STABILIZATION SCREW

K131920 · In2bones Sas · HWC · May 1, 2014 · Orthopedic

Device Facts

• Record ID: K131920
• Device Name: STABILIZATION SCREW
• Applicant: In2bones Sas
• Product Code: HWC · Orthopedic
• Decision Date: May 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

I.B.S.™ osteosynthesis screws are cannulated, self-drilling, and self-tapping metallic bone fixation fasteners. Available in compression (non-threaded shaft) and neutralization (fully threaded) designs. Used by surgeons in hospitals or outpatient surgery centers to stabilize bone fragments during orthopedic procedures. Cannulation allows for insertion over a guide wire. Compression design facilitates bone fragment approximation; neutralization design provides stabilization without strong compression. Supplied sterile via gamma irradiation for single use. Device selection based on patient-specific fracture or osteotomy requirements.

Clinical Evidence

No clinical data. Substantial equivalence is supported by engineering and dimensional comparisons to predicate devices.

Technological Characteristics

Cannulated bone fixation screws; diameters 2.5mm–8.0mm; lengths 20mm–160mm. Material: Titanium alloy Ti6Al4V (ISO 5832-3, ASTM F136). Designs: Compression (non-threaded shaft) and Neutralization (fully threaded). Self-drilling and self-tapping. Sterilization: Gamma irradiation. Single-use.

Indications for Use

Indicated for fixation of arthrodeses, osteotomies, or fractures of long or short bones in upper and lower limbs, and for osteosyntheses requiring mono or bicortical compression.

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 Stabilization screw (K050346)
• SBI Autofix (K052576)
• Synthes 7.0/7.3 cannulated screw (K962011)
• Newdeal QWIX positioning screw (K071639)
• Acumed Acutrak screws (K944330)

Submission Summary (Full Text)

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## 510(k) SUMMARY In2Bones I.B.S.™ osteosynthesis screws

| Sponsor identification: | Eric Fourcault<br>Chief Executive Officer<br>In2Bones™ SAS<br>28 chemin du Petit Bois<br>69130 ECULLY, France<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>registration number: | New Company. Will register following FDA clearance. |
| Date of preparation: | April 29, 2014 |
| Contact person | 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>Email: [e-mail] |
| Authorized U.S. 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>Fax: [phone]<br>Email: [e-mail] |
| Proprietary Name | I.B.S.™ 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, Class II |
| Device Product<br>Code and Panel | HWC: 87 orthopedics |

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| Device Description | Design and features: |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | The I.B.S.TM osteosynthesis screws are cannulated screws,<br>available in a compression and a neutralization design. |
| | The cannulation of the screws provides a helpful feature during |
| | surgery, as a wire is used to guide insertion of the screw. The |
| | compression design has a non-threaded shaft, allowing optimal |
| | compression between the two bone fragments, which may |
| | enhance bone osteosynthesis. |
| | |
| | The neutralization design is fully threaded and may be preferred<br>when stabilization of the bone fragments without strong |
| | compression is required, as for example in some fractures in |
| | multiple fragments, or osteoporotic bone. Both designs are self- |
| | drilling and self-tapping screws, which enables introduction of |
| | the screw without any preparation of the hole (using a drill and |
| | /or a tap) in most cases. |
| | Sizes: |
| | The I.B.S.TM osteosynthesis screws are available in 2.5mm, |
| | 3.0mm, 3.5mm, 4.5mm, 6.0mm, 6.5mm, and 8.0mm diameters, |
| | in length ranging from 20mm to 160mm. |
| | Material: |
| | The I.B.S.TM osteosynthesis screws are manufactured from |
| | titanium alloy Ti6A14Vas per ISO 5832-3 and ASTM F136. |
| | They do not have any coatings.<br>Single use: |
| | The I.B.S.TM osteosynthesis screws are designed for single use |
| | only. |
| | Sterilization: |
| | The I.B.S.TM osteosynthesis screws are supplied sterile, using |
| | gamma irradiation. |
| | Place of use: |
| | The I.B.S.TM osteosynthesis screws are indicated for use in a |
| | hospital, or outpatient surgery center where sterile fields may be |
| | created and maintained. They are prescription devices. |
| Predicate<br>Devices: | Compression design:<br>Newdeal Stabilization screw (K050346) |
| | SBI Autofix (K052576) |
| | Synthes 7.0/7.3 cannulated screw (K962011) |
| | Neutralization design:<br>Newdeal QWIX positioning screw (K071639) |
| | Acumed Acutrak screws (K944330) |
| | Synthes 7.0/7.3 cannulated screw (K962011) |
| Indications for use: | The I.B.S.™ osteosynthesis screws are intended for: |
| | - The fixation of arthrodeses, osteotomies or fractures of long or short<br>bones of the upper and lower limbs |
| | - Osteosyntheses requiring a mono or bicortical compression |
| | The size of the chosen screw should be adapted to the specific<br>indication. |

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## Comparison of the indications for use with the predicate devices:

As with the predicate devices, the I.B.S™ osteosynthesis screws are indicated for surgical
implantation longer than 30 days in the fixation of bone fractures or for bone reco

| Comparison of<br>Technological<br>characteristics | The technological characteristics of the I.B.S.™ osteosynthesis screws<br>are the same as the characteristics of predicates devices in terms of<br>indications for use and design. All the screws have the following<br>features:<br>- Cannulated - the I.B.S.™ osteosynthesis screws and all the<br>predicate devices are cannulated.<br>- Made from Titanium alloys, with no new materials being<br>introduced in the product - the IBS.™ osteosynthesis screws<br>and all predicate devices are manufactured in Titanium alloy<br>TA6V, except the SBI® AutoFix, which is manufactured in<br>Stainless Steel 316L.<br>- Compression design: non-threaded part allowing compression<br>between two bone fragments - The I.B.S.™ Compression screw<br>and all predicate devices have a non-threaded part allowing<br>compression between two bone fragments<br>- Neutralization design: fully threaded - The I.B.S.™<br>Neutralization screw and all predicate devices are fully<br>threaded<br>- Equivalent size range: The diameters and lengths covered by<br>the predicate devices enable to cover all diameters and lengths<br>of the I.B.S.™ osteosynthesis range. |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions | The I.B.S.™ osteosynthesis screw has a similar intended use, materials,<br>dimensions, and designs when compared to the predicate devices. An<br>engineering / dimensional comparison to the predicates was performed to<br>demonstrate substantial equivalence. Based on these similarities, the<br>I.B.S.™ osteosynthesis screws are substantially equivalent to the predicates<br>identified in the 510(k) Summary. |

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Pablic Health Service

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

May 1, 2014

In2Bone SAS % Norman F. Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac. Maryland 20854

Re: K131920

Trade/Device Name: In2Bone I.B.STM Osteosynthesis Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 18. 2014 Received: March 19, 2014

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 docs 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 Part 801); medical device reporting (reporting of medical

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Page 2 - Dr. Norman F. Estrin

device-related 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" (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,

# Lori A. Wiggins

for

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

Enclosure

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### Indications for Use

510(k) Number: K131920 Device Name: I.B.S.™ osteosynthesis screw

Indications For Use:

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

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

- Osteosyntheses requiring a mono or bicortical compression

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

Prescription Use _ _ x _ x (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Limin Sun -S 2014.04.30 18:16:00 -04'00'

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131920