MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM

K071380 · Alphatec Spine, Inc. · NKB · Aug 20, 2007 · Orthopedic

Device Facts

• Record ID: K071380
• Device Name: MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
• Applicant: Alphatec Spine, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Aug 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods - l Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - Spondylolisthesis - Spinal Stenosis - Fracture/Dislocation - Atlanto/Axial fracture with instability - Revision of previous cervical spine surgery - Tumors

Device Story

SOLANAS III Posterior Stabilization System is a spinal fixation implant system; provides mechanical stability to cervical and thoracolumbar spine (C1-T3). Components include hooks, polyaxial screws, and rods; allows linkage to Zodiac Polyaxial Spinal Fixation System via specialized connectors. Used by surgeons in clinical/OR settings to treat spinal pathologies including DDD, fractures, and tumors. Device provides rigid fixation to facilitate bone fusion; intended for removal post-fusion. Mechanical performance validated via bench testing.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical and dynamic testing demonstrated performance equivalent to predicate.

Technological Characteristics

Spinal fixation system consisting of hooks, polyaxial screws, and rods. Designed for C1-T3 stabilization. Components compatible with Zodiac Polyaxial Spinal Fixation System via axial, parallel, or transitional rod connectors. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring cervical and thoracolumbar (C1-T3) spinal stabilization due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, revision of previous cervical surgery, or tumors. Hook components for C1-C7; polyaxial screws for T1-T3 thoracic conditions only (not for cervical spine). Device must be removed after solid fusion.

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

• SOLANAS™ Posterior Stabilization System (K052201)

Reference Devices

• Zodiac Polyaxial Spinal Fixation System

Submission Summary (Full Text)

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## 510(k) SUMMARY

# SOLANAS ™ Posterior Stabilization System 510(k) SUMMARY May 2007

AUG 2 0 2007

| Company: | Alphatec Spine, Inc.<br>2051 Palomar Airport Road#100<br>Carlsbad, CA 92011 USA<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula Morgan, Director of Regulatory Affairs/Compliance |
| Trade/Proprietary Name: | SOLANAS ™ Posterior Stabilization System |
| Common Name: | Spinal Interlaminal Orthosis Fixation |
| Classification Name: | Spinal Interlaminal Orthosis Fixation (888.3050) |
| | Orthosis, Spinal Pedicle Fixation for Degenerative<br>Disc Disease (888.3070) |

# Product Description:

The SOLANAS III™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).

# Indications for Use:

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods

- l Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- 피 Spinal Stenosis
- 트 Fracture/Dislocation
- 트 Atlanto/Axial fracture with instability

page 1 of ?...

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# 1071380

- 트 Revision of previous cervical spine surgery
- I Tumors

# Substantial Equivalence:

The SOLANAS III™ Posterior Stabilization System is substantially equivalent to the following predicate devices:

Trade/Proprietary Name SOLANAS™ Posterior Stabilization System

Manufacturer Alphatec Spine, Inc. Clearance K052201

## Performance Data:

Mechanical and dynamic testing of the posterior stabilization system was performed. The test results demonstrate that the mechanical performance of the SOLANAS III™ Posterior Stabilization System is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2007

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

Re: K071380

Trade/Device Name: SOLANASTM Posterior Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNI Dated: July, 30, 2007 Reccived: August 1, 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 [phone]. 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 vours.

Barbara Buchner

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): K071380

Device Name: SOLANAS TM Posterior Stabilization System

#### Indications for Use:

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods

- l Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- 트 Spondylolisthesis
- . Spinal Stenosis
- 트 Fracture/Dislocation
- Atlanto/Axial fracture with instability
- 트 Revision of previous cervical spine surgery
- 트 Tumors

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use

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

urrence of CDRH, Office of Device Evaluation (ODE)

Qarban Brielm Pfaixm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Numbe