I.B.S. osteosynthesis screws

K170594 · In2bones Sas · HWC · May 10, 2017 · Orthopedic

Device Facts

• Record ID: K170594
• Device Name: I.B.S. osteosynthesis screws
• Applicant: In2bones Sas
• Product Code: HWC · Orthopedic
• Decision Date: May 10, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The I.B.S.TM compression and neutralization osteosynthesis screws are intended for: - The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs - Osteosynthesis requiring a mono or bicortical compression The size of the chosen screw should be adapted to the specific indications.

Device Story

I.B.S. osteosynthesis screws are metallic bone fixation fasteners used for arthrodesis, osteotomies, or fracture fixation in upper and lower limbs. These are cannulated, self-tapping, and self-drilling screws available in compression and neutralization designs. The device is surgically implanted into bone by a physician. The screws provide mechanical stability to bone segments, facilitating healing. This submission represents a range extension of existing screw lengths and thread configurations for 6.5mm and 2.5mm diameter screws. The device is intended for long-term implantation (>30 days).

Clinical Evidence

Bench testing only. Dimensional comparison and mechanical behavior analysis performed per ASTM F543 (torque to failure, insertion torque, axial pullout strength, self-tapping performance). Pyrogen testing conducted via LAL test per ANSI/AAMI ST72:2011.

Technological Characteristics

Cannulated, self-tapping, self-drilling metallic bone screws. Material: Titanium alloy Ti6Al4V per ISO 5832-3 and ASTM F136. Diameters: 2.5mm and 6.5mm. Sterilization: Not specified.

Indications for Use

Indicated for fixation of arthrodesis, osteotomies, or fractures of long or short bones of upper and lower limbs; requires mono or bicortical compression. Applicable to patients requiring bone fixation.

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

• SBI, Autofix (K052576)
• Biomet Trauma, BioDrive Cannulated screw system (K082874)
• In2Bones, I.B.S.TM 2.0 Osteosynthesis screw (K160174)
• In2Bones, I.B.S.TM Osteosynthesis screw (K131920)
• Acumed, Acutrak screws (K944330)

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

In2Bones SAS % Dr. Norman Estrin

May 10, 2017

Managing Partner Estrin Consulting Group LLC 3100 N. Leisure World Blvd., Apt. 121 Silver Spring, Maryland 20906

Re: K170594

Trade/Device Name: I.B.S. 110 osteosynthesis screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 18, 2017 Received: May 1, 2017

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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.

# 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)

K170594

Device Name

I.B.S.TM osteosynthesis screws

Indications for Use (Describe)

The I.B.S.TM compression and neutralization osteosynthesis screws are intended for:

- The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs

- Osteosynthesis requiring a mono or bicortical compression

The size of the chosen screw should be adapted to the specific indications.

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

X 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 I.B.S.™ osteosynthesis screws device modification

| 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 | May 7, 2017 |
| Contact person | Norman F. Estrin, Ph.D.<br>Estrin Consulting Group LLC<br>3100 N. Leisure World Blvd.<br>Silver Spring, MD 20906<br>Phone: [phone]<br>Email: [e-mail] |
| Authorized Agent in<br>the United States<br>I.B.S.TM 2.0<br>Osteosynthesis Screw | Norman F. Estrin, Ph.D.<br>Estrin Consulting Group LLC<br>3100 N. Leisure World Blvd.<br>Silver Spring, MD 20906<br>Phone: [phone]<br>Email: [e-mail] |
| Initial 510(k) number | K131920 |
| Proprietary Name | I.B.S.TM osteosynthesis screws |
| Common name | Bone fixation screw |
| Device classification<br>regulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixation<br>screw or fastener<br>Class II |
| Device Product<br>Code and Panel | HWC: screw, fixation, bone<br>87 orthopedics |
| Device Description | The modified I.B.STM osteosynthesis screws are a range extension of the existing screw line cleared in K131920 I.B.STM osteosynthesis screw.<br>The modification made on the I.B.S.TM osteosynthesis screw are:<br>I.B.S.TM Osteosynthesis Compression Screw, diameter 6.5mm:<br>- Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references;<br>- Modification of the distal thread to a long distal thread for screws, with total length comprised between 60mm and 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Neutralization Screw, diameter 6.5mm:<br>- Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Compression and Neutralization screw, diameter 2.5mm:<br>- Range extension of the total screw length, with addition of length 30mm, and creation of dedicated references. |
| Predicate Devices | <b>Compression design:</b> SBI, Autofix (K052576) Biomet Trauma, BioDrive Cannulated screw system (K082874) In2Bones, I.B.S.TM 2.0 Osteosynthesis screw (K160174) In2Bones, I.B.S.TM Osteosynthesis screw (K131920) <b>Neutralization design:</b> Acumed, Acutrak screws (K944330) Biomet Trauma, BioDrive Cannulated screw system (K082874) In2Bones, I.B.S.TM 2.0 Osteosynthesis screw (K160174) In2Bones, I.B.S.TM Osteosynthesis screw (K131920) |
| Indications for use: | The I.B.S.TM compression and neutralization osteosynthesis screws are intended for:<br>- The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs<br>- Osteosynthesis requiring a mono or bicortical compression<br>The size of the chosen screw should be adapted to the specific indications. |
| Comparison of<br>Technological<br>characteristics | The technological characteristics of the modified I.B.S.TM osteosynthesis screws are equivalent to the characteristics of predicate devices in terms of design, size range, raw material. All these implants have the following features:<br>- Insertion into bone: The modified I.B.S.TM osteosynthesis screws and all predicate devices are intended for surgical implantation into bone for longer than 30 days.<br>- Design: Predicate devices have similar design as the modified I.B.S.TM osteosynthesis screws. They all are cannulated, self-tapping and self-drilling screws with either a compression or a neutralization design.<br>- Indications for use: Predicate devices have equivalent indications for use as the modified I.B.S.TM Osteosynthesis screws in terms of fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs. These non-identical indications are equivalent and do not impact the safety and effectiveness of the modified I.B.S.TM Osteosynthesis screws.<br>- Equivalent size range: Predicate devices have comparable size range of as the modified I.B.S.TM Osteosynthesis screws. The slightly difference of the predicates does not impact the safety and effectiveness of the modified I.B.S.TM Osteosynthesis screws.<br>The length discrepancies of the I.B.S.TM osteosynthesis screw predicate (K131920) in comparison to the modified I.B.S.TM Osteosynthesis screws 6.5mm diameter are the reason of this Special 510(k) submission and do not impact the safety and effectiveness of the modified I.B.S.TM Osteosynthesis screws 6.5mm diameter, as it is explained in the "Performance Testing" section.<br>- Material: The modified I.B.S.TM osteosynthesis screws have identical raw material, when compared to the predicate: all are manufactured from Titanium alloy Ti6Al4V, according to ISO 5832-3 and ASTM F136 standards. |
| Substantial<br>Equivalence<br>Summary | As described above, the modified I.B.S.TM osteosynthesis screws<br>have similar technological characteristics when compared to the<br>predicate devices. |
| Summary<br>Performance<br>Data | The dimensional modifications between the unmodified I.B.S.TM<br>osteosynthesis Screws, K131920, and the modified I.B.S.TM<br>osteosynthesis Screws have been evaluated through dimensional<br>comparison with predicate devices and analysis of the impact on<br>mechanical behavior based on standard ASTM F543.<br>This standard describes methods to assess the torque to failure,<br>insertion torque, axial pullout strength, and self-tapping<br>performance of screws. No new bench testing was deemed<br>required to assess the torsional properties, driving torque and<br>axial pullout of the modified I.B.S.TM osteosynthesis screws.<br>Therefore, the subject device was demonstrated to be as safe<br>and effective as the above predicates |
| Pyrogen testing | The method used to make the determination that the device<br>meets pyrogen limit specification is the Limulus Amebocyte<br>Lysate (LAL) test in accordance with ANSI/AAMI<br>ST72:2011: Bacterial endotoxins – Test methods, routine<br>monitoring and alternative to batch testing. |
| CONCLUSION | Based on the evaluations and the results of the dimensional<br>comparison performed, the design and indications of the<br>modified I.B.S.TM osteosynthesis screws are substantially<br>equivalent to the predicate devices identified in the 510(k)<br>submission. No new materials or processes are used in the<br>development of this implant.<br>The modified I.B.S.TM osteosynthesis screws are acceptable<br>for the application. |

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