SOLANAS POSTERIOR STABILIZATION SYSTEM

K131119 · Alphatec Spine, Inc. · NKB · May 21, 2013 · Orthopedic

Device Facts

• Record ID: K131119
• Device Name: SOLANAS POSTERIOR STABILIZATION SYSTEM
• Applicant: Alphatec Spine, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: May 21, 2013
• 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 development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws and offset connectors are limited to the thoracic spine (T1-T3) in treating thoracic conditions only. These screws and offset connectors are not intended to be placed 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 1. Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. 2. Spondylolisthesis 3. Spinal stenosis 4. Fracture/Dislocation 5. Atlanto/Axial fracture with instability 6. Revision of previous cervical spine surgery 7. Tumors

Device Story

Solanas Posterior Stabilization System provides temporary internal fixation and stabilization for spinal deformities during bone graft healing/fusion. System components include titanium alloy bone screws, hooks, rods, and bridge assemblies. Hooks attach to the lamina; rods connect via set screws and collars. Used by surgeons in clinical settings to stabilize cervical, cervico-thoracic, and upper thoracic spine (C1-T3). Components may link to Zodiac Polyaxial spinal fixation system. Device is temporary and intended for removal post-fusion.

Clinical Evidence

Bench testing only. Mechanical characteristics evaluated per ASTM F1798 static anterior/posterior property measurements. Results demonstrated substantial equivalence to predicate device.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI, ASTM F136) with electrolytic conversion coating. System includes screws, rods, hooks, and connectors. Hooks feature 7mm and 8mm blades. Mechanical stabilization via posterior rod fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring posterior spinal stabilization for degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, revision surgery, or tumors. Hook components for C1-C7; polyaxial pedicle screws and offset connectors for T1-T3 thoracic conditions only. Not for cervical placement of screws/connectors. Intended for removal after 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)
• Modification to Solanas Posterior Stabilization System (K071380)

Reference Devices

• Zodiac Polyaxial spinal fixation system

Submission Summary (Full Text)

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# K131119 :: page 1 of 2

## MAY 2 1 2013

## 510(k) Summary

Solanas® Posterior Stabilization System Date Prepared: April, 19th, 2013

| I | Company: | Alphatec Spine, Inc.<br>5818 El Camino Real<br>Carlsbad, CA 92008.<br>USA |
|-------|------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| II. | Contact: | Trevor J. Denbo<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| III. | Product Trade Name: | Solanas Posterior Stabilization System |
| IV. | Common Name: | Pedicle screw spinal system |
| V. | Classification Name: | Pedicle screw spinal system |
| VI. | Regulation Number: | 888.3050, 888.3070 |
| VII. | Classification Product Code: | KWP, MNI, NKB |
| VIII. | Predicate Devices: | Solanas Posterior Stabilization System, K052201<br>and Modification to Solanas Posterior<br>Stabilization System, K071380 |

#### IX. Description:

The Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graff healing and/or fusion mass development. Device implants include a range of sizes of bone screws, hooks, rods and bridge assemblies to provide the versatility required for the specific conditions listed in the indications.

The implants are manufactured from surgical grade titanium alloy (Ti-6AI-4V, ASTM F 136) with an electrolytic conversion coating. All hook components are intended for fixation/attachment to the cervical spine only (CI-C7). It is intended that the implants be removed after successful fusion.

Special 510(k)

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### X. Indications for Use:

It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws and offset connectors are limited to the thoracic spine (T1-T3) in treating thoracic conditions only. These screws and offset connectors are not intended to be placed 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

- 1. Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- 2. Spondylolisthesis
- 3. Spinal stenosis
- 4. Fracture/Dislocation
- 5. Atlanto/Axial fracture with instability
- 6. Revision of previous cervical spine surgery
- 7. Tumors

#### XI. Summary of the Technological Characteristics:

The technological characteristics, materials, and indications for use of Solanas® Posterior Stabilization System are substantially equivalent to the previously cleared predicate. The subject device differs from the predicate in that the modified hooks contain 7mm and 8mm blades, which is larger than the predicate.

The Solanas Posterior Stabilization System is a rod system designed to improve the stability of the cervical, cervico-thoracic and upper thoracic spine from C1-T3. This titanium alloy (Ti6Al-4V ELI, ASTM F136) system is simple in design and in its application of posterior rod fixation. It contains integrated functioning screws, rods, hooks, and connectors. The laminar hooks are an integral part of this system providing stabilization to the cervical (C1-C7) portion of the spine. These hooks attach to the lamina via the blade portion of the hook on one end and to a rod via a set screw and collar connection on the other end.

#### XII. Discussion of the Non-clinical Testing:

Mechanical characteristics were examined in accordance to the static anterior/posterior mechanical property measurements of a subassembly as outlined in ASTM F1798. This performance testing was performed comparing the subject and predicate devices per the recognized consensus standards and per the guidance document. Guidance for Industry and FDA Staff: Spinal System 510/k)s (2004). This test produced acceptable results and demonstrates that the Solanas Posterior Stabilization System is substantially equivalent to the predicate device.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002

### Letter Dated: May 21, 2013

Alphatec Spine, Incorporated % Mr. Trevor J. Denbo Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K13119

Trade/Device Name: SOLANAS® Posterior Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI. KWP Dated: April 19, 2013 Received: April 22, 2013

### Dear Mr. Denbo:

. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 – Mr. Trevor J. Denbo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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,

Laurence Coyne -A

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

Enclosure

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## Indications for Use

### K131119 510(k) Number (if known):

Device Name: SOLANAS® Posterior Stabilization System

Indications For Use:

It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws and offset connectors are limited to the thoracic spine (T1-T3) in treating thoracic conditions only. These screws and offset connectors are not intended to be placed 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

- 1. Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- 2. Spondylolisthesis
- 3. Spinal stenosis
- 4. Fracture/Dislocation
- 5. Atlanto/Axial fracture with instability
- 6. Revision of previous cervical spine surgery
- 7. Tumors

ਮ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131119

Solanas Posterior Stabilization System

Special 510(k)

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