In2Bones Kirschner wire

K153204 · In2bones Sas · HTY · Feb 1, 2016 · Orthopedic

Device Facts

• Record ID: K153204
• Device Name: In2Bones Kirschner wire
• Applicant: In2bones Sas
• Product Code: HTY · Orthopedic
• Decision Date: Feb 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the In2Bones® Kirschner wire chosen should be adapted to the specific indication.

Device Story

In2Bones® Kirschner wire is a metallic orthopedic fixation device; used for bone fracture fixation, reconstruction, and as guide pins for other implants. Device consists of stainless steel wire available in four point styles (sharp, partially threaded, lanceolate, both ends sharp); diameters 0.8mm to 2.5mm; lengths 70mm to 300mm. Operated by surgeons in hospitals or outpatient surgery centers using standard surgical power tools for insertion. Device provides mechanical stabilization of bone segments; facilitates surgical procedures. Single-use only; supplied sterile (gamma radiation) or non-sterile (requires steam sterilization).

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by design, material, and size comparisons to legally marketed predicate devices and conformance to ISO 5838-1 (2013).

Technological Characteristics

Material: Stainless steel 316LVM (ISO 5832-1, ASTM F138-13). Form factor: Metallic wire, 0.8-2.5mm diameter, 70-300mm length. Point styles: Sharp, partially threaded, lanceolate, double-ended sharp. Sterilization: Gamma radiation (sterile) or steam (non-sterile). No coating. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring bone fracture fixation, bone reconstruction, or guide pins for implant insertion.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• NEWDEAL K WIRE (K022599)
• Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins (K983121)

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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 1, 2016

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

Re: K153204

Trade/Device Name: In2Bones® Kirschner Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: November 1, 2015 Received: November 4, 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 (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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## 005_Indications for Use.pdf

## Indications for Use

| 510(k) Number (if known): | Not yet assigned K153204 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | In2Bones® Kirschner wire |
| Indications For Use: | The In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the In2Bones® Kirschner wire chosen should be adapted to the specific indication. |

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/1 description: The image shows the logo for IN2BONES. The logo is set on a gray oval background. The text "IN2BONES" is in white, with the "2" in orange.

## 510(k) SUMMARY For In2Bones® Kirschner wire

| Sponsor<br>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 | October 28, 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>Cell: 240-994-9999<br>Email: [e-mail] |
| Authorized Agent<br>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>Cell: 240-994-9999<br>Email: [e-mail] |
| Proprietary Name | In2Bones® Kirschner wire |
| Common name | Osteosynthesis wire |
| Device<br>classification<br>regulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixation<br>fastener<br>Class II |
| Device Product<br>Code and Panel | HTY: Pin, Fixation, Smooth<br>JDW: Pin, Fixation, Threaded<br>87 orthopedics |
| Device Description | The In2Bones® Kirschner wire is a metallic wire available in four<br>point styles: sharp, partially threaded, lanceolate, both ends sharp.<br>One part is fixed on standard surgical power tool equipment for<br>insertion. |
| | Sizes: The In2Bones® Kirschner wire is available in various<br>diameters (0.8mm to 2.5mm) and length (70mm to 300mm). |
| | Material: The In2Bones® Kirschner wire is manufactured from<br>stainless steel 316LVM, according to ISO 5832-1 and ASTM<br>F138-13. It does not have any coating. |
| | Single use: The In2Bones® Kirschner wire is designed for single<br>use only. |
| | Sterilization: The In2Bones® Kirschner wire is supplied sterile and<br>non-sterile. The sterile In2Bones® Kirschner wire is sterilized<br>using gamma radiation. The non-sterile In2Bones® Kirschner wire<br>must be steam sterilized before use. |
| | Place of use: The In2Bones® Kirschner wire is indicated for use in<br>a hospital, or outpatient surgery center, where sterile field may be<br>created and maintained. |
| Predicate Devices | NEWDEAL K WIRE (K022599)<br>Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins<br>(K983121) |
| Indications for use: | The In2Bones® Kirschner wires are indicated for fixation of bone<br>fractures, bone reconstruction, and as guide pins for insertion of<br>other implants. The size of the In2Bones® Kirschner wire chosen<br>should be adapted to the specific indication. |
| Comparison of the<br>indications for use<br>with the predicate<br>devices: | The indications for use for the In2Bones® Kirschner wire are<br>similar to the predicate devices Syntec Taichung Non-sterile<br>Kirschner Wires and Steinmann Pins (K983121) and NEWDEAL<br>K WIRE (K983121). |
| Comparison of<br>Technological<br>characteristics with<br>the predicate<br>devices: | The In2Bones® Kirschner wire is similar to the predicate devices<br>in regards to insertion, design, size ranges, and materials:<br>- They all are intended for surgical implantation into bone for<br>longer than 30 days.<br>- The In2Bones® Kirschner wire has identical design as the<br>Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins<br>(K983121) predicate, except for the partially threaded self-drilling<br>tip. The In2Bones® Kirschner wire has the identical design as the<br>NEWDEAL K WIRE (K022599) predicate, except for the<br>lanceolate self-drilling tip<br>- The In2Bones® Kirschner has similar size range when compared<br>to the predicate devices.<br>- The In2Bones® Kirschner wire has similar raw material, when<br>compared to the NEWDEAL K WIRE (K022599) and Syntec-<br>Taichung Non-sterile Kirschner Wires and Steinmann Pins<br>(K983121): all are manufactured from the same type of stainless<br>steel and meet appropriate ASTM standards. |
| Substantial<br>Equivalence<br>Summary: | The In2Bones® Kirschner wire has similar technological<br>characteristics when compared to the predicate devices<br>The indications for use, design and sizes available are similar and<br>any differences do not impact safety and effectiveness. |
| Summary<br>Performance Data | The In2Bones® Kirschner wires are stainless steel wires with<br>diameters and lengths comparable to those featured in the<br>predicate device systems. The design and indications of the<br>In2Bones® Kirschner wires 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>Moreover, the In2Bones® Kirschner wires conform to the<br>international standard ISO 5838-1 (2013). Testing, therefore, is not<br>needed to demonstrate that the subject devices are substantially<br>equivalent to other legally marketed Kirschner wires. |
| CONCLUSION | Based on the evaluations performed, the design and indications of<br>the In2Bones® Kirschner wires 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>The In2Bones® Kirschner wires are acceptable for the applications<br>requested. |

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