GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM

K130317 · Genesys Spine · ODP · Dec 11, 2013 · Orthopedic

Device Facts

• Record ID: K130317
• Device Name: GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
• Applicant: Genesys Spine
• Product Code: ODP · Orthopedic
• Decision Date: Dec 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Genesys Spine Apache™ IBFD Star Cervical System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

The Genesys Spine Apache™ IBFD Star Cervical System is an intervertebral body fusion device designed for cervical spine surgery. It is implanted via an anterior approach to facilitate fusion in patients with degenerative disc disease. The device is constructed from PEEK (polyether ether ketone) and includes tantalum markers to assist surgeons with radiographic visualization and proper placement during the procedure. It is intended for use by surgeons in a clinical/hospital setting in conjunction with supplemental fixation and autograft. The device provides mechanical support to the intervertebral space, aiming to alleviate discogenic pain and stabilize the affected spinal level. It is a mechanical implant and does not involve software or automated analysis.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance validated via static and dynamic axial compression and torsion (ASTM F2077-11), static subsidence (ASTM F2267-04), and expulsion testing (ASTM draft standard F-04.25.02.02).

Technological Characteristics

Implant material: PEEK Optima LTI (ASTM F2026). Radiopaque markers: Tantalum (ASTM F560). Form factor: Intervertebral cage configurations for anterior cervical approach. Mechanical testing standards: ASTM F2077-11, ASTM F2267-04, ASTM F-04.25.02.02.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-C3 to C7-T1) with radicular symptoms. Requires at least 6 weeks of prior non-operative treatment. Used with supplemental fixation and autograft.

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

• Genesys Spine Apache™ Cervical Interbody System (K103034)
• BAK/Cervical Interbody Fusion System (P980048)
• Eminent Spine Copperhead IBFD (K090064)

Submission Summary (Full Text)

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DEC 1 1 2013

## 5.510(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 |
| Submitter's Telephone: | 512-381-7080 |
| Submitter's Fax: | 800-817-4938 |
| Contact Name: | William W. Sowers |
| Date Summary was<br>Prepared: | 4-Feb-13 |
| Trade or Proprietary Name: | Genesys Spine Apache™ IBFD Star Cervical System |
| Common or Usual Name: | Intervertebral Body Fusion Device, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Codes: | ODP |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Legally Marketed<br>(unmodified) device: | Genesys Spine Apache™ Cervical Interbody System<br>(K103034)<br>BAK/Cervical Interbody Fusion System (P980048)<br>Eminent Spine Copperhead IBFD (K090064) |

Description of the Device Subject to Premarket Notification:

The Genesys Spine Apache™ IBFD Star Cervical System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine cervical interbody fusion device, which may be implanted as a single device via an anterior approach.

## INDICATIONS FOR USE

The Genesys Spine Apache™ IBFD Star Cervical System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

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### TECHNICAL CHARACTERISTICS

The Genesys Spine Apache™ IBFD Star Cervical System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.

The Genesys Spine Interbody Fusion System implant components are made of polyether ether ketone (Invibio PEEK Optima LTI) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line.

Results of non-clinical testing relative to static and dynamic testing per ASTM F2077-03, subsidence testing per ASTM F2267-04, and expulsion testing per ASTM draft standard F-04.25.02.02 were used to determine substantial equivilence.

## PERFORMANCE DATA

The Genesys Spine Apache™ IBFD Star Cervical System was tested in static and dynamic axial compression and torsion per ASTM F2077-11, static subsidence per ASTM F2267-04, and expulsion testing per ASTM draft standard F-04.25.02.02.

### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache™ IBFD Star Cervical System is substantially equivalent to the Genesys Spine Apache™ Cervical Interbody System, the Centerpulse BAK/Cervical Interbody Fusion System, and the Eminent Spine Copperhead IBFD

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Image /page/2/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 a stylized eagle emblem, with its wings forming a distinctive, flowing design.

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

December 11, 2013

Genesys Spine Mr. William W. Sowers Vice President of Quality and Regulatory 1250 Capital of Texas Highway South, Building Three, Suite 600 Austin, Texas 78746

Re: K130317

Trade/Device Name: Genesys Spine Apache™ IBFD Star Cervical System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 25, 2013 Received: November 1. 2013

#### Dear Mr. Sowers:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. William W. Sowers

forth in 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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Ronaldingean -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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## 4. INDICATIONS FOR USE STATEMENT

Device Name: Genesys Spine Apache™ IBFD Star Cervical System

The Genesys Spine Apache™ Interbody Fusion Device Star Cervical System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

> Prescription Use ਮ (Part 21 CFR 801 Subpart D)

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

Genesys Spine Apache™ IBFD Star Cervical System