ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

K042673 · Alphatec/Nexmed · KWP · Oct 27, 2004 · Orthopedic

Device Facts

• Record ID: K042673
• Device Name: ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
• Applicant: Alphatec/Nexmed
• Product Code: KWP · Orthopedic
• Decision Date: Oct 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. 1) The ZODIAC™ Polyaxial Spinal Fixation System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for: a. Patients having fractures of the thoracic and lumbar spine. b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). 2) The ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). 3) In addition, the ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw fixation system is intended for: a. Patients receiving only autogenous bone graft. b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. 4) The ZODIAC™ Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for: a. Patients having fractures of thoracic and lumbar spine. b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

Device Story

ZODIAC™ Polyaxial Spinal Fixation System; implantable spinal construct for rigid fixation. Components include pedicle screws, hooks, and rods. Used by surgeons in clinical settings to stabilize spine during fusion procedures. Device provides mechanical support to facilitate bone fusion; removed after solid fusion mass development. Benefits include stabilization of spinal segments in patients with fractures, deformities, or degenerative conditions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Implantable spinal fixation system. Materials: Titanium alloy (Ti-6AI-4V ELI, ASTM F 136) and commercially pure titanium (ASTM G67). Polyaxial design. Mechanical/dynamic testing performed.

Indications for Use

Indicated for patients with thoracic/lumbar spine fractures, spinal deformities (idioscoliosis, neuromuscular scoliosis, kyphoscoliosis), spondylolisthesis (isthmic, degenerative, acute pars fracture), degenerative spondylolisthesis with neurologic impairment, dislocation, spinal tumor, or pseudoarthrosis. Specific use for severe grade 3-4 spondylolisthesis at L5-S1 with autogenous bone graft. Hook use limited to T7-L5; sacral screws limited to sacrum.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Submission Summary (Full Text)

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OCT 2 7 2004

### K042673 - 510(k) SUMMARY ZODIAC™ Polyaxial Spinal Fixation System September 2004 Page 1 of 2

- Alphatec Manufacturing, Inc. Company: 6110 Corte Del Cedro Carlsbad, CA 92009 USA Telephone: [phone] Fax: [phone]

| Contact Person: | Ellen Yarnall, Director of Regulatory Affairs |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Proprietary Name: | ZODIAC™ Polyaxial Spinal Fixation System |
| Common Name: | Pedicle Screw Spinal System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis (888.3050)<br>Spondylolisthesis Spinal Fixation Device (888.3070<br>Pedicle Screw Spinal System (888.3070) |

#### Product Description:

The ZODIAC™ Polyaxial Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti-6AI-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.

#### Indications for Use:

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

- 1) The ZODIAC™ Polyaxial Spinal Fixation System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
- a. Patients having fractures of the thoracic and lumbar spine.
- b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).

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# K042673 - 510(k) SUMMARY ZODIAC™ Polyaxial Spinal Fixation System September 2004 Page 2 of 2

- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
- 2) The ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
- 3) In addition, the ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw fixation system is intended for:
- a. Patients receiving only autogenous bone graft.
- b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
- 4) The ZODIAC™ Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
- a. Patients having fractures of thoracic and lumbar spine.
- b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
- c. Patients having spondylolisthesis (i.e., isthmic spondvlolisthesis. degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

# Substantial Equivalence:

Documentation was provided that demonstrates that the ZODIAC™ Polyaxial Spinal Fixation System is substantially equivalent to other pedicle screw systems currently on the market.

# Performance Data:

Mechanical and dynamic testing was performed. Test results demonstrated that the mechanical performance of the ZODIAC™ Polyaxial Spinal Fixation System is at least comparable to, if not better than, those of the predicate devices.

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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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 2004

Ms. Ellen A. Yarnall Director, Regulatory Affairs Alphatec Manufacturing Incorporated 6110 Corte Del Cedro Carlsbad, California 92009

Re: K042673

Trade/Device Name: ZODIAC™ Polyaxial Spinal Fixation System Regulation Numbers: 21 CFR 888.3050 and 21 CFR 888.3070 (b) (1) Regulation Names: Spinal interlaminal fixation orthosis and Pedicle screw spinal system Regulatory Class: II Product Codes: KWP, MNI, MNH Dated: September 29, 2004 Received: September 29, 2004

Dear Ms. Yarnall:

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 (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. Ellen A. Yarnall

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Millburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510(k) Number (if known): K042673

Device Name: ZODIAC™ Polyaxial Spinal Fixation System

#### Indications for Use:

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

- 1) The ZODIAC™ Polyaxial Spinal Fixation System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
- Patients having fractures of the thoracic and lumbar spine. a.
- Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with b. associated paralysis or spasticity).
- Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, ﻥ ﻧ and acute pars fracture allowing spondylolisthesis).
- 2) The ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
- 3) In addition, the ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw fixation system is intended for:
- a. Patients receiving only autogenous bone graft.
- b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
- 4) The ZODIAC™ Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
- Patients having fractures of thoracic and lumbar spine. a.
- Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or b. kyphoscoliosis with associated paralysis or spasticity).
- Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses ். and acute pars fracture allowing spondylolisthesis).

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The Counter Use<br>(21 CFR 801 Subpart C) | |
|-------------------------------------------------|---|--------|------------------------------------------------|--|
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(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (Division Sign-Off)

Division of General, Restorative, and Neurological Devices

K042673