ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM

K072081 · Alphatec Spine, Inc. · KWP · Oct 24, 2007 · Orthopedic

Device Facts

• Record ID: K072081
• Device Name: ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
• Applicant: Alphatec Spine, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Oct 24, 2007
• 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-L5. Sacral screw indications are limited to the sacrum only. 1) The Zodiac DynaMo Semi-Rigid Spinal 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 DynaMo Semi-Rigid Spinal 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 DynaMo Semi-Rigid Spinal 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 DynaMo Semi-Rigid Spinal 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

Top-loading anterior/posterior spinal fixation system; consists of implantable components (hooks, sacral screws, pedicle screws) assembled to create rigid spinal construct; used in thoraco-lumbo-sacral region; intended for temporary stabilization until solid fusion mass develops; device removed after fusion; operated by surgeons in clinical/OR setting; provides mechanical stabilization to spine; aids in correction of deformities and stabilization of fractures/spondylolisthesis; benefits patient by facilitating spinal fusion and structural support.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical and dynamic testing demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Top-loading anterior/posterior spinal fixation system; components include hooks, sacral screws, and pedicle screws; semi-rigid construct; intended for temporary implantation.

Indications for Use

Indicated for patients with thoracic/lumbar fractures, spinal deformities (idioscoliosis, neuromuscular scoliosis, kyphoscoliosis with paralysis/spasticity), spondylolisthesis (isthmic, degenerative, acute pars fracture), degenerative spondylolisthesis with neurologic impairment, dislocation, spinal tumor, or failed fusion. Includes severe grade 3/4 spondylolisthesis at L5-S1. Requires autogenous bone graft for specific pedicle screw applications.

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

• Moss-Miami Spinal System (K030383)

Submission Summary (Full Text)

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# KOJ 2081

# 510(k) SUMMARY

# Zodiac DynaMo Semi-Rigid Spinal System 510(k) SUMMARY July 2007

OCT 2 4 2007

| Company: | Alphatec Spine, Inc.<br>2051 Palomar Airport Road#100<br>Carlsbad, CA 92011 USA<br>Direct: [phone]<br>Fax: [phone] |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula Morgan, Director of Regulatory Affairs & Compliance |
| Trade/Proprietary Name: | Zodiac DynaMo Semi-Rigid Spinal System |
| Common Name: | Pedicle Screw Spinal Device |
| Classification Name: | Spinal Interlaminal Fixation Orthosis<br>Pedicle Screw Spinal System |

#### Product Description:

The Zodiac DynaMo Semi-Rigid Spinal System is a top loading anterior/posterior spinal fixation system consisting of various types and sizes of implantable components that are assembled to create a rigid spinal construct.

#### 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 DynaMo Semi-Rigid Spinal 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.

- Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis b. with associated paralysis or spasticity).
- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
- 2) The Zodiac DynaMo Semi-Rigid Spinal 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).

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- 3) In addition, the Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw fixation system is intended for:
- Patients receiving only autogenous bone graft. a.
- 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 DynaMo Semi-Rigid Spinal System , when used as a laminar hook and bone screw system is intended for:
- a. Patients having fractures of thoracic and lumbar spine.
- 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 C. spondylolistheses and acute pars fracture allowing spondylolisthesis).

# Substantial Equivalence:

The Zodiac DynaMo Semi-Rigid Spinal System is substantially equivalent to the following predicate devices:

Trade/Proprietary Name Moss-Miami Spinal System Manufacturer DePuy Spine, Inc. Clearance K030383

### Performance Data:

Mechanical and dynamic testing of the semi-rigid spinal fixation system was performed. The test results demonstrate that the mechanical performance of the Zodiac DynaMo Semi-Rigid Spinal System is substantially equivalent to the predicate device.

Fong 2.4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized human figure with three faces in profile, representing health and well-being. The logo is rendered in black and white.

Public Health Service

0CT 2 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alphatec Spine, Inc. % Ms. Paula Morgan Director of Regulatory Affairs & Compliance 2051 Palomar Airport Road, #100 Carlsbad, California 92011

Re: K072081

Trade/Device Name: Zodiac DynaMo Semi-Rigid Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: July 27, 2007 Received: July 30, 2007

Dear Ms. Morgan:

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. Paula Morgan

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 240-276-3474. 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.

Sincerely yours,

Mark A. Milherson

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): TBD

Device Name: Zodiac DynaMo Semi-Rigid Spinal 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 DynaMo Semi-Rigid Spinal 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 DynaMo Semi-Rigid Spinal 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 DynaMo Semi-Rigid Spinal 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.

Prescription Use X (Per 21 CFR 801.109)

OR
Mark A. Milleson Over The Counter Use

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
K072

(PLEASE DO NOT WRITE BELOW NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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- 4) The Zodiac DynaMo Semi-Rigid Spinal System , when used as a laminar hook and bone screw system is intended for:
- a. Patients having fractures of thoracic and lumbar spine.
- 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 c. spondylolistheses and acute pars fracture allowing spondylolisthesis).

Mark A. Milkerson

Division Sign. Restorative, Division of Ge and Ne

210(k) 1