PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES

K111528 · Pioneer Surgical Technology, Inc. · KWQ · Aug 24, 2011 · Orthopedic

Device Facts

• Record ID: K111528
• Device Name: PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 24, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Pioneer Aspect Anterior Cervical Plate System provides anterior cervical fixation; consists of static plates (10-84mm) and screws (10-20mm length; 4.0/4.5mm diameter). Screws available in fixed/variable, self-tapping, and self-drilling configurations. Plates feature integrated Nitinol spring screw-retention mechanism. Used by surgeons in clinical settings to stabilize vertebral bodies. Device provides mechanical support to facilitate spinal fusion; benefits patients by addressing instability caused by trauma, degeneration, or deformity. Output is physical stabilization of the cervical spine.

Clinical Evidence

Bench testing only. Mechanical performance characterized via static and fatigue compression bending and static torsion (ASTM F1717), axial pullout screw strength (ASTM F543), and internal protocols for screw retention.

Technological Characteristics

Plates/screws: Titanium alloy (Ti6Al4V ELI, ASTM F136). Screw-retention mechanism: Nitinol (ASTM F2063). Static plate design (10-84mm). Screws (10-20mm length, 4.0/4.5mm diameter). Mechanical fixation via screw-plate construct.

Indications for Use

Indicated for patients requiring anterior cervical fixation due to degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Pioneer Poise Anterior Cervical Plate System (K100708)

Submission Summary (Full Text)

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K111528 Page 1 of \$

| 3.0 | 510(k) Summary | |
|-----|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sponsor: | Pioneer Surgical Technology<br>AUG 2 4 2011<br>375 River Park Circle<br>Marquette, MI 49855<br>[phone]<br>Contact: Sarah McIntyre<br>Date submitted: June 1, 2011 |
| | Device Name: | Pioneer Aspect Anterior Cervical Plate |
| | Classification Name: | The classification of the Pioneer Aspect Anterior Cervical Plate System is Class II, as<br>per the Code of Federal Regulations, Title 21, Section 888.3060: Spinal<br>intervertebral body fixation orthosis. |
| | Product Codes: | The product code is KWQ. The Panel code is 87. |
| | Predicate Device: | K100708 - Pioneer Poise Anterior Cervical Plate System (SE date 06/04/10) |
| | Description: | The Pioneer Aspect Anterior Cervical Plate System consists of an assortment of<br>plates and screws. The screws are used to secure the plates to the vertebral bodies of<br>the cervical spine through an anterior approach. The system consists of static plates<br>in lengths that range from 10-84mm and include one, two, three and four level<br>designs. The plates have an integrated screw retention mechanism. Screws range<br>from 10-20mm in length, 4.0 or 4.5mm in diameter, and are available in<br>fixed/variable self-tapping and self-drilling. |
| | Intended Use: | The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical<br>fixation for the following indications: degenerative disc disease (DDD) (defined as<br>neck pain of discogenic origin with degeneration of the disc confirmed by history and<br>radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal<br>stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor,<br>pseudoarthrosis, and failed previous fusion. |
| | Comparison to Predicate<br>Devices: | The subject device has indications for use identical to those of the predicate Pioneer<br>Poise system and employs the same principles of operation. Identical materials are<br>used for both subject and predicate plates and screws. Available screw lengths (10-<br>20mm), screw diameters (4.0, 4.5mm), overall plate length (10-84mm), and plate<br>types (one, two, three and four level; static) are identical to predicate. |
| | Material: | The Pioneer Aspect Anterior Cervical Plate System plates and screws are<br>manufactured from titanium alloy (Ti6Al4V ELI, according to ASTM F136). The<br>plates incorporate a screw-retention mechanism ("spring"), which is manufactured<br>from Nitinol (ASTM F2063). |
| | Non-Clinical<br>Performance Data: | Mechanical testing was presented to characterize construct and component<br>performance, including static and fatigue compression bending and static torsion<br>testing per recognized ASTM F1717, axial pullout screw strength per ASTM F543,<br>and additional testing performed per internal protocols to assess screw pull through /<br>retention characteristics. The test results of verification testing demonstrate that the<br>mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is<br>substantially equivalent to the predicate device. |
| | Performance and SE<br>Determination: | Comparisons of device performance data, materials, indications and design/function<br>to predicate devices were provided in making a determination of substantial<br>equivalence. |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pioneer Surgical Technology % Ms. Sarah McIntyre 375 River Park Circle Marquette, Michigan 49855

AUG 24 2011

Re: K111528

Trade/Device Name: Pioneer Aspect Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 22, 2011 Received: July 25, 2011

Dear Ms. McIntyre:

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

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Page 2 - Ms. Sarah McIntyre

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Wilkerson

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

Enclosure

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## Indications for Use Statement 2.0

| 510(k) Number (if known): | K111528 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Pioneer Aspect Anterior Cervical Plate |
| Indications for Use: | The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. |
| Prescription Use<br>(Per 21 CFR 801.109) | <div> <div style="float:left;">√</div> <div style="float:right;">OR</div> </div> |
| | Over-the-Counter Use _______ |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)_

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111528