OPTICAGE INTERBODY FUSION DEVICE

K113527 · Interventional Spine, Inc. · MAX · Jan 20, 2012 · Orthopedic

Device Facts

• Record ID: K113527
• Device Name: OPTICAGE INTERBODY FUSION DEVICE
• Applicant: Interventional Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Onticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

Device Story

Lumbar intervertebral body fusion device; titanium alloy construction. Consists of upper/lower plates and two wedges; height adjustable via rotational thread (screw) mechanism. Implanted via posterior or transforaminal approach by surgeons. Used as spacer to maintain disc height and provide structural support; requires autogenous bone graft for fusion. Must be used with supplemental internal spinal fixation (e.g., pedicle screws, facet fixation). Benefits patients by stabilizing spinal segments and promoting bony ingrowth through fenestrated design.

Clinical Evidence

Bench testing only. Testing performed per ASTM F2077 (static/dynamic compression, compression shear, torsional loading) and ASTM F2267 (subsidence). Evaluation included expulsion testing and wear debris/particulate analysis. No clinical data provided.

Technological Characteristics

Implant-grade titanium alloy; rectangular box geometry with toothed surfaces and fenestrations for bony ingrowth. Expandable via rotational thread (screw) mechanism. Dimensions: 21-29mm length, 9-14mm height. Non-sterile, single-use. Requires supplemental internal spinal fixation. Testing per ASTM F2077 and ASTM F2267.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade I spondylolisthesis or retrolisthesis. Requires six months of prior conservative treatment. Contraindicated for patients with previous fusion at the involved levels.

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

• L-Varlock Lumbar Cage (K080537)
• Caliber Spacer (K102293)

Submission Summary (Full Text)

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JAN 2 0 2012

## Section 6

# 510(k) Summary

| APPLICANT: | Interventional Spine, Inc. |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | November 27, 2011 |
| CONTACT PERSON: | Jane Metcalf<br>13700 Alton Parkway, STE 160<br>Irvine, CA 92618<br>Phone: [phone]<br>Fax: [phone] |
| TRADE NAME: | Opticage™ Interbody Fusion Device |
| COMMON NAME: | Spinal Implant |
| CLASSIFICATION<br>NAME: | Intervertebral Body Fusion Device |
| DEVICE<br>CLASSIFICATION: | Class II |
| REGULATION<br>NUMBER | 888.3080 (product code: MAX) |
| PREDICATE DEVICES: | L-Varlock Lumbar Cage (K080537)<br>Caliber Spacer (K102293) |

### Substantially Equivalent To

The Opticage Interbody Fusion Device is substantially equivalent in intended use, principal of operation and technological characteristics to the L-Varlock Lumbar Cage (K080537) and the Caliber Spacer (K102293).

#### Description of the Device Subject to Premarket Notification

The Opticage Interbody Fusion Device is a lumbar intervertebral body fusion device manufactured from implant grade titanium alloy. The Opticage Interbody Fusion Device consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the device. The device is available in a single configuration that ranges in length from 29mm (closed) to 21mm (expanded) and ranges in nominal height from 9mm (closed) to 14mm (expanded). The top and bottom of the device are fenestrated and contain openings to enhance bony in growth. The Opticage Interbody Fusion Device is provided non-sterile, for single use only.

#### Indication for Use

The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients

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may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

## Technical Characteristics

The Opticage Interbody Fusion device and the referenced predicates are all intended for use as intervertebral body fusion devices. The Opticage Interbody Fusion Device and the predicates are fabricated from well-known osteo-compatible materials with a long history of biocompatibility. The Opticage Interbody Fusion Device and the predicates are used as implantable spacers to provide structural support and maintain height between the adjacent vertebrae. All devices are designed to be used in conjunction with autogenous bone graft. All devices require the use of commercially available supplemental internal spinal fixation systems. All devices share the same geometry, rectangular box shaped with openings and toothed surface on the top and bottom. All devices are expanded by means of a rotational thread (screw) after insertion.

### Performance Data

All necessary performance testing, has been completed for the Opticage Interbody Fusion Device including those identified in ASTM F2077 (static and dynamic compression, static compression shear, static and torsional loading paradigms), subsidence per ASTM F2267, expulsion, and evaluation of wear debris/particulates to assure substantial equivalence to the predicate devices.

### Basis for Determination of Substantial Equivalence

Upon reviewing the performance data provided in this submission and comparing intended use, design, materials, principle of operation and overall technological characteristics, the Opticage Interbody Fusion Device is determined by Interventional Spine, Inc., to be substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

JAN 2 0 2012

Interventional Spine, Incorporated % Ms. Jane Metcalf Vice President of Quality Assurance, Regulatory and Clinical Affairs 13700 Alton Parkway, Suite 160 Irvine, California 92618

Re: K113527

Trade/Device Name: Opticage Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 27, 2011 Received: November 30, 2011

Dear Ms. Metcalf:

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

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Page 2 - Ms. Jane Metcalf

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 go to for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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.

ely yours,

N. Melkerson

Mark N. Melkerson Director

· Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

### 510(k) Number (if known):

## Device Name: Opticage™ Interbody Fusion Device

Indications for Use:

The Onticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KII3527 510(k) Number_