(231 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural stability of the implants, with no mention of AI or ML capabilities.
Yes
The device is described as an anterior cervical fusion device intended for conditions such as degenerative disc disease, trauma, tumors, and deformity, which are medical conditions that require treatment. It is used with bone graft material and aims to provide structural stability, indicating a therapeutic purpose.
No
The device description indicates that the COALITION AGX™ Plate and Spacer are devices used for anterior screw fixation and interbody fusion in the cervical spine to treat various conditions, rather than for identifying or detecting diseases.
No
The device description explicitly states that the device is made from titanium alloy and PEEK polymer, which are hardware materials. The performance studies also describe mechanical testing of physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The COALITION AGX™ Plate and Spacer are surgical implants intended for anterior screw fixation and interbody fusion in the cervical spine. They are physical devices used within the body to provide structural support and facilitate bone fusion.
- Lack of Diagnostic Activity: The description and intended use do not mention any testing of biological samples or diagnostic purposes. The device's function is purely therapeutic and structural.
Therefore, the COALITION AGX™ Plate and Spacer fall under the category of medical devices, specifically surgical implants, rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The COALITION AGX™ Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-TI) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The COALITION AGX™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGXTM Plate acting as the supplemental fixation.
Product codes
ODP, OVE, KWQ
Device Description
The COALITION AGX™ Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136, F1295, and F1472. The screws for use with the COALITION AGX™ Plates are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
COALITION AGX™ Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The COALITION AGX™ Spacers are manufactured from radiolucent PEEK polymer. with titanium alloy or tantalum markers, as specified in ASTM. F2026, F136. F1295, F1472, and F560.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C7), cervical spine (C2-T1)
Indicated Patient Age Range
Skeletally mature patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing for the COALITION AGX™ Plate (static and dynamic compression bend, and static torsion), for the COALITION AGX™ Spacer (static and dynamic compression, static and dynamic compression-shear, static and dynamic torsion, and subsidence), and for the COALITION AGX™ Plate and Spacer (static compression, compression-shear, torsion, expulsion, subsidence, and plate pull-off) was conducted in accordance with the Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s (May 3, 2004) and ASTM F1717, F2077 and F2267, as applicable. Design validation/cadaver testing was conducted to ensure the COALITION AGX™ System performance is acceptable for its intended use and to ensure substantial equivalence to the predicate(s). Biomechanical cadaveric testing was also conducted. Performance and comparative analysis data demonstrate substantial equivalence to the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K130478, K081391, K092070, K122630, K073285, K072991, K083389
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting a sense of community and support. The profiles are positioned within a circular frame, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" encircling the figure. The text is written in a simple, sans-serif font, and the overall design is clean and professional.
April 9, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Globus Medical, Incorporated Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K142218
Trade/Device Name: COALITION AGX™ Plate and COALITION AGX™ Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE, KWQ Dated: March 31, 2015 Received: March 31, 2015
Dear Dr. Baker:
This letter corrects our substantially equivalent letter of March 31, 2015.
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
1
Page 2 - Kelly J. Baker, Ph. D.
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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142218
Device Name
COALITION AGX™ Plate and COALITION AGX™ Spacer
Indications for Use (Describe)
The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The COALITION AGX™ Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-TI) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The COALITION AGX™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGXTM Plate acting as the supplemental fixation.
Type of Use (Select one or both, as applicable)
| 区 Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
==============================================================================================================================================================================
3
510(k) SUMMARY: COALITION AGX™ System
| Company: | Globus Medical Inc.
2560 General Armistead Avenue
Audubon, PA 19403
(610) 930-1800 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly Baker, Ph.D.
Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | March 23, 2015 |
| Device Name: | COALITION AGXTM Plate and COALITION AGXTM Spacer |
| Classification: | 21CFR §888.3080 Intervertebral Body Fusion Devices
21CFR §888.3080 Intervertebral Fusion Device with
Integrated Fixation, Cervical
Product Codes: ODP, OVE
Regulatory Class: II; Panel Code: 87
21CFR §888.3060 Spinal Intervertebral Body Fixation
Orthosis
Product Code: KWQ
Regulatory Class: II; Panel Code: 87 |
| Primary Predicate: | SUSTAIN® Radiolucent Medium (K130478) |
| Additional
Predicates: | VIP® Anterior Cervical Plate System (K081391)
InterPlateTM C (K092070)
IN:C2TM Spinal Fixation System (K122630)
PEEK Prevail® Cervical Interbody Device (K073285)
PATRIOT® Colonial® ACDF Spacer (K072991)
COALITION® Spacer (K083389) |
Purpose:
The purpose of this submission is to request clearance for the COALITION AGX™ Plate and COALITION AGX™ Spacer.
Device Description:
The COALITION AGX™ Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136, F1295, and F1472. The screws for use with the COALITION AGX™ Plates are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
4
COALITION AGX™ Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The COALITION AGX™ Spacers are manufactured from radiolucent PEEK polymer. with titanium alloy or tantalum markers, as specified in ASTM. F2026, F136. F1295, F1472, and F560.
Indications for Use:
The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). trauma (including fractures). tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The COALITION AGX™ Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The COALITION AGX™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation.
Performance Data:
Mechanical testing for the COALITION AGX™ Plate (static and dynamic compression bend, and static torsion), for the COALITION AGX™ Spacer (static and dynamic compression, static and dynamic compression-shear, static and dynamic torsion, and subsidence), and for the COALITION AGX™ Plate and Spacer (static compression, compression-shear, torsion, expulsion, subsidence, and plate pull-off) was conducted in accordance with the Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s (May 3, 2004) and ASTM F1717, F2077 and F2267, as applicable. Design validation/cadaver testing was conducted to ensure the COALITION AGX™ System performance is acceptable for its intended use and to ensure substantial equivalence to the predicate(s). Biomechanical cadaveric testing was also conducted. Performance and comparative analysis data demonstrate substantial equivalence to the predicate device(s).
5
K142218 Page 3 of 3
Basis for Substantial Equivalence:
COALITION AGX™ implants are similar to the predicate devices with respect to technical characteristics, performance, design, materials, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. COALITION AGX™ implants are as safe, as effective, and perform as well as or better than predicate devices.