OS2-C Compression Staple

K153395 · In2bones Sas · JDR · Feb 18, 2016 · Orthopedic

Device Facts

• Record ID: K153395
• Device Name: OS2-C Compression Staple
• Applicant: In2bones Sas
• Product Code: JDR · Orthopedic
• Decision Date: Feb 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OS2®-C Compression Staples are indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery. The number and size of the OS2®-C Compression Staples must be adapted to the indication.

Device Story

OS2®-C Compression Staple is an osteosynthesis implant designed to provide constant, reproducible bone compression. It is manufactured from PEEK-OPTIMA® polymer (ASTM F2026). The device is supplied sterile via gamma irradiation, pre-assembled on an inserter for single-use application. It is intended for use in hospitals or outpatient surgery centers by surgeons. The staple is available in various interaxis lengths (11mm to 15mm) to accommodate specific anatomical requirements. During surgery, the clinician implants the device to stabilize bone segments, facilitating healing through compression. The device is designed for long-term implantation (>30 days).

Clinical Evidence

Bench testing only. Mechanical performance was assessed via comparison with predicate devices according to ASTM F564-06. Animal and clinical testing were deemed not applicable.

Technological Characteristics

Material: PEEK-OPTIMA® polymer (ASTM F2026). Design: Compression staple with various interaxis (11-15mm) and leg lengths. Energy source: None (mechanical). Sterilization: Gamma irradiation. Single-use. No coating.

Indications for Use

Indicated for fixation of arthrodesis, osteotomies, and fractures in hand or foot surgery for patients requiring bone fixation.

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

• Biotech International / EOS Eleos Memory Staple (K112794)
• Integra / Newdeal UNI-CLIP (K011716)
• Memometal Easyclip (K070031)
• Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

February 18, 2016

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

Re: K153395

Trade/Device Name: OS2® -C Compression 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: November 22, 2015 Received: November 24, 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

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

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 yours,

## Mark N. Melkerson -S

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

Enclosure

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

### Indications for Use

510(k) Number (if known) K153395

Device Name

OS2®-C Compression Staple

Indications for Use (Describe)

The OS2®-C Compression Staples are indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery.

The number and size of the OS2®-C Compression Staples must be adapted to the indication.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span>☐</span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

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

Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is in a gray oval shape with a white line that curves around the left side of the oval. The text "IN2BONES" is in white, with the "2" in orange.

# For In2Bones OS2®-C ComMARY
For In2Bones OS2®-C Compression Staple

| Sponsor identification | In2Bones SAS<br>28 chemin du Petit Bois<br>69130 Ecully – France<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration<br>number | 3010470577 |
| Date of preparation | November 20, 2015 |
| Contact person | Norman F. Estrin. Ph.D.<br>Estrin Consulting Group LLC<br>9109 Copenhaver Drive<br>Potomac, MD 20854<br>Phone: [phone]<br>Email: [e-mail] |
| Authorized Agent in the<br>United States | Norman F. Estrin, Ph.D.<br>Estrin Consulting Group LLC<br>9109 Copenhaver Drive<br>Potomac, MD 20854<br>Phone: [phone]<br>Email: [e-mail] |
| Proprietary Name | OS2®-C Compression Staple |
| Common name | Bone Compression staple |
| Device classification<br>regulation | 21 CFR 888.3030: Single/multiple component metallic bone fixation<br>appliances and accessories<br>Class II |
| Device Product<br>Code and Panel | JDR: staple, fixation, bone<br>87 orthopedics |

{4}------------------------------------------------

| Device Description | The OS2®-C Compression Staple is an osteosynthesis staple, enabling a<br>constant and reproducible compression.<br>The OS2®-C Compression Staple is available in multiple lengths and<br>interaxis. It is delivered sterile, ready to use, pre-assembled on its<br>inserter.<br>The implant is manufactured from PEEK-OPTIMA®, polymer from<br>Invibio®, and is designed for single use only.<br>Sizes:<br>The OS2®-C Compression Staple is available in various interaxis from<br>11mm to 15mm.<br>Material:<br>The OS2®-C Compression Staple is manufactured from PEEK<br>according to standard ASTM F2026.<br>It does not have any coating.<br>Single use:<br>The OS2®-C Compression Staple is designed for single use only.<br>Sterilization:<br>The OS2®-C Compression Staple is supplied sterile, using gamma<br>irradiation.<br>Place of use:<br>The OS2®-C Compression Staple is indicated for use in a hospital, or<br>outpatient surgery center where sterile field may be created and<br>maintained. |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Devices | Biotech International / EOS Eleos Memory Staple (K112794)<br>Integra / Newdeal UNI-CLIP (K011716)<br>Memometal Easyclip (K070031)<br>Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586) - PEEK |
| Indications for use: | The OS2®-C Compression Staples are indicated for fixation of<br>arthrodesis, osteotomies and fractures in hand or foot surgery.<br>The number and size of the OS2®-C Compression Staples must be<br>adapted to the indication. |
| Comparison of the<br>indications for use with<br>the predicate devices: | As with the predicate devices, the OS2®-C Compression Staple is<br>indicated for surgical implantation longer than 30 days in the fixation<br>of bone fractures or for bone reconstruction in hand and foot. |
| Comparison of<br>Technological<br>characteristics | The technological characteristics of the OS2®-C Compression Staple<br>are the same as the characteristics of predicate devices in terms of<br>intended use and design. All these implants have the following features:<br>- Insertion into bone: The OS2®-C Compression Staple and all<br>predicate devices are intended for surgical implantation into<br>bone for longer than 30 days.<br>- Design: The OS2®-C Compression Staple has partially similar<br>design, when compared to the Integra / Newdeal UNI-CLIP |
| | (K011716), Memometal Easyclip (K070031), Biotech<br>International / EOS Eleos Memory Staple (K112794) and<br>Memometal Easyclip (K070031); all are compression staples<br>with various interaxis and leg lengths in the range. Any<br>differences of design from staple to staple do not affect the<br>Safety and Effectiveness of the OS2®-C Compression Staple.<br>Material: The OS2®-C Compression Staple are manufactured<br>from the same raw material when compared to the Smith and<br>Nephew Bioraptor 2.3 PK suture anchor (K071586) and meet<br>appropriate ASTM standard.<br>Equivalent size range: The OS2®-C Compression Staple has<br>similar range size when compared to the Biotech International<br>Eleos Memory Staple (K112794), Integra / Newdeal UNI-CLIP<br>(K011716) and Memometal Easyclip (K070031). |
| Substantial Equivalence<br>Summary | The OS2®-C Compression Staple intended use, design, material,<br>technological characteristics and principles of operation are<br>substantially equivalent to those of predicate devices, if applicable.<br>The OS2®-C Compression Staple has similar mechanical properties<br>when compared to the Biotech International Eleos Memory Staple<br>(K112794). |
| Summary Performance<br>Data | Performance assessment for the OS2®-C Compression Staple was made<br>through mechanical comparison with predicate devices, animal and<br>clinical testing being considered not applicable.<br>Mechanical testing for both OS2®-C Compression Staple and predicate<br>device was performed according to ASTM F564-06.<br>The OS2®-C Compression Staple is substantially equivalent to the<br>predicate devices identified in the 510(k) submission. |
| CONCLUSION | Based on the evaluations performed, the design and indications of<br>the OS2®-C Compression Staple are substantially equivalent to the<br>predicate devices identified in the 510(k) submission. No new<br>materials or processes are used in the development of this implant.<br><br>In addition, the results of the testing performed by the test<br>laboratory indicated that the implants performed as expected for<br>each test.<br><br>The OS2®-C Compression Staples are acceptable for the<br>application. |

{5}------------------------------------------------