Genesys Spine AIS-C Cervical Stand-Alone System

K181295 · Genesys Spine · OVE · Aug 29, 2018 · Orthopedic

Device Facts

• Record ID: K181295
• Device Name: Genesys Spine AIS-C Cervical Stand-Alone System
• Applicant: Genesys Spine
• Product Code: OVE · Orthopedic
• Decision Date: Aug 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Genesys Spine Cervical Stand-Alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.

Device Story

Intervertebral body fusion device; used for anterior cervical fusion. System comprises PEEK or titanium interbodies with integrated titanium alloy locking mechanism and titanium alloy bone anchors. Anchors deployed through interbody channels into adjacent vertebrae to provide stability. Used by surgeons in clinical settings; requires autogenous bone graft. Provides biomechanical support to disc space; may require supplemental fixation depending on patient stability. Benefits include stabilization of cervical segment to facilitate fusion in DDD patients.

Clinical Evidence

Bench testing only. Performed static and dynamic axial compression, compressive-shear, and torsion per ASTM F2077-11; static subsidence per ASTM F2267-04; expulsion testing; and cadaver testing. Results compared to predicate devices to establish equivalence.

Technological Characteristics

Interbody materials: PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti6Al-4V ELI (ASTM F136). Anchors and locking mechanism: Ti6Al-4V ELI (ASTM F136). Form factor: various footprints, heights, and configurations (parallel, lordotic, convex). Integrated fixation via bone anchors. Non-powered, mechanical device.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and radicular symptoms at one level from C2-T1, following six weeks of failed 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

• LDR Spine Cervical Interbody Fusion System – ROI-C (K113559)
• Genesys Spine AIS-C Anchored Cervical Interbody Fusion System (K180056)
• Genesys Spine Apache® Anchored Cervical Interbody Fusion System (K152099)
• Genesys Spine Apache® IBFD System (K103034)

Submission Summary (Full Text)

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August 29, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Genesys Spine Benjamin Keller Product Development Engineer 1250 Capital of Texas Highway South Building 3 Suite 600 Austin, Texas 78746

Re: K181295

Trade/Device Name: Genesys Spine AIS-C Cervical Stand-Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: July 26, 2018 Received: July 30, 2018

Dear Mr. Keller:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Melissa Hall -S

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 (if known) K181295

#### Device Name

Genesys Spine AIS-C Cervical Stand-Alone System

### Indications for Use (Describe)

The Genesys Spine Cervical Stand-Alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|---------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> |

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Image /page/3/Picture/1 description: The image shows the logo for Genesys Spine. The word "Genesys" is written in a combination of brown and gray letters, with the "Ge" in brown and the rest in gray. To the left of the word "Genesys" is a brown graphic that resembles a stylized spine. Below the word "Genesys" is the word "spine" in brown, with a registered trademark symbol next to it.

## 4. 510(K) SUMMARY

| Submitter's Name: | Genesys Spine |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 1250 Capital of Texas Highway South<br>Building Three, Suite 600<br>Austin, Texas 78746 |
| Contact Name: | Benjamin V. Keller (Primary) William W. Sowers (Secondary) |
| Submitter's Telephone: | 512-381-7093 512-381-7080 |
| Submitter's Fax: | 800-817-4938 800-817-4938 |
| Date Summary was Prepared: | August 23, 2018 |
| Trade or Proprietary Name: | Genesys Spine AIS-C Cervical Stand-Alone System |
| Common or Usual Name: | Intervertebral Body Fusion Device, Cervical |
| Classification Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Regulation Number: | 21 CFR 888.3080 |
| Product Codes: | OVE |
| Classification Panel: | Orthopedic Devices Panel |
| Legally Marketed (unmodified) devices to Which Substantial Equivalence is Claimed: | Primary Predicate:<br>LDR Spine Cervical Interbody Fusion System – ROI-C (K113559)<br>Additional Predicate Devices:<br>Genesys Spine AIS-C Anchored Cervical Interbody Fusion System (K180056)<br>Genesys Spine Apache® Anchored Cervical Interbody Fusion System (K152099)<br>Genesys Spine Apache® IBFD System (K103034) |

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## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Genesys Spine AIS-C Cervical Stand-Alone System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium alloy bone anchors.

The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed.

### INDICATIONS FOR USE

The Genesys Spine Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.

### TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The Genesys Spine AIS-C Cervical Stand-Alone System is comprised of two versions of interbodies, each of which are secured by integrated fixation Anchors. The interbodies are available in a PEEK configuration with tantalum markers or in a titanium alloy version. Both versions use the same integrated titanium alloy locking mechanism. The interbodies are to be available in several footprints, configurations, and heights. The titanium alloy cervical bone Anchors provide integrated fixation for the system and are to be offered in various lengths. The bone Anchors are deployed through the channels in the interbody and embed into the adjacent cervical vertebrae.

The PEEK interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disk space. The titanium alloy interbody devices, anchor locking mechanism, and the bone anchor components are manufactured from medical grade Ti6Al-4V ELI titanium alloy per ASTM F136.

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The subject and predicate devices are based on the following same technological elements:

- Integrated fixation Anchors provide additional biomechanical support to the interbody
- . Devices are offered in similar sizes and shapes (parallel, lordotic, and convex) which provide surgeons options to suit the patient's anatomy
- . Implants materials are identical: PEEK, Titanium 6Al-4V ELI alloy, and Tantalum
- Use of a single inserter instrument to position the interbodies and deploy the Anchors ●

### PERFORMANCE DATA

The predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine Cervical Stand-Alone System be equivalent to (or greater than) previously cleared interbody fusion systems. Prior to performing mechanical testing, all possible configurations of the AIS-C Cervical Stand-Alone System constructs were analyzed in order to determine the worst case to be used for testing.

The Genesys Spine AIS-C Cervical Stand-Alone System was tested in static and dynamic axial compression, compressive-shear, and torsion per ASTM F2077-11, static subsidence per ASTM F2267-04, expulsion testing, and cadaver testing. The system was also tested to determine the force to overcome the locking mechanism under worst-case conditions. These results were compared to the predicate devices to establish substantial equivalence.

## CONCLUSION OF NON-CLINICAL TESTS:

The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine AIS-C Cervical Stand-Alone System is substantially equivalent to the LDR Spine Cervical Interbody Fusion System - ROI-C (K113559), the Genesys Spine AIS-C Anchored Cervical Interbody Fusion System (K180056), the Genesys Spine Apache@ Anchored Cervical Interbody Fusion System (K152099), and the Genesys Spine Apache® IBFD System (K103034).