ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

K093077 · Alphatec Spine, Inc. · MNI · Dec 23, 2009 · Orthopedic

Device Facts

• Record ID: K093077
• Device Name: ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
• Applicant: Alphatec Spine, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. 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-iliac screw indications are limited to the sacrum-iliac crest only.

Device Story

Zodiac® Polyaxial Spinal Fixation System is a posterior spinal fixation device used to stabilize the spine during bone graft fusion. Components include polyaxial screws, hooks, and sacral-iliac screws. Surgeons implant the system in the thoraco-lumbo-sacral iliac region to correct deformities, fractures, and pathologies. The device provides mechanical stabilization; it is intended for removal after solid fusion is achieved. The system is used in an operating room setting by orthopedic or neurosurgeons. It benefits patients by providing structural support to the spine, facilitating healing and correction of spinal alignment.

Clinical Evidence

Bench testing only. Mechanical and dynamic testing was performed to verify the performance of the additional components and demonstrate substantial equivalence to the predicate devices.

Technological Characteristics

Posterior spinal fixation system consisting of polyaxial screws, hooks, and sacral-iliac screws. Designed for thoraco-lumbo-sacral iliac fixation. Mechanical stabilization principle. No software or energy source components.

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, and failed previous fusion (pseudoarthrosis). Includes patients receiving autograft/allograft bone and those with severe grade 3 or 4 spondylolisthesis at L5-S1.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• Zodiac® Polyaxial Spinal Fixation System (K033090)
• Zodiac® Polyaxial Spinal Fixation System (K042673)
• Zodiac® Stainless Steel Spinal Fixation System (K051286)
• Zodiac® 4.0 Polyaxial Spinal Fixation System (K071890)

Submission Summary (Full Text)

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Zodiac® Polyaxial Spinal Fixation System

510(k) Number TBD

K093077

page 1 of 2

Image /page/0/Picture/2 description: The image shows the words "Alphatec Spring" in a stylized font. The text is black and appears to be slightly blurred. The word "Alphatec" is above the word "Spring", and there is some additional text above "Alphatec" that is difficult to read.

DEC 2 3 2009

### 510(k) SUMMARY

Zodiac® Polyaxial Spinal Fixation System 510(k) SUMMARY September 2009

Company:

Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Direct: [phone] Fax: [phone]

| Contact Person: | Cheryl Allen, Regulatory Affairs Submissions Specialist |
|-------------------------|----------------------------------------------------------------------|
| Trade/Proprietary Name: | Zodiac® Polyaxial Spinal Fixation System |
| Common Name: | Pedicle Screw Spinal Device |
| Classification Names: | Spinal Interlaminal Fixation Orthosis<br>Pedicle Screw Spinal System |

#### Classification Number(s)/Product Code(s) : 21 CFR 888.3050, 888.3070 KWP, MNI, MNH

#### Product Description:

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

### Indications for Use:

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

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-iliac screw indications are limited to the sacrum-iliac crest only.

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Zodiac® Polyaxial Spinal Fixation System

**510(k) Number** TBD
K093077
page 2 of 2

### Alonatec Scine

I . The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac 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 iliac 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 system . is intended for:

a. Patients receiving autograft or allograft bone.

b. Patient having the device fixed or attached to the lumbar and sacral iliac 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 scollosis,

kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

# Substantial Equivalence:

The Zodiac® Polyaxial Spinal Fixation System additional components are substantially equivalent to the following predicate device:

| Trade/Proprietary/Model Name | Manufacturer | 510(k) No. |
|------------------------------------------------|----------------------|------------|
| Zodiac® Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | K033090 |
| Zodiac® Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | K042673 |
| Zodiac® Stainless Steel Spinal Fixation System | Alphatec Spine, Inc | K051286 |
| Zodiac® 4.0 Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | K071890 |

# Performance Data:

Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. The testing demonstrated that additional components are substantially equivalent to the predicate Zodiac 9 Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be a family.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Alphatec Spine, Inc. % Ms. Cheryl Allen Regulatory Affairs Submission Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K093077

Trade/Device Name: Zodiac® Polyaxial Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWP Dated: November 20, 2009 Received: November 23, 2009

Dear Ms. Allen:

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.

DEC 2 3 2009

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); 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.

11 11

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# Page 2 - Ms. Cheryl Allen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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Zodiac® Polyaxial Spinal Fixation System

510(k) Number TBD

Image /page/4/Picture/2 description: The image shows the logo for "Alphatec Spine". The logo consists of a stylized letter "U" above the words "Alphatec Spine". The text is in a bold, slightly distressed font, giving it a textured appearance. The overall design is simple and recognizable.

K093077 page 1 of 2

#### INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Zodiac® Polyaxial Spinal Fixation System

### Indications for Use:

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

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-iliac screw indications are limited to the sacrum-iliac crest only.

1. The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac 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 iliac 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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Image /page/5/Picture/1 description: The image shows the logo for "Alphatec Spine". The logo features a stylized Greek letter alpha above the company name. The text "Alphatec Spine" is in a bold, slightly italicized font.

3. In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving autograft or allograft bone.

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (LS-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,

kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

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 Surgical, Orthopedic, and Restorative Devices

510(k) Number K093077