OS2-V Varisation Staple

K143323 · In2bones Sas · JDR · Feb 26, 2015 · Orthopedic

Device Facts

• Record ID: K143323
• Device Name: OS2-V Varisation Staple
• Applicant: In2bones Sas
• Product Code: JDR · Orthopedic
• Decision Date: Feb 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Metallic bone staple with two self-drilling tips; used for fixation in Akin type osteotomies to correct valgus deformation of first ray. Available in 90° and 26° angles; 8mm and 10mm interaxis. Used in hospital or outpatient surgery centers by surgeons. Implanted into bone for >30 days to provide mechanical fixation during bone healing. Single-use device; supplied sterile via gamma irradiation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Metallic staple; 316LVM stainless steel (ISO 5832-1, ASTM F138). Self-drilling tips; 1mm diameter wire. Available in 8mm/10mm interaxis; 26°/90° angles. Sterile; gamma irradiation. Compliant with ISO 8827.

Indications for Use

Indicated for patients undergoing Akin type osteotomies for correction of valgus deformation of the first ray.

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

• Integra / Newdeal SOLUSTAPLE (K991566)
• Memometal Varisation staple (K070033)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

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

February 26, 2015

IN2Bones SAS % Norman F. Estrin, Ph.D. Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K143323 Trade/Device Name: OS2®-V 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: January 18, 2015 Received: January 29, 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

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Page 2 – Norman F. Estrin, Ph.D.

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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# 004_Indications for Use.pdf

K143323 page 1/1

#### Indications for Use

| 510(k) Number (if known): | Not yet assigned |
|---------------------------|------------------------------------------------------------------------|
| Device Name: | OS2®-V Varisation Staple |
| Indications For Use: | The OS2®-V Varisation Staples are indicated for Akin type osteotomies. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for IN2BONES. The logo is inside of a gray oval shape. The text "IN2BONES" is in white, except for the number "2" which is in orange. There is a white swoosh on the left side of the oval.

## 005_510(k) Summary.pdf

## 510(k) SUMMARY For In2Bones OS2®-V Varisation Staple

| Sponsor identification | In2Bones SAS<br>28 chemin du Petit Bois<br>69130 Ecully – France<br>Phone: [phone]<br>Fax: [phone] |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration number | 3010470577 |
| Date of preparation | 20th February 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 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®-V Varisation Staple |
| Common name | Bone Varisation staple |
| Device classification regulation | 21 CFR 888.3030: Single/multiple component metallic bone<br>fixation appliances and accessories<br>Class II |
| Device Product Code and Panel | JDR: staple, fixation, bone<br>87 orthopedics |

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| Device Description | The OS2®-V Varisation Staple is a metallic staple with two self- drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface.<br>Sizes: The OS2®-V Varisation Staple is available in various angles (90° and 26°) and interaxis (8mm and 10mm).<br>Material: The OS2®-V Varisation Staple is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138. It does not have any coating.<br>Single use: The OS2®-V Varisation Staple is designed for single use only.<br>Sterilization: The OS2®-V Varisation Staple is supplied sterile, using gamma irradiation.<br>Place of use: The OS2®-V Varisation Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Devices | Integra / Newdeal SOLUSTAPLE (K991566)<br>Memometal Varisation staple (K070033) |
| Indications for use: | The OS2®-V Varisation Staples are indicated for Akin type osteotomies |

### COMPARISON OF THE INDICATIONS FOR USE WITH THE PREDICATE DEVICES:

As with the predicate devices, the OS2°-V Varisation Staple is indicated for surgical implantation longer than 30 days in the fixation of bone fractures or for bone reconstruction.

| 510k number | K991566 | Substantial equivalence discussion | |
|---------------------|------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| manufacturer | In2Bones | Integra / Newdeal | |
| Name of device | OS2®-V Varisation Staple | SOLUSTAPLE | OS2®-V Varisation Staple has exactly the same indications for use as the SOLUSTAPLE: “Akin type osteotomy” |
| Indications for use | The OS2®-V Varisation Staples are indicated for Akin type osteotomies. | The SOLUSTAPLE® is indicated for Akin type osteotomy | |

| 510k number | K070033 | Substantial equivalence<br>discussion |
|-----------------------|--------------------------------|--------------------------------------------------|
| manufacturer In2Bones | Memometal Varisation<br>staple | OS2®-V Varisation Staple<br>has exactly the same |

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| Name of<br>device | OS2®-V Varisation<br>Staple | Varisation staple | indications for use as the<br>Memometal Varisation |
|------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------|
| Indications<br>for use | The OS2®-V<br>Varisation Staples are<br>indicated for Akin<br>type osteotomies. | The Memometal<br>Varisation Staple is<br>indicated for Akin type<br>osteotomy | staple: “Akin type<br>osteotomy” |

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| Comparison of<br>Technological<br>characteristics | The technological characteristics of the OS2®-V Varisation<br>Staple are the same as the characteristics of predicate devices in<br>terms of intended use and design. All these implants have the<br>following features:<br>- Insertion into bone: The OS2®-V Varisation Staple and all<br>predicate devices are intended for surgical implantation<br>into bone for longer than 30 days.<br>- Indications for use: The OS2®-V Varisation Staple has<br>similar indications for use when compared to the Integra /<br>Newdeal SOLUSTAPLE (K991566) and Memometal<br>Varisation staple (K070033): all are indicated for Akin<br>type osteotomies.<br>- Design: The OS2®-V Varisation Staple has similar design,<br>when compared to the Integra / Newdeal SOLUSTAPLE<br>(K991566) and Memometal Varisation staple (K070033):<br>all are staples with self-drilling tips, available in straight<br>and angle designs, manufactured from 1mm diameter<br>wire.<br>- Equivalent size range: The OS2®-V Varisation Staple has<br>similar size range, when compared to the Integra /<br>Newdeal SOLUSTAPLE (K991566) and Memometal<br>Varisation staple (K070033): all are staples available in<br>8mm and 10mm interaxis, 10mm leg length, 26° and 90°<br>angulation options.<br>- Material: OS2®-V Varisation Staple has similar raw<br>material, when compared to the Integra / Newdeal<br>SOLUSTAPLE (K991566) and Memometal Varisation<br>staple (K070033): all are manufactured from stainless<br>steel 316L, according to ISO 5832-1 and ASTM F138.<br>The OS2®-V Varisation Staple has similar intended use<br>and mechanical properties when compared to the Integra /<br>Newdeal SOLUSTAPLE (K991566) and Memometal<br>Varisation staple (K070033). Indeed, they are all<br>compliant with standard ISO 8827 “Implants for surgery –<br>staples with parallel legs for orthopaedic use – general<br>requirements”. |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence Summary | The OS2®-V Varisation Staple has similar technological<br>characteristics when compared to the predicate devices.<br>Substantial equivalence discussion is provided here below: |

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| 510k number | K991566 | K070033 | |
|---------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| manufacturer | In2Bones | Integra / Newdeal | Memometal Varisation staple |
| Name of device | OS2®-V Varisation Staple | SOLUSTAPLE | Varisation staple |
| Use | Single use | Single use | Single use |
| Fixation | Bone | Bone | Bone |
| Indications for use | The OS2®-V Varisation Staples are indicated for Akin type osteotomies | The SOLUSTAPLE® is indicated for Akin type osteotomy | The Memometal Varisation Staple is indicated for Akin type osteotomy |
| Design | Staple with self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire. | Staple with self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire. | Staple with self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire. |
| size | available in 8mm and 10mm interaxis, 10mm leg length<br>26° and 90° angulation options | available in 8mm and 10mm interaxis, 10mm leg length<br>26° and 90° angulation options | available in 8mm and 10mm interaxis, 10mm leg length<br>26° and 90° angulation options |
| Raw material | stainless steel 316L, according to ISO 5832-1 and ASTM F138 | stainless steel 316L, according to ISO 5832-1 and ASTM F138 | stainless steel 316L, according to ISO 5832-1 and ASTM F138 |

# Substantial Equivalence Comparison and Discussion

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indications of the OS2®-V Varisation Staples are substantially equivalent to the predicate devices identified in the 510(k) submission. No new materials or processes are used in the development of this implant.

The OS2®-V Varisation Staples are acceptable for the application.