SOLAS ANATOMIX SPINAL SYSTEM

K083178 · Biotechni America Spine Group, Inc. · MNI · Feb 23, 2009 · Orthopedic

Device Facts

• Record ID: K083178
• Device Name: SOLAS ANATOMIX SPINAL SYSTEM
• Applicant: Biotechni America Spine Group, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Feb 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BASG, Inc., SOLAS AnatomixTM, Spinal System is a modular pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the SOLAS Anatomix™ is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). The SOLAS Anatomix™ is intended for anterior/anterolateral and posterior, non-cervical and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture and/or dislocation) spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Modular spinal fixation system; includes screws, housing assemblies, rods, connectors, cross-link mechanism, and specialized instruments. Used for anterior, anterolateral, and posterior spinal applications. Provides immobilization and stabilization of spinal segments as an adjunct to fusion. Implanted by surgeons in clinical settings. Components fabricated from Titanium alloy. System facilitates surgical correction of spinal deformities and stabilization of instabilities; benefits patient by promoting solid fusion and restoring spinal alignment.

Clinical Evidence

Bench testing only. Mechanical testing conducted via ASTM F1717-04 demonstrated equivalence to predicate devices.

Technological Characteristics

Modular spinal fixation system; components fabricated from Titanium alloy conforming to ASTM F 136. Mechanical performance validated per ASTM F1717-04. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion for severe spondylolisthesis (Grade 3-4) at L5-S1, or acute/chronic instabilities/deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, failed previous fusion, degenerative disc disease, and spinal stenosis.

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

• NV Cormed, SOLAS™ Spinal System (K051959)
• Micron Precision Engineering, AMT Spinal System (K002059)
• Stryker® Spine, XIA™ Spinal System (K001319)

Submission Summary (Full Text)

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KOD 3178

#### 5. 510(k) Summary

The following information is being submitted in conformance with 21 CFR 807.92(c):

Manufacturer: Biotechni America Spine Group, Inc. (BASG, Inc) 28R Cook Street Billerica. MA 01821 Tel.: [phone] Fax: [phone]

FEB 2 3 2009

David S. Randol, Director Contact:

October 3, 2008 Date Prepared:

SOLAS AnatomixTM Spinal System Trade Name:

Common Name: Pedicle Screw Spinal System

Classification: Spinal Intervertebral Body Fixation Orthosis (KWQ) (21 CFR § 888.3060) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3855) Spinal Pedicle Screw (MNI) (21 CFR § 888.3070) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3900) Spondylolisthesis Spinal Fixation Device System (MNH) (21 CFR § 888.3070) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3899)

Legally Marketed Predicate Devices for the Application:

NV Cormed, SOLAS™ Spinal System -MNH, KWQ, MNI - (K051959) Micron Precision Engineering, AMT Spinal System - KWP, MNH -- K002059) Stryker® Spine. XIA™ Spinal System -- MNH, MNI, KWQ -- (K001319)

### Device Description:

The SOLAS Anatomix Spinal System is a new modular spinal fixation system which can be used for anterior, antereolateral, posterior applications. This system includes screws, housing assemblies, rods, connectors and a cross-link mechanism in conjunction with specialized instruments which facilitate application. All implant components are fabricated from Titanium allov that conforms to ASTM F 136.

### Intended Use:

The BASG, Inc., SOLAS AnatomixTM, Spinal System is a modular pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the SOLAS Anatomix™ is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

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The SOLAS Anatomix™ is intended for anterior/anterolateral and posterior, non-cervical and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as hen' pain of discogenic origin with degeneration of the disc confirmed by history and padiographic studies), spondylolisthesis, trauma (i.e., fracture and/or dislocation) spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.

## Technological Characteristics - Comparison to Predicates:

The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use, and operational principles. The differences between the application device and the predicate devices do not change the indications, nor does the method of implantation.

## Performance Data - Comparison to Predicates:

Performance testing followed the instructions and recommendations in the CDRH document: "Guidance for Industry and FDA Staff: Spinal System 510(k), May 3, 2004 (www.fda.gov/cdrh/ode/guidance/636.pdf). Mechanical testing results conducted via ASTM F1717-04 demonstrated equivalence to the above listed predicate devices and is detailed in the body of the application. Table 5.1 on next page summarizes the required testing and comparisons.

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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 a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black and white, and the text is in all capital letters.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biotechni America Spine Group, Inc. % Kinetic Research & Design, Inc. Daniel R. Baker, Ph.D. 13203 39th Avenue, NE Seattle, Washington 98125

FEB 2 3 2009

Re: K083178

Trade/Device Name: BASG, Inc., SOLAS Anatomix™, Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWQ Dated: January 21, 2009 Received: January 27, 2009

Dear Dr. Baker:

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 (OS) 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 - Daniel R. Baker, Ph.D.

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 yours,

Mark A. Milken

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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## 4. INDICATIONS FOR USE

## 510(k) Number (if known): K083178.

Device Name: BASG, Inc., SOLAS Anatomix™, Spinal System

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In addition, the SOLAS Anatomix™ is intended to provide immobilization and stabilization of In addition, the SOLAO Anatomix - 16 miontoa san adjunct to fusion in the treatment of the Spinal Segments in Skeletally mature patientes of the thoracic, lumbar and sacral spine.
following acute and chronic instabilities or deformities of the thoracic, lumbar and following acute and chromo inclubinator of neurological imparment, fracture, degenerative spondylolisthosis with objective on failed previous fusion (pseudoarthrosis).

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Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 807 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milken

(Division Sign-Off) (Division of General, Restorative, and Neurologica

510(k) Number