material: PEEK (ASTM F2026). Form factor: Staple with various angles. Energy source: None (mechanical fixation). Sterilization: Gamma irradiation. Connectivity: None.

Indications for Use

Indicated for patients undergoing Akin type osteotomies for bone fixation in the 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

• In2Bones OS2®-V Varisation Staple (K143323)
• Memometal Easyclip (K070031)
• Newdeal K Wire (K022599)

Reference Devices

• In2Bones DUAFIT® Interphalangeal Implant (K132912)

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

March 21, 2016

In2Bones SAS % Norman Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K153770 Trade/Device Name: OS2®-VP Varisation Staple 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 30, 2015 Received: December 30, 2015

Dear Dr. Estrin:

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 yours,

# Mark N. Melkerson -S

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 Food and Drug Administration

### Indications for Use

510(k) Number (if known) K153770

Device Name OS2®-VP Varisation Staple

Indications for Use (Describe) The OS2®-VP Varisation Staples are indicated for Akin type osteotomies.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY For In2Bones ÒS2®-VP Varisation Staple

| Sponsor identification | In2Bones SAS<br>28 chemin du Petit Bois<br>69130 Ecully - France<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>registration number | 3010470577 |
| Date of preparation | March 9th, 2016 |
| Contact person | Norman F. Estrin, Ph.D.<br>Estrin Consulting Group LLC<br>9109 Copenhaver Drive<br>Potomac, MD 20854<br>Phone: [phone]<br>Cell: 240-994-9999<br>Email: [e-mail] |
| Authorized Agent in<br>the United States | Norman F. Estrin, Ph.D.<br>Estrin Consulting Group LLC<br>9109 Copenhaver Drive<br>Potomac, MD 20854<br>Phone: [phone]<br>Fax: [phone]<br>Cell: 240-994-9999<br>Email: [e-mail] |
| Proprietary Name | OS2®-VP Varisation Staple |
| Common name | Bone staple |
| Device classification<br>regulation | 21 CFR 888.3030: Single/multiple component metallic bone<br>fixation appliances and accessories<br>Class II |
| Device Product<br>Code and Panel | JDR: staple, fixation, bone<br>87 orthopedics |

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## Device Description

| The OS2®-VP Varisation Staple is an osteosynthesis staple<br>manufactured from PEEK, a material recognized for its<br>mechanical and radiolucent properties.<br>Sizes: The OS2®-VP Varisation Staple is available in various<br>angles.<br>Material: The OS2®-VP Varisation Staple is manufactured<br>from PEEK according to standard ASTM F2026.<br>Single use: The OS2®-VP Varisation Staple is designed for<br>single use only.<br>Sterilization: The OS2®-VP Varisation Staple is supplied<br>sterile, using gamma irradiation.<br>Place of use: The OS2®-VP Varisation Staple is indicated for<br>use in a hospital, or outpatient surgery center where sterile<br>field may be created and maintained. | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Devices | Primary predicate device:<br>In2Bones OS2®-V Varisation Staple (K143323) |
| | Additional predicate device:<br>Memometal Easyclip (K070031)<br>Newdeal K Wire (K022599) |
| | Reference predicate devices:<br>In2Bones DUAFIT® Interphalangeal Implant (K132912) |
| Indications for use: | The OS2®-VP Varisation Staples are indicated for Akin type<br>osteotomies. |
| Comparison of the<br>indications for use<br>with the predicate<br>devices: | OS2®-VP Varisation Staple has indications for use identical<br>to those of OS2®-V Varisation Staple (K143323) primary<br>predicate device. As with the other predicate devices, the<br>OS2®-VP Varisation Staple is indicated for surgical<br>implantation longer than 30 days and for the fixation of bone<br>in foot. |
| Comparison of<br>Technological<br>characteristics and<br>Substantial<br>Equivalence Summary | The OS2®-VP Varisation Staple is similar to the primary<br>predicate device OS2®-V Varisation Staple (K143323) in<br>intended use, design, sizes and principles of operation, and is<br>similar to the reference predicate device In2Bones DUAFIT®<br>Interphalangeal Implant (K132912) in material. |

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| Summary<br>Performance Data | Performance testing has been evaluated for OS2®-VP Varisation<br>Staple through mechanical comparison with predicate devices,<br>animal and clinical testing being considered not applicable.<br>Mechanical testing was performed according to dedicated protocols<br>based on standard ASTM F564. The results of the testing performed<br>by the test laboratories indicate that the OS2®-VP Varisation Staple<br>performed as expected for each test. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONCLUSION | Based on the comparison of indications for use and<br>technological characteristics and the results of the testing<br>performed, the OS2®-VP Varisation Staples are substantially<br>equivalent to the predicate devices identified in the 510(k)<br>submission. |