ICON POLYAXIAL PEDICLE SCREW SYSTEM

K033090 · Alphatec Mfg., Inc. · KWP · Mar 26, 2004 · Orthopedic

Device Facts

• Record ID: K033090
• Device Name: ICON POLYAXIAL PEDICLE SCREW SYSTEM
• Applicant: Alphatec Mfg., Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• 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-L.5. Sacral screw indications are limited to the sacrum only. 1) The ZODIAC Polyaxial Pedicle Screw 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 Pedicle Screw 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 Pedicle Screw 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 Pedicle Screw 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 Pedicle Screw System is a spinal fixation construct consisting of titanium alloy screws, rods, and hooks. Designed for surgical implantation in the thoraco-lumbo-sacral spine to facilitate stabilization during fusion. Components are assembled intraoperatively by surgeons to create a rigid construct. System facilitates optimal screw and rod placement. Device is temporary; intended for removal following development of solid fusion mass. Benefits include stabilization of spinal segments in patients with fractures, deformities, or degenerative conditions.

Clinical Evidence

Bench testing only. Mechanical and dynamic testing performed to evaluate structural integrity and performance compared to predicate devices.

Technological Characteristics

Constructed from titanium alloy Ti6Al-4V ELI (ASTM F 136) and commercially pure titanium Grade 4 (ASTM G67). Polyaxial screw design. System includes rods, screws, and hooks for spinal fixation.

Indications for Use

Indicated for patients with thoracic/lumbar fractures, spinal deformities (scoliosis, kyphoscoliosis), spondylolisthesis (isthmic, degenerative, acute pars fracture), spinal tumors, dislocations, or failed previous fusion. Specific use for pedicle screw fixation in thoraco-lumbo-sacral region, or hook/sacral screw fixation. Includes patients with severe L5-S1 spondylolisthesis (grade 3-4) receiving autogenous bone graft. Contraindicated for permanent implantation; device must be removed after solid fusion.

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.

Predicate Devices

• Optima Spinal System (K031585)
• Global Spinal Fixation System (K001668)
• Moss-Miami Spinal System (K982320)
• Universal Spine System (K022949)

Submission Summary (Full Text)

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K033090
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# MAR 2 6 2004

#### ZODIAC Polyaxial Pedicle Screw System 510(k) SUMMARY November 2003

- Company: Alphatec Manufacturing, Inc. 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 Pedicle Screw System

Common Name: Pedicle Screw Spinal System

- Classification Name: Spinal Interlaminal Fixation Orthosis (888,3050) Spondylolisthesis Spinal Fixation Device (888,3070) Pedicle Screw Spinal System (888.3070)
## Product Description:

The ZODIAC Polyaxial Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigios annal construct. System components are manufactured from titanium alloy, Tri6Al-4V ELI (ASTM F 136). System rods are available in titanium allow or commercially pure titanium, CP Grade 4 (ASTM G67). The ZODIAC Polyaxial Pedicle Screw System is designed to facilitate optimal screw and rod placement.

#### 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-L.5. Sacral screw indications are limited to the sacrum only.

- 1) The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended a noon
- 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).

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## ZODIAC Polyaxial Pedicle Screw System 510(k) SUMMARY November 2003

2 Of 2

- 2) The ZODIAC Polyaxial Pedicle Screw 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 Pedicle Screw 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 Pedicle Screw 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).

#### Substantial Equivalence:

The ZODIAC Polyaxial Pedicle Screw System is substantially equivalent to the following predicate devices:

| Trade/Proprietary Name | Manufacturer | Clearance |
|-------------------------------|--------------|-----------|
| Optima Spinal System | U&I America | K031585 |
| Global Spinal Fixation System | U&I America | K001668 |
| Moss-Miami Spinal System | Depuy Inc. | K982320 |
| Universal Spine System | Synthes | K022949 |

#### Performance Data:

Mechanical and dynamic testing of the ZODIAC Polyaxial Pedicle Screw System was performed. The test results demonstrate that the mechanical performance of the ZODIAC Polyaxial Pedicle Screw 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 and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

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

Re: K033090

> Trade Name: ZODIAC Pedicle Screw System Regulation Number: 21 CFR 888.3050 and 888.3070 (b) (1) Regulation Name: Spinal Interlaminal Fixation Orthosis and Pedicle Screw Spinal System Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: January 8, 2004 Received: January 9, 2004

Dear Ms. Yarnell:

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.

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Page 2 - Ms. Ellen Yarnell

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. 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. Milkum

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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## MAR 2 6 2004

#### 510(k) Number (if known): K033090

## Device Name: ZODIAC Polyaxial Pedicle Screw System

#### Indications for Use:

lt is intended that this device, in any system configuration be removed after it is intended that this dones, in any system indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

- 1) The ZODIAC Polyaxial Pedicle Screw 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 Soliobio, or Ryphoondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
- 2) The ZODIAC Polyaxial Pedicle Screw 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 intentod for abgonent, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
- 3) In addition, the ZODIAC Polyaxial Pedicle Screw 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 Pedicle Screw 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).

Mark Milan

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

K033090

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- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, r ationto having spondylistheses and acute pars fracture allowing spondylolisthesis).
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Mark N. Mikkelson

On), Restorative, Division of Ge Division of General ,
and Neurological Devices KO 33090

**510(k) Number**