NEOVIEW Plating System

K160995 · In2bones Sas · HRS · Jun 10, 2016 · Orthopedic

Device Facts

• Record ID: K160995
• Device Name: NEOVIEW Plating System
• Applicant: In2bones Sas
• Product Code: HRS · Orthopedic
• Decision Date: Jun 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NEOVIEW® Plating System is intended for fixation of intra-articular fractures of the distal radius and reconstruction of the distal radius.

Device Story

The NEOVIEW® Plating System is a bone fixation device consisting of PEEK plates and titanium alloy screws. It is used in hospitals or outpatient surgery centers by surgeons to stabilize distal radius fractures. The plates are radiolucent and include tantalum markers for visualization. The system is supplied sterile for single use. Surgeons use the plates and screws to fix bone fragments, facilitating reconstruction and healing of the distal radius. The device provides mechanical stability to the fracture site.

Clinical Evidence

Bench testing only. Mechanical testing included static and dynamic bending tests performed by an independent laboratory. The device met all acceptance criteria. Animal and clinical testing were deemed not applicable.

Technological Characteristics

Plates: PEEK (ASTM F2026) with tantalum markers (ASTM F560). Screws: Titanium alloy Ti-6Al-4V (ISO 5832-3, ASTM F136). Principle: Mechanical bone fixation via locking or non-locking screws. Form factor: 4 plate designs, various screw lengths. Sterilization: Gamma irradiation.

Indications for Use

Indicated for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius in 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

• Piccolo Composite™ Distal Volar Radius Plate (K102597)

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

June 10, 2016

In2bones SAS % Norman Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K160995

Trade/Device Name: NEOVIEW® Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: April 7, 2016 Received: April 11, 2016

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

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K160995

Device Name NEOVIEW® Plating System

Indications for Use (Describe)

The NEOVIEW® Plating System is intended for fixation of intra-articular fractures of the distal radius and reconstruction of the distal radius.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <span style="vertical-align: middle;"></span> <span style="vertical-align: middle;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> <span> <span style="vertical-align: middle;"></span> <span style="vertical-align: middle;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </span> |
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## 510(k) SUMMARY For In2Bones NEOVIEW® Plating System

| Sponsor identification | In2Bones SAS<br>28 chemin du Petit Bois<br>69130 Ecully – France<br>Phone: [phone]<br>Fax: [phone] |
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| Establishment<br>registration number | 3010470577 |
| Date of preparation | March 21st, 2016 |
| 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 in<br>the United States<br>NEOVIEW® Plating<br>System | 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 | NEOVIEW® Plating System |
| Common name | NEOVIEW® Distal Radius Plate |
| Device classification<br>regulation | 21 CFR 888.3030: Single/multiple component metallic bone<br>fixation appliances and accessories<br>Class II |
| Device Product<br>Code and Panel | HRS: plate, fixation, bone<br>87 orthopedics |

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| Device Description | The NEOVIEW® Plating System is composed of the<br>NEOVIEW® plates and the associated NEO screws.<br>The NEOVIEW® plate is design to adequately maintain the<br>bone fragments of distal radius and is made of PEEK, a<br>material recognized for its mechanical and radiolucent<br>properties.<br>The fixation of NEOVIEW® plate to the bone is performed<br>by the associated NEO screws that are available on locking<br>or not locking versions. |
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| | Sizes: The NEOVIEW® plates include 4 different designs.<br>The associated NEO screws are available in one diameter<br>and a large range of lengths packaged individually of in a<br>kit.<br>Material: The NEOVIEW® plates are made of PEEK<br>according to standard ASTM F2026 and include a marker<br>made of tantalum according to ASTM F560. The NEO<br>screws are made of Titanium alloy Ti-6Al-4V according to<br>ISO 5832-3 and ASTM F136. |
| | Single use: The NEOVIEW® Plating System is designed for<br>single use only.<br>Sterilization: The NEOVIEW® Plating System is supplied<br>sterile, using gamma irradiation.<br>Place of use: The NEOVIEW® Plating System is indicated<br>for use in a hospital, or outpatient surgery center where |
| Predicate Devices | sterile field may be created and maintained.<br>Piccolo Composite™ Distal Volar Radius Plate (K102597) |
| Indications for use: | The NEOVIEW® Plating System is intended for fixation of<br>intra-articular and extra-articular fractures of the distal<br>radius and reconstruction of the distal radius. |

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| Comparison of the<br>indications for use<br>with the predicate<br>devices: | The indications for use for the NEOVIEW® Plating System are<br>similar to the predicate device Piccolo Composite™ Distal Volar<br>Radius Plate (K102597) in intended use, design, material,<br>technological characteristics and principles of operation. |
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| Comparison of<br>Technological<br>characteristics and<br>Substantial<br>Equivalence<br>Summary: | The NEOVIEW® Plating System is similar to the predicate device<br>Piccolo Composite™ Distal Volar Radius Plate (K102597) in<br>intended use, design, size ranges, principle of operation and<br>materials. |
| Summary<br>Performance Data | Performance testing of the NEOVIEW® Plating System was<br>assessed through mechanical bench testing performed by an<br>independent test laboratory, animal and clinical testing being<br>considered not applicable.<br>Testing performed included static and dynamic bending tests on<br>NEOVIEW® Plating System. The results of the testing performed<br>by the independent test laboratory indicate that the NEOVIEW®<br>Plating System met the acceptance criteria. |
| CONCLUSION | Based on the comparison of indications for use and<br>technological characteristics and the results of the testing<br>performed, the NEOVIEW® Plating System is substantially<br>equivalent to the predicate device identified in the 510(k)<br>submission. |