Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

K153250 · Renovis Surgical Technologies · OVE · Mar 16, 2016 · Orthopedic

Device Facts

• Record ID: K153250
• Device Name: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
• Applicant: Renovis Surgical Technologies
• Product Code: OVE · Orthopedic
• Decision Date: Mar 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

Device Story

System comprises Tesera Trabecular Titanium (T3) cages, bone screws, and anterior cover plate assembly; used for cervical intervertebral body fusion. Cages are additively manufactured from Ti-6Al-4V alloy; screws and cover plate also titanium-based (cover plate includes Nitinol). Device implanted by surgeons in clinical settings. When used with cover plate and three screws, system acts as stand-alone fixation; without these, requires supplemental fixation. Cages feature side windows for bone graft visualization. Implants provided sterile via gamma irradiation. System includes reusable instrumentation for implantation. Benefits include vertebral stabilization and reduced expulsion risk.

Clinical Evidence

Bench testing only. Performed static/dynamic compression, shear, and torsion (ASTM F2077-14); subsidence (ASTM F2267-04); expulsion testing; and cover plate corrosion testing (ASTM F2129-08). Finite Element Analysis also conducted. No clinical data presented.

Technological Characteristics

Materials: Ti-6Al-4V (ASTM F136-13) and Nitinol (ASTM F2063-12). Additively manufactured porous titanium cages. Stand-alone fixation via cover plate and screws. Sterilization: Gamma irradiation. No software or electronic components.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Requires autogenous bone graft and at least six weeks of prior non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Nuvasive CoRoent Small Interlock (K102547)
• Depuy/Synthes Zero P (K072981)
• Centinel Spine Stalif-C (K072415)

Reference Devices

• Renovis S128 ALIF (K131122; K140106)
• Renovis S134 ALIF (K142095)

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

March 16, 2016

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

Re: K153250

Trade/Device Name: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE, ODP Dated: February 13, 2016 Received: February 16, 2016

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 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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### Indications for Use

510(k) Number (if known) K153250

#### Device Name

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

#### Indications for Use (Describe)

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the use of three (3) screws and the cover plate assembly.

When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

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

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### Traditional 510(k) Summary as required by 21 CFR 807.92(a) K153250

- A ) Submitted by: Renovis Surgical Technologies Inc. 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

Date prepared: 1-11-2016

B) Device Name: Intervertebral body fusion device with integrated fixation, cervical

- Proprietary Name: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Device Class: Class II
Regulation number: 21 CFR 888.3080

Intervertebral body fusion device Regulation name:

- Product code: OVE - intervertebral fusion device with integrated fixation, cervical ODP - intervertebral fusion device with bone graft, cervical
Classification panel: Orthopedic

- C) Primary Predicate: K102547 Nuvasive CoRoent Small Interlock
D) Device Description:

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes the Tesera Trabecular Titanium (T3) cages, bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System requires no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies, stabilize the vertebral body and reduce the likelihood of expulsion of the implant. The Tesera Trabecular Titanium (T3) cages have

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Traditional 510k Premarket Notification

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## NOWIE

windows in the side for visualization of the bone graft. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. When used without the cover plate and screws, the Tesera SC ACF cages require supplemental fixation.

The Renovis Tesera SC ACF System cages are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V). The bone screws are manufactured from Titanium alloy (Ti-6Al-4V) and the cover plate assembly is manufactured from Titanium alloy (Ti-6Al-4V) and Nitinol alloy. The implants are provided to the end user sterilized through gamma irradiation.

The system also consists of reusable instrumentation used to implant the cages, screws, and cover plate assembly.

The Renovis Tesera SC ACF System implants comply with the following material standards:

- . 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

E) Indications For Use:

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly.

When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

- F) Substantial Equivalence Discussion
Additional predicate devices include the Depuy/Synthes Zero P (K072981) and Centinel Spine Stalif-C (K072415). The Renovis Tesera SC ACF System cage is manufactured from different material than the predicate devices, but has a similar intended use, sizes, basic design, and function. The Renovis Tesera SC ACF System cage is manufactured using the same method (additive manufacturing) as the Renovis FDA cleared S128 ALIF (K131122; K140106) and S134 ALIF (K142095) which are reference devices.

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### G) Performance Testing - Bench

Mechanical testing of the Renovis Tesera SC ACF System included:

- . Subsidence testing without screws per ASTM F2267-04 (reapproved 2011) Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression
- Static Compression, Dynamic Compression, Static Shear Compression, Dynamic Shear . Compression. Static Torsion and Dynamic Torsion Testing per ASTM F2077-14 Test methods for intervertebral body fusion devices
- Expulsion testing with and without screws per ASTM Draft Standard F04.25.02.02 Static ● Expulsion
- . Cover plate assembly corrosion per ASTM F2129-08 Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices
- Finite Element Analysis (cage) ●

Sterilization, shelf life, and packaging studies have been previously conducted.

#### Conclusion

The Renovis Tesera SC ACF System has a similar Indication for Use, sizes, design, and function as the predicate devices. The Renovis Tesera SC ACF System has the same manufacturing process as the reference device.

Differences between the Renovis Tesera SC ACF System and the predicate devices do not raise new issues of safety or effectiveness. The Renovis Tesera SC ACF System is substantially equivalent to the predicate devices.

- H) Other Standards and Guidance
- 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
- . ASTM A564 - Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
- . Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, October 2007
- Guidance for Industry and FDA Staff: Spinal System 510(k)s", May 2004 ●
- . Accepted into previous testing
- ISO 11607-2: 2009 Packaging for terminally sterilized medical devices part 1: o requirements for materials, sterile barrier systems and packaging systems
- Per ASTM F1980-07 Standard guide for accelerated aging of sterile . barrier systems for medical devices

Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Traditional 510k Premarket Notification

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# NOWIS

- ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: o Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013 Sterilization of health care products Radiation Part 2: O Establishing the sterilization dose
- ISTA 2A, 2011, Partial-Simulation Performance Test Procedure: Packaged o Products 150lb (68 kg) or Less
- ASTM D4169:2009, Standard Practice for Performance Testing of Shipping O Containers and Systems
- ISO 17665-1:2006 Sterilization of health care products Moist heat -- Part 1: O Requirements for the development, validation, and routine control of a sterilization process for medical devices.