(102 days)
The ZYFUSE™ Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from L1 to S1. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle.
The ZYFUSE™ Facet Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations.
The ZYFUSE™ Facet Fixation System consists of screws designed to compact juxtaposed facet articular processes to enhance spinal fusion. The cannulated, partially threaded screws are available with or without a washer, and in various diameters and lengths to accommodate patient anatomy. The ZYFUSE™ Facet Fixation System implants are fabricated from medical grade titanium alloy as specified in ASTM F136, F1295 and HA coated as specified in ASTM F1185. Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be used in the same construct as stainless steel implants.
The provided text is related to a 510(k) premarket notification for the ZYFUSE™ Facet Fixation System. It describes the device, its intended use, and its basis for substantial equivalence to legally marketed predicate devices.
However, the provided text does NOT contain information regarding:
- Acceptance criteria and reported device performance in a table.
- A study that proves the device meets specific acceptance criteria.
- Sample size for test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory submission for a medical device (a facet fixation system, which is an implantable mechanical device) and not for an AI algorithm or a diagnostic imaging device. Therefore, the types of studies and performance metrics typically associated with AI/software devices (like those you've listed) are not relevant or present in this context.
In summary, based on the provided text, it is not possible to answer the questions about acceptance criteria, study details, expert involvement, and ground truth establishment, as these concepts are not applicable to the type of device and submission described. The 510(k) submission for the ZYFUSE™ Facet Fixation System relies on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use as opposed to performance studies against specific acceptance criteria for AI-based outcomes.
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JUL 1 4 2009
510(k) SUMMARY: ZYFUSE™ Facet Fixation System
| Company: | Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403(610) 415-9000 |
|---|---|
| Contact: | Kelly J. Baker, Ph.DDirector, Clinical Affairs & Regulatory |
Device Name: ZYFUSE™ Facet Fixation System
Classification: Product Code MRW. Unclassified.
CORRIDOR Fixation System (K083442) Predicate(s):
Device Description:
The ZYFUSE™ Facet Fixation System consists of screws designed to compact juxtaposed facet articular processes to enhance spinal fusion. The cannulated, partially threaded screws are available with or without a washer, and in various diameters and lengths to accommodate patient anatomy. The ZYFUSE™ Facet Fixation System implants are fabricated from medical grade titanium alloy as specified in ASTM F136, F1295 and HA coated as specified in ASTM F1185. Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be used in the same construct as stainless steel implants.
Intended Use:
The ZYFUSE™ Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone araft, at single or multiple levels, from L1 to S1. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet ioint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle.
The ZYFUSE™ Facet Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis: degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations.
Basis for Substantial Equivalence:
The ZYFUSE™ Facet Fixation System is similar in terms of indications, design, materials, and performance, to currently marketed devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Globus Medical, Inc. % Kelly J. Baker, Ph.D. 2650 General Armistead Ave., Valley Forge Audubon, PA 19403
Re: K090952
Trade/Device Name: Zyfuse Facet Fixation System Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: MRW Dated: May 18, 2009 Received: May 19, 2009
Dear Dr. Baker:
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 I ou may, dierely interes of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JUL 1 4,2009
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 I read of acreate 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 device relation daverse or ends) (21 centation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Kelly J. Baker, Ph.D.
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Barbara Buehns
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
510(k) Number:
Ko90952
Device Name:
ZYFUSE™ Facet Fixation System
Indications:
The ZYFUSE™ Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. with or without bone graft, at single or multiple levels, from L1 to S1. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle.
The ZYFUSE™ Facet Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies: degeneration of the facets with instability and trauma including spinal fractures and/or dislocations.
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)
${\xi}$ (EXT for MKA)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090952
N/A