(140 days)
No
The description focuses on the mechanical components and materials of a spinal fixation system, with no mention of AI or ML capabilities.
Yes.
The device is used to hold bone allograft material in place in the spine, prevent allograft expulsion, or impinge the spinal cord, and stabilize a weakened or displaced lamina, which directly addresses a medical condition or ailment.
No
This device is a surgical fixation system (spinal fixation plates and screws) used in laminoplasty procedures to hold bone allograft material in place. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of spinal fixation plates and screws, which are physical hardware components. There is no mention of software being the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (laminoplasty) to fix bone allograft material in the spine. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device consists of physical implants (plates and screws) made of materials like titanium and polymer, designed to be surgically implanted. This is characteristic of a medical device used for structural support and fixation within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status through in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The CANOPY™ Laminoplasty Fixation System does not fit this description.
N/A
Intended Use / Indications 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 in place in order to prevent the allograft from expulsion or impinging the spinal cord.
Product codes
NQW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
RELIEVE® Laminoplasty Fixation System (K080664), Medtronic CENTERPIECE® Plate Fixation System (K050082), DePuy MOUNTAINEER® Laminoplasty System (K091994), Synthes ARCH Fixation System (K032534)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
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.(b)
Classification. Class II.
0
OCT 3 1 2012
510(k) Summary: CANOPY™ Laminoplasty Fixation System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Marie Fitzgerald
Project Manager, Regulatory Affairs |
| Date Prepared: | June 12, 2012 |
| Device Name: | CANOPY™ Laminoplasty Fixation System |
| Classification: | Per 21 CFR as follows:
§888.3050 Spinal Interlaminal Fixation Orthosis
Product Code NQW.
Regulatory Class II, Panel Code 87. |
| Predicate(s): | RELIEVE® Laminoplasty Fixation System (K080664)
Medtronic CENTERPIECE® Plate Fixation System (K050082)
DePuy MOUNTAINEER® Laminoplasty System (K091994)
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
1
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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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
3
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 (800) 638-2041 or (301) 796-7100 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_