CANOPY LAMINOPLASTY FIXATION SYSTEM

K121732 · Globus Medical, Inc. · NQW · Oct 31, 2012 · Orthopedic

Device Facts

• Record ID: K121732
• Device Name: CANOPY LAMINOPLASTY FIXATION SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: NQW · Orthopedic
• Decision Date: Oct 31, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CANOPY™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY™ Laminoplasty Fixation System is used to hold bone allograft material in place in order to prevent the allograft from expulsion or impinging the spinal cord.

Device Story

CANOPY™ Laminoplasty Fixation System consists of spinal fixation plates and screws used in posterior cervical or thoracic laminoplasty. Implants are available in various sizes/geometries to accommodate patient anatomy. Plates secure bone allograft material to prevent expulsion or spinal cord impingement; hinge plates stabilize weakened or displaced lamina. System is used by surgeons in clinical settings. Implants are manufactured from titanium/titanium alloy; optional radiolucent polymer graft chambers include tantalum or titanium markers for radiographic visualization. Device provides mechanical stabilization of the spine during surgical reconstruction.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic compression, static compression bending, and expulsion testing in accordance with ASTM F543 and F2193 and relevant FDA guidance for spinal systems.

Technological Characteristics

Materials: Titanium/titanium alloy (ASTM F67, F136, F1295, F1472); radiolucent polymer (ASTM F2026) with tantalum/titanium markers. Components: Spinal fixation plates, screws, and optional graft chambers. Form factor: Various sizes/geometries for C3-T3 spine. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing laminoplasty procedures in the lower cervical and upper thoracic spine (C3-T3) to secure bone allograft material and prevent expulsion or spinal cord impingement.

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

• RELIEVE® Laminoplasty Fixation System (K080664)
• Medtronic CENTERPIECE® Plate Fixation System (K050082)
• DePuy MOUNTAINEER® Laminoplasty System (K091994)
• Synthes ARCH Fixation System (K032534)

Submission Summary (Full Text)

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OCT 3 1 2012

# 510(k) Summary: CANOPY™ Laminoplasty Fixation System

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Marie Fitzgerald<br>Project Manager, Regulatory Affairs |
| Date Prepared: | June 12, 2012 |
| Device Name: | CANOPY™ Laminoplasty Fixation System |
| Classification: | Per 21 CFR as follows:<br>§888.3050 Spinal Interlaminal Fixation Orthosis<br>Product Code NQW.<br>Regulatory Class II, Panel Code 87. |
| Predicate(s): | RELIEVE® Laminoplasty Fixation System (K080664)<br>Medtronic CENTERPIECE® Plate Fixation System (K050082)<br>DePuy MOUNTAINEER® Laminoplasty System (K091994)<br>Synthes ARCH Fixation System (K032534) |

#### Purpose:

The purpose of this submission is to request clearance for the CANOPY™ Laminoplasty Fixation System.

#### Device Description:

The CANOPY™ Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY™ implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

CANOPY™ plates and screws are manufactured from titanium or titanium allov. as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent polymer as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.

#### Indication for Use:

The CANOPY™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY™ Laminoplasty Fixation System is used to hold bone allograft material

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in place in order to prevent the allograft from expulsion or impinging the spinal cord.

### Performance Data:

Mechanical testing (static and dynamic compression, static compression bending and expulsion) was conducted in accordance with ASTM F543 and F2193 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.

### Basis of Substantial Equivalence:

The CANOPY™ Laminoplasty Fixation System implants are similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.

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

OCT 31 2012

Globus Medical, Incorporated % Ms. Sarah Marie Fitzgerald Project Manager, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K121732

Trade/Device Name: CANOPY™ Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: September 28, 2012 Received: October 01, 2012

Dear Ms. Fitzgerald:

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. Sarah Marie Fitzgerald

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,

Sincerely yours,

Mark N. Melkerson
Director

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

510(k) Number:

CANOPY™ Laminoplasty Fixation System Device Name:

#### INDICATIONS:

The CANOPY™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY™ Laminoplasty Fixation System is used to hold bone allograft material in place in order to prevent the allograft from expulsion or impinging the spinal cord.

Prescription Use × (Per 21 CFR §801.109) 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)

(Division Sign-Off) Diy/sion of Surgical, Orthopedic, and Restorative Devices

KIZI732 510(k) Number_