APEX SPINE SYSTEM

K062513 · Spinecraft, Inc. · KWP · Dec 22, 2006 · Orthopedic

Device Facts

• Record ID: K062513
• Device Name: APEX SPINE SYSTEM
• Applicant: Spinecraft, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The APEX Spine System intended to provide immobilization 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; spinal tumor; and failed previous fusion (pseudoarthrosis). The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 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 (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion. The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scollosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis). The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

Device Story

APEX Spine System is a rod-based spinal fixation system; components include spinal rods, monoaxial screws, polyaxial screws, bolt-type pedicle screws, lateral connectors, and cross (transverse) connectors. Used by surgeons in the OR to provide immobilization and stabilization of spinal segments as an adjunct to fusion. System interfaces with spinal anatomy to treat instabilities or deformities. Mechanical performance supports clinical decision-making for spinal stabilization. Benefits include structural support for fusion in acute/chronic spinal conditions.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including mechanical and dynamic testing, demonstrating that the APEX Spine System's mechanical performance is at least comparable to the predicate devices.

Technological Characteristics

Rod-based spinal fixation system. Materials: Titanium Alloy (Ti-6Al-4V) conforming to ASTM F-136 and ISO 5832-3. Components: rods, monoaxial/polyaxial/bolt-type pedicle screws, lateral/cross connectors. Non-cervical spine application.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions: severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, and pseudoarthrosis. Used in thoracic, lumbar, and sacral spine.

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

• MONARCH Spine System (K010576, K024348)
• MOSS MIAMI Spinal System (K965145)
• OPTIMA Spinal System (K051971)
• Global Spinal Fixation System (K001668)

Submission Summary (Full Text)

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# 510(k) SUMMARY

| SUBMMITTER: | SpineCraft<br>2215 Enterprise Drive<br>Westchester, IL 60154-5819 | DEC 2 2 2006 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Ami Akallal-Asaad, Regulatory Affairs Manager | |
| DATE PREPARED: | November 02, 2006 | |
| CLASSIFICATION NAME: | Spinal Interlaminal Fixation Orthosis - 888.3050<br>Spinal Pedicle Fixation - 888.3070(b)(1) | |
| PROPRIETARY NAME: | APEX Spine System | |
| COMMON NAME: | Spinal Fixation System | |
| PRODUCT CODE: | KWP, MNH, MNI | |
| CLASSIFICATION PANEL: | 87 | |
| PRODUCT DESCRIPTION: | The APEX Spine System is a rod-based system designed to<br>interface with various spinal anatomies. The system consists<br>of spinal rods, monoaxial screws, polyaxial screws, bolt-type<br>pedicle screws, various lateral connectors, and various cross<br>(transverse) connectors. | |
| MATERIALS: | The APEX Spine System is manufactured from implant grade<br>titanium Alloy (Ti-6Al-4V) conforming to ASTM standard F-136<br>and ISO 5832-3. | |
| INDICATIONS FOR USE: | The APEX Spine System intended to provide immobilization<br>and stabilization of spinal segments in skeletally mature<br>patients as an adjunct to fusion in the treatment of the<br>following acute and chronic instabilities or deformities of the<br>thoracic, lumbar, and sacral spine: severe spondylolisthesis<br>(grades 3 and 4) of the L5-S1 vertebra; degenerative<br>spondylolisthesis with objective evidence of neurologic<br>impairment; fracture; dislocation; scoliosis; kyphosis; spinal<br>tumor; and failed previous fusion (pseudoarthrosis).<br>The APEX Spine System is also indicated for pedicle screw<br>fixation for the treatment of severe spondylolisthesis (Grades<br>3 and 4) of the L5-S1 vertebra in skeletally mature patients<br>receiving fusion by autogenous bone graft having implants<br>attached to the lumbar and sacral spine (L3 to sacrum) with<br>removal of the implants after the attainment of a solid fusion. | |

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and and and a man a control and consideration and model and and comments of the mail foundeline

The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis). tumor, and previous failed fusion (pseudo-arthrosis).

The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

#### The APEX Spine System is substantially equivalent to the SUBSTANTIAL EQUIVALENCE: following predicate devices:

- 트 MONARCH Spine System: K010576, K024348 -DePuy AcroMed.
- .. MOSS MIAMI Spinal System: K965145 - DePuy, Inc.
- I OPTIMA Spinal System: K051971 - U&I Corp.
- 트 Global Spinal Fixation System: K001668 - D.K.M. Co., Ltd.

The substantial equivalence of the APEX spine system to the above mentioned predicate devices is based upon equivalence in design, material, manufacturing standards, intended use, as well as indications and contraindications. The fundamental scientific technology of this system is identical to previously cleared systems.

PERFORMANCE DATA: Mechanical and dynamic testing of the APEX Spine System was performed. The test results demonstrate that the mechanical performance of the APEX Spine System is at least comparable to, if not better than, those of the predicate devices.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SpineCraft, Inc. % Ms. Ami Akallal-Asaad Regulatory Affairs Manager 2215 Enterprise Drive Suite 1504 Westchester, Illinois 60154

DEC 2 2 2006

Re: K062513

Trade/Device Name: APEX Spine System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, KWQ, MNI, MNH Dated: November 2, 2006 Received: November 6, 2006

Dear Ms. Akallal-Asaad:

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. Ami Akallal-Asaad

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

Opaubere Buchund

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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# A. Indication for Use Statement

### 510(k) Number (if known): K062513

#### Device Name: APEX Spine System

#### Indication for Use:

The APEX Spine System intended to provide immobilization 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; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 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 (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scollosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Paulin

estorative. and Neurological Devices

510(k) Number K062513