PIONEER POSTERIOR CERVICO-THORACIC SYSTEM

K092295 · Pioneer Surgical Technology · KWP · Feb 19, 2010 · Orthopedic

Device Facts

• Record ID: K092295
• Device Name: PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
• Applicant: Pioneer Surgical Technology
• Product Code: KWP · Orthopedic
• Decision Date: Feb 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows: - Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - Spondylolisthesis - Spinal Stenosis - Fracture/ Dislocation - Deformities or Curvature - Tumors - Pseudoarthrosis - Revision of previous cervical and upper thoracic spine surgery The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

Device Story

Pioneer Posterior Cervico-Thoracic System is a spinal fixation construct consisting of rods, hooks, polyaxial screws, favored angle screws, locking caps, and connecting components. Used by surgeons in clinical settings to stabilize the cervico-thoracic spine (C1-T3) to promote fusion. Components are implanted to provide structural support following trauma, deformity correction, or degenerative disease treatment. System can integrate with Pioneer Quantum Spinal Rod System via parallel connectors. Device provides mechanical stabilization; clinical benefit is achieved through spinal fusion. No software or electronic components involved.

Clinical Evidence

Bench testing only. Performance data per recognized ASTM standards was presented to demonstrate mechanical integrity and substantial equivalence.

Technological Characteristics

Construct components manufactured from medical grade titanium alloy and cobalt chromium. Materials comply with ASTM standard specifications. System includes rods, hooks, polyaxial/favored angle screws, and locking caps. Mechanical fixation device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring spinal fusion in the cervico-thoracic region (C1-T3) due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, deformities/curvature, tumors, pseudoarthrosis, or revision of previous surgery. Screws are restricted to T1-T3 thoracic placement; not for cervical spine use.

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

• Atoll Cervico-Thoracic System (K070638)
• Summit OCT Spinal System (K002733)
• VERTEXTM Reconstruction System (K003780)
• Spine Oasys System (K032394)
• Cervifix/ Starlock System (K990965)

Submission Summary (Full Text)

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### Pioneer Posterior Cervico-Thoracic System

# 510(k) Summary

FEB 1 9 2010

| Sponsor: | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, MI 49855<br>[phone]<br>Contact: Emily M. Downs | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------|
| Device Name: | Pioneer Posterior Cervico-Thoracic System | | |
| Classification Name: | Spinal Interlaminal Fixation Orthosis<br>Pedicle Screw System | | |
| Classification Number: | Product Code/ Regulation Number:<br>KWP/ 888.3050 - Spinal Interlaminal Fixation Orthosis<br>MNI/ 888.3070(b)(1)- Pedicle Screw Spinal System<br>MNH/ 888.3070(b)(1)- Pedicle Screw Spinal System<br>Panel Code: 87 | | |
| Description: | The Pioneer Posterior Cervico-Thoracic System consists of a variety of<br>rods, hooks, polyaxial screws, favored angle screws, locking caps, and<br>connecting components used to build a cervico-thoracic spinal<br>construct. | | |
| | The Pioneer Posterior Cervico-Thoracic System components are<br>manufactured from medical grade titanium alloy and medical grade<br>cobalt chromium. Medical grade titanium alloy and medical grade<br>cobalt chromium may be used together. | | |
| | The Pioneer Posterior Cervico-Thoracic System can be attached to<br>Pioneer Quantum® Spinal Rod System using parallel connectors. | | |
| | The system also contains Class 1 manual surgical instruments and cases<br>that are considered exempt from premarket notification. | | |
| Intended Use: | The Pioneer Posterior Cervico-Thoracic System is indicated to promote<br>fusion of the cervico- thoracic regions of the spine (C1-T3). The<br>intended indications are as follows: | | |
| | - Degenerative Disc Disease (as defined by neck or back pain of<br>discogenic origin with degeneration of the disc confirmed by history<br>and radiographic studies | | |
| | - Spondylolisthesis | | |
| Pioneer Surgical Technology | | 119 | February 12, 2010 |

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| K0922 95 | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pioneer Posterior Cervico-Thoracic System | |
| | - Spinal Stenosis |
| | - Fracture/ Dislocation |
| | - Deformities or Curvature |
| | - Tumors |
| | - Pseudoarthrosis |
| | - Revision of previous cervical and upper thoracic spine surgery |
| | The use of the screws is limited to placement in the upper thoracic spine<br>(T1-T3) in treating thoracic conditions only. The screws are not<br>intended for use in the cervical spine. |
| | The hooks and rods are also intended to provide stabilization to promote<br>fusion following reduction of fracture/ dislocation or trauma in the<br>cervical/ upper thoracic (C1-T3) spine. |
| Material: | Materials used to manufacture the implants and instruments of this<br>system follow ASTM Standard Specifications. |
| Performance Data: | Testing per recognized ASTM standards was presented. |
| Performance and SE<br>Determination: | The characteristics of the Pioneer Posterior Cervico-Thoracic System<br>are similar to the following predicate devices: |
| | 1. Atoll Cervico-Thoracic System (K070638), Theken Spine, SE date<br>05/30/2007. |
| | 2. Summit OCT Spinal System (K002733), DePuy AcroMed, Inc., SE<br>date 12/15/2000. |
| | 3. VERTEXTM Reconstruction System (K003780), Medtronic Sofamor<br>Danek USA, Inc., SE date 09/28/2001. |
| | 4. Spine Oasys System (K032394), Stryker, SE date 2/20/2004 |
| | 5. Cervifix/ Starlock System (K990965) Synthes (USA), SE date<br>7/1/1999. |
| | Equivalence for Pioneer Posterior Cervico-Thoracic System is based on<br>similarities of intended use, design, and physical characteristics when<br>compared to predicate devices. Therefore, Pioneer Surgical Technology<br>believes that there is sufficient evidence to conclude that the Pioneer<br>Posterior Cervico-Thoracic System is substantially equivalent to<br>existing legally marketed devices. |
| | |

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February 12, 2010

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains the department's emblem, which is a stylized representation of a human figure.

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

## FEB 1 9 2010

Pioneer Surgical Technology, Inc. % Ms. Emily M. Downs 375 River Park Circle Marquette, Michigan 49855

Re: K092295

Trade/Device Name: Pioneer Posterior Cervico-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: February 12, 2010 Received: February 16, 2010

Dear Ms. Downs:

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 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

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Page 2 - Ms. Emily M. Downs

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/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. Millman

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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#### Pioneer Posterior Cervico-Thoracic System

#### 3.0 Indications for Use Statement

K09 2295 510(k) Number (if knówn):

Pioneer Posterior Cervico-Thoracic System Device Name:

Indications:

The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows:

- Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis -
- Spinal Stenosis -
- -Fracture/ Dislocation
- -Deformities or Curvature
- -Tumors
- Pseudoarthrosis -
- Revision of previous cervical and upper thoracic spine surgery -

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

> Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Pioneer Surgical Technology Premarket Notification | 510(k) Number: K092295 | Confidential July 27, 2009 |
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