PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM

K072703 · Pioneer Surgical Technology · KWQ · Jan 10, 2008 · Orthopedic

Device Facts

• Record ID: K072703
• Device Name: PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
• Applicant: Pioneer Surgical Technology
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer SlimFuse Anterior Cervical Plating System 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

System consists of titanium alloy (Ti 6Al 4V ELI) plates and screws used for anterior cervical fixation; provides stabilization as adjunct to cervical fusion. Implanted by surgeons in clinical/OR settings. Device functions as mechanical fixation hardware to stabilize spinal segments during fusion process. Benefits include structural support for spinal column in patients with degenerative, traumatic, or deformity-related conditions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Constructed from Ti 6Al 4V ELI titanium alloy conforming to ASTM standards. System comprises plates and screws for spinal intervertebral body fixation. Mechanical device; no software or energy source.

Indications for Use

Indicated for anterior cervical fixation as an adjunct to cervical fusion in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, 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

• K040366
• K053053
• K042544

Submission Summary (Full Text)

{0}------------------------------------------------

K072703

# Pioneer SlimFuse Anterior Cervical Plating System

#### 3.0 510(k) Summary

| Sponsor: | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, MI 49855<br>[phone]<br>Contact: Jonathan M. Gilbert | JAN 10 2008 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name: | Pioneer SlimFuse Anterior Cervical Plating System | |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, Class II. | |
| Classification Number: | Regulation Number: 888.3060<br>Product Code: KWQ<br>Panel Code: 87 | |
| Predicate Devices: | K040366<br>K053053<br>K042544 | |
| Description: | The Pioneer SlimFuse Anterior Cervical Plating System<br>consists of an assortment of plates and screws. The<br>system also contains Class 1 manual surgical instruments<br>and cases that are considered exempt from premarket<br>notification. | |
| Intended Use: | The Pioneer SlimFuse Anterior Cervical Plating System<br>intended for anterior cervical fixation for the following<br>indications: degenerative disc disease (DDD) (defined as<br>neck pain of discogenic origin with degeneration of the<br>disc confirmed by history and radiographic studies),<br>spondylolisthesis, trauma (i.e., fracture or dislocation),<br>spinal stenosis, deformities or curvatures (i.e., scoliosis,<br>kyphosis, and/or lordosis), tumor, pseudoarthrosis, and<br>failed previous fusion. | |
| Material: | Materials (Ti 6A1 4V ELI) used to manufacture the<br>implants and instruments of this system are in<br>conformance with ASTM Standard Specifications. | |
| Performance Data: | Testing per recognized ASTM standards was presented. | |
| Performance and SE<br>Determination: | Comparisons of device performance data, materials,<br>indications and design/function to predicate devices were<br>provided in making a determination of substantial<br>equivalence. | |

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three overlapping wing segments, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JAN 10 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pioneer Surgical Technology % Mr. Jonathan M. Gilbert 375 River Park Circle Marquette, MI 49855

Re: K072703

Trade/Device Name: Pioneer SlimFuse Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 14, 2007 Received: December 17, 2007

Dear Mr. Gilbert:

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.

{2}------------------------------------------------

## Page 2 – Mr. Jonathan M. Gilbert

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 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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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

Enclosure

{3}------------------------------------------------

Page 1 of 1

#### 2.0 Indications for Use Statement

K072703 510(k) Number (if known):

Device Name:

Pioneer SlimFuse Anterior Cervical Plating System

Indications:

The Pioneer SlimFuse Anterior Cervical Plating System is intended for anterior cervical fixation as an adjunct to cervical fusion 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 (Per 21 CFR 801.109)

Over-the

Over-the-Counter Use

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbave Pouellm
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K02703