APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER

K092825 · Spinecraft, Inc. · KWP · Mar 16, 2010 · Orthopedic

Device Facts

• Record ID: K092825
• Device Name: APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
• Applicant: Spinecraft, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Mar 16, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers 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; spinal tumor; and failed previous fusion (pseudoarthrosis). The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers 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 (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers is also a hook and sacral/liac 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 5.5mm Rod and Polyaxial Screw Washers when used with pedicle screws are indicated for degenerative 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

Rod-based spinal fixation system; includes 5.50mm titanium rods and polyaxial screw washers. Designed to interface with previously cleared APEX system components (monoaxial/polyaxial screws, hooks, connectors). Washers available in two sizes to accommodate screw shaft diameters ranging from 4.75mm to 8.50mm. Used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments during fusion procedures. Mechanical performance verified via bench testing to ensure comparability to predicate systems. Benefits patients by stabilizing spinal segments to facilitate fusion in cases of deformity, trauma, or degenerative disease.

Clinical Evidence

Bench testing only. Mechanical and dynamic testing performed to compare performance against predicate devices; results demonstrate comparable or superior mechanical performance.

Technological Characteristics

Implant grade titanium alloy (Ti-6Al-4V) per ASTM F-136 and ISO 5832-3. Rod-based system with polyaxial screw washers. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats thoracic, lumbar, and sacral spine conditions: severe spondylolisthesis (Grades 3-4, L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, and pseudoarthrosis. Used with autogenous bone graft for pedicle screw fixation (L3-sacrum).

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

• APEX Spine System (K062513)
• MONARCH Spine System (K010576, K024348)
• MOSS MIAMI Spinal System (K013296)

Submission Summary (Full Text)

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SpineCraft

510(k) Premarket Notification APEX Spine System 5.5mm Rod & Polyaxial Screw Washer

K092825

## 510(k) SUMMARY

# MAR 1 6 2010

| SUBMMITTER: | SpineCraft, LLC<br>2215 Enterprise Drive<br>Westchester, IL 60154-5819 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT<br>REGISTRATION No: | 3004717358 |
| CONTACT PERSON: | Ami Akallal-Asaad, Director of Regulatory Affairs |
| DATE PREPARED: | September 8, 2009 |
| CLASSIFICATION NAME: | Spinal Interlaminal Fixation Orthosis - 888.3050<br>Spinal Pedicle Fixation - 888.3070(b) (1) |
| PROPRIETARY NAME: | APEX Spine System 5.50mm Titanium Rod and Polyaxial<br>Screw Washers |
| COMMON NAME: | Spinal Fixation System |
| PRODUCT CODE: | KWP, MNH, MNI |
| CLASSIFICATION PANEL: | 87 |
| PRODUCT DESCRIPTION: | The APEX Spine System 5.50mm Titanium Rod and Polyaxial<br>Screw Washers is a rod-based system designed to interface with<br>various spinal anatomies. The 5.50mm Rods are available in<br>various lengths and are designed for use with the previously<br>cleared titanium alloy components of the APEX Spine System<br>which can accept a 5.50mm spinal rod, including monoaxial,<br>polyaxial screws, hooks, and connectors. The polyaxial screw<br>washers are available in 2 sizes. The smaller washer size is for<br>use with the APEX Polyaxial Screws with shaft diameter from<br>4.75mm to 7.00mm and the larger washer size to be used with<br>the APEX Polyaxial Screws with shaft diameters 7.75mm and<br>8.50mm. |
| MATERIALS: | The APEX Spine System 5.50mm Titanium Rod and Polyaxial<br>Screw Washers is manufactured from implant grade titanium<br>Alloy (Ti-6Al-4V) conforming to ASTM standard F-136 and ISO<br>5832-3. |
| INDICATIONS FOR USE: | The APEX Spine System 5.50mm Titanium Rod and Polyaxial<br>Screw Washers is intended to provide immobilization and<br>stabilization of spinal segments in skeletally mature patients as<br>an adjunct to fusion in the treatment of the following acute and<br>chronic instabilities or deformities of the thoracic, lumbar, and<br>sacral spine: severe spondylolisthesis (grades 3 and 4) of the<br>L5-S1 vertebra; degenerative spondylolisthesis with objective |

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evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers 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 (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers 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 confirmed by by history and radiographic disc 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 5.50mm Titanium Rod and Polyaxial Screw Washers 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 following predicate devices:

- I APEX Spine System: K062513 - SpineCraft
- 트 MONARCH Spine System: K010576, K024348 - DePuy AcroMed, Inc.
- . MOSS MIAMI Spinal System: K013296 - DePuy AcroMed, Inc.

The substantial equivalence of the APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers 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 svstems.

Mechanical and dynamic testing of the APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers was performed. The test results demonstrate that the mechanical performance of the APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers is at least comparable to, if not better than, those of the predicate devices.

#### SUBSTANTIAL EQUIVALENCE:

PERFORMANCE DATA:

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping wing-like shapes.

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

SpineCraft, LLC % Ami Akallal-Asaad Director of Regulatory Affairs 2215 Enterprise Drive Westchester, Illinois 60154-5819

# MAR 1 5 2010

Re: K092825

Trade/Device Name: APEX Spine System 5.50mm Titanium Rod and Polyaxial Screw Washers Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: February 17, 2010

Received: February 18, 2010

Dear Ami 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. 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

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## Page 2 - Ami Akallal-Asaad

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.

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/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.

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

Sincerely vours.

Barbara Brimm.

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

Enclosure

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## Indication for Use Statement

510(k) Number (if known): ______KO92825

### Device Name: APEX Spine System 5.5mm Rod and Polyaxial Screw Washers

### Indication for Use:

The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers 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; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers 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 (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers is also a hook and sacral/liac 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 5.5mm Rod and Polyaxial Screw Washers when used with pedicle screws are indicated for degenerative 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)

signature

(Division Sigh-Off) (Division Sign of Surgical, Orthopedic, And Restorative Devices

K092825 510(k) Number_