NOVEL CERVICAL SPINAL SPACER SYSTEM

K081730 · Alphatec Spine, Inc. · ODP · Sep 19, 2008 · Orthopedic

Device Facts

• Record ID: K081730
• Device Name: NOVEL CERVICAL SPINAL SPACER SYSTEM
• Applicant: Alphatec Spine, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Sep 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

When used as a Vertebral Body Replacement When used as a vertebral body replacement, the Novel® Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel® Spinal Spacer System is intended for use with supplemental spinal fixation system. Specifically the Novel® Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the Novel® Spinal Spacer System is intended for use with allograft. When used as a Lumbar Intervertebral Body Fusion When used as a lumbar Intervertebral Body Fusion, the Novel® Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft. When used as a Cervical Intervertebral Body Fusion When used as a cervical intervertebral body fusion device, the Novel® Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system.

Device Story

Implantable spinal spacer system; manufactured from PEEK and titanium alloy; available in various shapes/sizes. Used as vertebral body replacement (thoracolumbar) or intervertebral body fusion device (cervical/lumbar). Requires supplemental spinal fixation (e.g., Alphatec Zodiac or Mirage systems) and bone graft (allograft or autogenous). Implanted by surgeons via open, anterior approach. Provides structural support to spinal column; facilitates fusion; restores disc height/stability. Benefits patients by addressing instability, pain, and degeneration.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: PEEK and titanium alloy. Form factor: Various shapes and sizes for anatomical fit. Energy source: None (passive implant). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two levels (L2-S1) or one level (C2-T1), or patients with collapsed/unstable vertebral bodies (T1-L5) due to tumor or trauma. Requires six months of failed non-operative treatment for DDD.

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.

Reference Devices

• Alphatec Zodiac Polyaxial Spinal Fixation System
• Alphatec Mirage Top Tightening Spinal System

Submission Summary (Full Text)

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## 510(k) SUMMARY

## Novel® Spinal Spacer System 510(k) SUMMARY JUNE 2008

SEP 1 9 2008

| Company: | Alphatec Spine, Inc.<br>2051 Palomar Airport Road #100<br>Carlsbad, CA 92011 USA<br>Direct: [phone]<br>Fax: [phone] |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Stanners, Regulatory Affairs Specialist II |
| Trade/Proprietary Name: | Novel® Spinal Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Orthosis, Spinal Intervertebral Fusion with Bone Graft, Cervical |
| Classification Number(s)/Product Code(s): | 21 CFR 888.3080 (ODP) |

## Product Description:

The Novel® Spinal Spacer System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit individual pathology and anatomical conditions of the patient.

## Indications for Use:

## When used as a Vertebral Body Replacement

When used as a vertebral body replacement, the Novel® Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel® Spinal Spacer System is intended for use with supplemental spinal fixation system. Specifically the Novel® Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the Novel® Spinal Spacer System is intended for use with allograft.

## When used as a Lumbar Intervertebral Body Fusion

When used as a lumbar Intervertebral Body Fusion, the Novel® Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic

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back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.

## When used as a Cervical Intervertebral Body Fusion

When used as a cervical intervertebral body fusion device, the Novel® Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system.

## Substantial Equivalence:

Data was provided which demonstrated the Novel® Spinal Spacer System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material and function.

## Performance Data:

The test results demonstrate that the mechanical performance of the Novel® Spinal Spacer System is substantially equivalent to the predicate device.

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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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

SEP 1 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alphatec Spine, Inc. % Ms. Mary Stanners Regulatory Affairs Specialist II 5818 El Camino Real Carlsbad, California 92008

Re: K081730

Trade/Device Name: Novel® Spinal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: September 12, 2008 Received: September 15, 2008

Dear Ms. Stanners:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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#### Page 2 - Ms. Mary Stanners

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

#### 510(k) Number (if known): K081730

### Device Name: Novel® Spinal Spacer System

#### Indications for Use:

### When used as a Vertebral Body Replacement

When used as a vertebral body replacement, the Novel® Spinal Spacer System is intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged or unstable vertebral body due to trauma (i.e. fracture). The Novel® Spinal Spacer System is intended for use with supplemental spinal fixation system. Specifically the Novel® Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the Novel® Spinal Spacer System is intended for use with allograft.

#### When used as a Lumbar Intervertebral Body Fusion

When used as a lumbar Intervertebral Body Fusion, the Novel® Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.

#### When used as a Cervical Intervertebral Body Fusion

When used as a cervical intervertebral body fusion device, the Novel® Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system.

Over-The Counter Use OR Prescription Use (Per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative, and Neurological Devices

510(k) Number L081130

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