Renovis Anterior Cervical Plate System

K152193 · Renovis Surgical Technologies, Inc. · KWQ · Sep 25, 2015 · Orthopedic

Device Facts

• Record ID: K152193
• Device Name: Renovis Anterior Cervical Plate System
• Applicant: Renovis Surgical Technologies, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions: degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis trauma (i.e., fracture or dislocation) spinal stenosis tumor pseudoarthrosis failed previous fusion WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

System comprises titanium alloy plates/screws and nickel-titanium alloy locking clips; used for anterior cervical spine fixation (C2-C7). Device provides temporary stabilization during fusion development. Implanted by surgeons in clinical settings. Plates available in various lengths for single or multi-level procedures. Output is mechanical stabilization of vertebral segments. Benefits include structural support for spinal fusion in patients with degenerative conditions, trauma, or tumors.

Clinical Evidence

Bench testing only. Testing included static axial compression bending, static torsion, dynamic axial compression bending (ASTM F1717), corrosion testing (ASTM F2129), Auger Emission Spectroscopy (AES) for nitinol clips, and screw push-out testing. All results were acceptable.

Technological Characteristics

Materials: Titanium alloy (ASTM F136), Nickel-Titanium alloy (ASTM F2063). Components: Plates, screws, locking clips. Mechanical fixation principle. Sterilization: Moist heat (ISO 17665-1). Standards: ASTM F1717 (spinal constructs), ASTM F2129 (corrosion), ASTM F86 (surface prep), ASTM F983 (marking).

Indications for Use

Indicated for patients (C2-C7) requiring temporary anterior spinal stabilization during fusion development due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, tumor, pseudoarthrosis, or failed previous fusion. Contraindicated for posterior element (pedicle) fixation.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Synthes Anterior CSLP System (K030866)
• Synthes Anterior Cervical Vertebrae Plate System (K945700)
• Trestle Luxe Anterior Cervical Plating System, Alphatec Spine (K102820)

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

Renovis Surgical Technologies, Incorporated % Sharyn Orton, Ph.D. Senior Consultant MEDIcept Incorporated 200 Homer Avenue Ashland, Massachusetts 01721

September 25, 2015

Re: K152193

Trade/Device Name: Renovis Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 30, 2015 Received: August 5, 2015

Dear Dr. Orton:

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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Sharyn Orton, Ph.D.

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" (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 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K152193

Device Name Renovis Anterior Cervical Plate System

Indications for Use (Describe)

The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7).The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:

· degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

- · spondylolisthesis
- · trauma (i.e., fracture or dislocation)
- · spinal stenosis
- · tumor
- · pseudoarthrosis
- · failed previous fusion

WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### Traditional 510(k) Summary as required by 21 CFR 807.92(a)

- A) Submitted by: Renovis Surgical Technologies 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374 Phone: [phone] Fax: [phone]
- Official Contact: Anthony DeBenedictis Vice President of Quality Assurance
- Consultant: Sharyn Orton, Ph.D. MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721
- Prepared: September 23, 2015
- B) Classification Name: Spinal Intervertebral Body Fixation Orthosis

| Common Name: | Anterior Cervical Plate, Anterior Cervical Spinal Fixation System |
|---------------------------------|-------------------------------------------------------------------|
| Proprietary Name: | Renovis Anterior Cervical Plate System |
| Device Class: | Class II |
| Regulation<br>and Product Code: | 21 CFR 888.3060<br>KWQ |
| Classification panel: | Orthopedic |
| C) Predicate: | K030866 Synthes Anterior CSLP System |

- D) Device Description
The Renovis Anterior Cervical Plate System consists of various shapes and sizes of plates and screws, and associated instruments. The plates are available in multiple lengths to accommodate single or multi-level surgeries. The plates and screws are manufactured from titanium alloy and the locking clip is manufactured from nickel-titanium alloy.

> Renovis Anterior Cervical Plate System Traditional 510(k) Premarket Notification

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### E) Intended Use/Indications For Use:

The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:

- degenerative disc disease(DDD) (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis ●
- trauma (i.e., fracture or dislocation) ●
- spinal stenosis
- tumor
- pseudoarthrosis
- failed previous fusion .

WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

### F) Substantial Equivalence Comparison

The Renovis Anterior Cervical Plate System and predicate devices (K030866 Synthes Anterior CSLP System: K945700 Synthes Anterior Cervical Vertebrae Plate System: K102820 Trestle Luxe Anterior Cervical Plating System, Alphatec Spine) have the same intended use/ Indications for Use, are manufactured from the same or similar materials, have a screw retention system; and have similar dimensions.

### H) Performance Testing

Performance testing of the Renovis Anterior Cervical Plate System under ASTM F1717, including static axial compression bending, static torsion and dynamic axial compression bending, was conducted and found to be acceptable. Corrosion testing under ASTM F2129 was conducted and found to be acceptable. Auger Emission Spectroscopy (AES) analysis of the nitinol clip was conducted and found to be acceptable. Screw push-out testing was conducted per protocol and found to be acceptable.

I) Compliance with Standards and Guidance

- ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium . ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- . ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
- ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-. Hardening Stainless Steel Bars and Shapes
- ASTM B211-12e1 Standard Specification for Aluminum and Aluminum-Alloy Rolled or . Cold Finished Bar, Rod, and Wire
- ASTM B221-13 Standard Specification for Aluminum and Aluminum-Alloy Extruded ● Bars, Rods, Wire, Profiles, and Tubes

Renovis Anterior Cervical Plate System Traditional 510(k) Premarket Notification

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- . EN 10088-3:2005 Stainless steels - Part 3: Technical delivery conditions for semifinished products, bars, rods, wire, sections and bright products of corrosion resisting steels for general purposes
- ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic . Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
- ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a . Vertebrectomy Model
- ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of . Orthopaedic Implant Components
- ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of . Orthopedic Implants and Instruments
- ISO 17665-1:2006 Sterilization of health care products Moist heat -- Part 1: . Requirements for the development, validation, and routine control of a sterilization process for medical devices
- ASTM F86-13 Standard Practice for Surface Preparation and Marking of Metallic . Surgical Implants

Guidance for Industry and FDA Staff - Spinal System 510(k)s, May 3, 2004, where applicable to anterior cervical plate systems.

## Conclusion

Given testing and other technological comparisons, the Renovis Anterior Cervical Plate System is substantially equivalent to the predicate devices.