NOVEL ALIF SPINAL SPACER SYSTEM

K090782 · Alphatec Spine, Inc. · MAX · Apr 22, 2009 · Orthopedic

Device Facts

• Record ID: K090782
• Device Name: NOVEL ALIF SPINAL SPACER SYSTEM
• Applicant: Alphatec Spine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 22, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

When used as an Intervertebral Body Fusion device, the Novel ALIF 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 ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft. When used as a Vertebral Body Replacement device, the Novel ALIF 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 ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.

Device Story

Implantable spinal spacer system; manufactured from PEEK and titanium alloy; available in various shapes/sizes. Used in spinal fusion or vertebral body replacement procedures. Operates as mechanical support for spine; requires supplemental fixation (e.g., Alphatec Zodiac or Mirage systems) and bone graft (autogenous for fusion, allogenous for replacement). Used by surgeons in clinical/OR settings to restore spinal stability in patients with DDD, tumor, or trauma. Provides structural support to facilitate fusion or replace damaged vertebral bodies.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: PEEK and titanium alloy. Form factor: Various shapes and sizes for spinal implantation. 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 contiguous levels (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis, requiring spinal fusion after 6 months of failed non-operative treatment. Also indicated for thoracolumbar (T1-L5) vertebral body replacement due to tumor or trauma (fracture).

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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K090782

## 510(k) SUMMARY

# APR 2 2 2009

## Novel® ALIF Spinal Spacer System 510(k) SUMMARY March 2009

| Company: | Alphatec Spine, Inc.<br>5818 El Camino Real<br>Carlsbad, CA 92008 USA<br>Direct: [phone]<br>Fax: [phone] |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Stanners, Regulatory Affairs Specialist II |
| Trade/Proprietary Name: | Novel® ALIF Spinal Spacer System |
| Common Name: | Intervertebral Body Fusion Device<br>Vertebral Body Replacement Device |
| Classification Name: | Intervertebral Body Fusion Device<br>Spinal Intervertebral Body Fixation Orthosis |
| Classification Number(s)/Product Code(s): | 21 CFR 888.3080 (MAX)<br>21 CFR 888.3060 (MQP) |

### Product Description:

The Novel® ALIF 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 an Intervertebral Body Fusion device, the Novel ALIF 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 ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.

When used as a Vertebral Body Replacement device, the Novel ALIF 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 ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.

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K090782

## Substantial Equivalence:

Data was provided which demonstrated the Novel ALIF 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 ALIF Spinal Spacer System is substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The seal is simple and iconic, representing the department's role in promoting health and well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090782

Trade/Device Name: Novel® ALIF Spinal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MOP Dated: March 20, 2009 Received: March 23, 2009

APR 2 2 2009

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.

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 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.

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Page 2- Ms. Mary Stanners

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

erely yours,

k N. Melkerson

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): K090782

## Device Name: Novel® ALIF Spinal Spacer System

### Indications for Use:

#### Intervertebral Body Fusion

When used as an Intervertebral Body Fusion device, the Novel ALIF 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 ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.

### Vertebral Body Replacement

When used as a Vertebral Body Replacement device, the Novel ALIF 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 ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically-the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.

Prescription Use X (Per 21 CFR 801.109)

OR ·

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off Division of General, Restorative and Neurological Devices

**510(k) Number** k090782
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