OCTANE ELEVATE SPINAL IMPLANT SYSTEM

K123607 · Exactech, Inc. · MAX · Apr 25, 2014 · Orthopedic

Device Facts

• Record ID: K123607
• Device Name: OCTANE ELEVATE SPINAL IMPLANT SYSTEM
• Applicant: Exactech, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S 1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondvlolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least six (6) months of nonoperative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.

Device Story

The Octane Elevate Spinal Implant is a lumbar intervertebral body fusion device. It is implanted by a surgeon during spinal fusion procedures to provide stability. The device is used in conjunction with autogenous bone graft and supplemental internal fixation systems (e.g., pedicle screws, rods, or plates) to facilitate fusion. It is intended for patients with degenerative disc disease at one or two contiguous levels from L2 to S1. The implant provides structural support to the intervertebral space, promoting fusion and potentially reducing pain associated with discogenic origin. The device is provided sterile.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance validated via static and dynamic compression, static and dynamic compressive shear, and subsidence yield force testing per ASTM F2077 and ASTM F2267 standards.

Technological Characteristics

Materials: PEEK-Optima and tantalum. Form factor: Intervertebral body fusion cage. Sterilization: Provided sterile. Mechanical testing standards: ASTM F2077, ASTM F2267.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous lumbar levels (L2-S1), including up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months of failed nonoperative treatment. Contraindicated for patients without discogenic back pain or those not meeting skeletal maturity.

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

• Spinal Elements Lucent (K071724)
• Innesis PEEK Cage System (K120464)
• AccuLiF TL-PEEK Cage (K112095 & K123281)

Submission Summary (Full Text)

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# Exactech® Octane® Elevate™ Spinal Implant System Traditional 510(k)

# 510(k) Summary

# APR 2 5 2014

Exactech®, Inc Company: 2320 Northwest 66th Court Gainesville, FL 32653-1630 Date: April 21, 2014 Contact Person: Patrick Hughes Senior Regulatory Affairs Specialist Phone: [phone] Fax: [phone] E-mail: [e-mail] Exactech® Octane® Elevate™ Spinal Implant Proprietary Name: Common Name: Intervertebral body fusion system

### Classification Name:

Intervertebral Fusion Device - Lumbar (21 CFR 888.3080, Class II, Product Code MAX)

### Legally Marketed Devices to Which Substantial Equivalence Is Claimed

Spinal Elements Lucent (#K071724) Innesis PEEK Cage System (#K120464) AccuLiF TL-PEEK Cage (#K112095 & #K123281)

### Device Description

This submission proposes a new lumbar interbody fusion system. The Octane Elevate Spinal Implant is designed to provide stability during intervertebral body fusion in the lumbrosacral spine.

### Indications for Use

The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S 1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondvlolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least six (6) months of nonoperative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.

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# Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

- . Intended Use
Proposed Octane Elevate devices and cited predicates are intended to be used with bone graft and supplemental fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) for intervertebral fusion for treatment of degenerative disc disease at the levels of L2-S1.

#### Materials .

Octane Elevate devices and cited predicate devices are made from the same PEEK-Optima and tantalum materials having demonstrable histories of safe and effective use in medical applications. per internationally recognized consensus standards.

#### . Dimensions

Octane Elevate devices and cited predicate devices have substantially equivalent dimensions and are available in substantially equivalent size ranges.

#### . Sterilization processes

Octane Elevate devices are provided sterile. These devices are sterilized using sterilization processes conforming to recognized industry standards.

#### Performance specifications .

Mechanical testing results summarized in this 510(k) premarket notification demonstrate Octane Elevate devices have substantially equivalent performance characteristics compared to cited predicates based on testing per ASTM F2077 and ASTM F2267:

- Static compression .
- . Dynamic compression
- Static compressive shear .
- Dynamic compression shear .
- . Subsidence vield force

# Substantial Equivalence Conclusion

The Octane Elevate Spinal Implant System is substantially equivalent to cited predicates per intended use, materials, dimensions, sterilization processes, and performance characteristics.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 25, 2014

Exactech®. Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653

Re: K123607

Trade/Device Name: Exactech® Octane® Elevate™ Spinal Implant Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 21. 2014 Received: April 23, 2014

Dear Mr. Hughes:

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 cither 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 is 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. Patrick Hughes

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the requlation 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/Reportal?roblem/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.

# Ronald P. Jean -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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# Exactech® Octane® Elevate™ Spinal Implant System Traditional 510(k)

# Indications for Use Statement

510(k) Number: K123607

Device Name: Exactech® Octane® Elevate™ Spinal Implant

### INDICATIONS FOR USE:

The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S 1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least six (6) months of nonoperative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.

Prescription Use X and/or (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Anton E. Dmitriev. PhD Division of