(99 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat diseased or damaged vertebral bodies by replacing them, restoring spinal integrity, and decompressing the spinal cord, which are all therapeutic actions.
No
This device is a vertebral body replacement device intended for surgical implantation to provide structural support, not to diagnose medical conditions.
No
The device description clearly states that COLOSSEUM™ Mesh devices are physical implants manufactured from titanium alloy, intended for surgical implantation as vertebral body replacements. This is a hardware device, not software.
Based on the provided information, the COLOSSEUM™ Mesh device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- COLOSSEUM™ Mesh Function: The COLOSSEUM™ Mesh is a surgical implant designed to replace diseased or damaged vertebral bodies in the spine. It is a physical device implanted into the body to provide structural support and aid in fusion.
- Lack of Diagnostic Activity: The device itself does not perform any diagnostic tests on biological samples. Its function is purely structural and supportive within the body.
Therefore, the COLOSSEUM™ Mesh falls under the category of a medical device, specifically a surgical implant, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a vertebral body replacement device in the cervical spine (C2-T1), COLOSSEUM™M Mesh devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used as a vertebral body replacement device in the thoracolumbar spine (T1-L5), COLOSSEUM™ Mesh devices are intended for use to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the vertebral body replacement device spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
Product codes
MQP, PLR
Device Description
COLOSSEUM™ Mesh are devices that can be used as vertebral body replacement devices. The components of the implant include a preformed mesh cage and optional endcaps, which are available in a range of sizes and options to accommodate various surgical approaches and the anatomical needs of a wide variety of patients. The mesh and the endcaps are intraoperatively assembled to best fit individual requirements. Protrusions (teeth) on the superior and inferior surfaces of the endcaps grip the endplate of the adjacent vertebrae to resist expulsion.
COLOSSEUM™ Mesh implants are used to provide structural stability and as an adjunct to fusion in skeletally mature individuals following corpectomy or vertebrectomy in the cervical and thoracolumbar spine. Thoracolumbar mesh implants may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral approach. Cervical mesh implants are inserted using an anterior approach.
COLOSSEUM™ Mesh implants are manufactured from titanium alloy as specified in ASTM F136. All implants are single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), Thoracolumbar spine (T1-L5)
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 (static and dynamic compression, static and dynamic torsion, expulsion, and subsidence) was conducted in accordance with ASTM F2077, ASTM F2267, expulsion, and "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices.
MRI testing was performed on subject devices per the following ASTM Standards:
- ASTM F2052:2015 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Maqnetic Resonance Environment
- ASTM F2119:2007 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- ASTM F2182:11a Standard Test Method of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2213:2017 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K162315, K112756, K173982, K041389
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
May 8, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Globus Medical Inc. Dr. Kelly Baker Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K190147
Trade/Device Name: COLOSSEUM™ Mesh Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: May 1, 2019 Received: May 2, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190147
Device Name COLOSSEUM™ Mesh
Indications for Use (Describe)
When used as a vertebral body replacement device in the cervical spine (C2-T1), COLOSSEUM™M Mesh devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used as a vertebral body replacement device in the thoracolumbar spine (T1-L5), COLOSSEUM™ Mesh devices are intended for use to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the vertebral body replacement device spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary: COLOSSEUM™ Mesh
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
| ---------- | ----------------------------------------------------------------------------------------- |
|---|
- Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
- May 1, 2019 Date Prepared:
- Device Name: COLOSSEUM™ Mesh
- Common Name: Spinal intervertebral fixation orthosis
- Classification: Per 21 CFR as follows: §888.3060 Spinal Intervertebral Fixation Orthosis Product Code(s): MQP, PLR Regulatory Class II, Panel Code 87
Primary Predicate: FORTIFY® Corpectomy Spacers (K162315)
Additional
Predicates: FORTIFY® Corpectomy Spacers (K112756, K173982) Synthes SynMesh (K041389)
Purpose:
The purpose of this submission is to request clearance for COLOSSEUM™ Mesh.
Device Description:
COLOSSEUM™ Mesh are devices that can be used as vertebral body replacement devices. The components of the implant include a preformed mesh cage and optional endcaps, which are available in a range of sizes and options to accommodate various surgical approaches and the anatomical needs of a wide variety of patients. The mesh and the endcaps are intraoperatively assembled to best fit individual requirements. Protrusions (teeth) on the superior and inferior surfaces of the endcaps grip the endplate of the adjacent vertebrae to resist expulsion.
COLOSSEUM™ Mesh implants are used to provide structural stability and as an adjunct to fusion in skeletally mature individuals following corpectomy or vertebrectomy in the cervical and thoracolumbar spine. Thoracolumbar mesh implants may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral approach. Cervical mesh implants are inserted using an anterior approach.
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COLOSSEUM™ Mesh implants are manufactured from titanium alloy as specified in ASTM F136. All implants are single use only.
Indications for Use:
When used as a vertebral body replacement device in the cervical spine (C2-T1), COLOSSEUM™ Mesh devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used as a vertebral body replacement device in the thoracolumbar spine (T1-L5), COLOSSEUM™ Mesh devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the vertebral body replacement device spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion. These devices are intended to be used with FDAcleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
Performance Data:
Mechanical testing (static and dynamic compression, static and dynamic torsion, expulsion, and subsidence) was conducted in accordance with ASTM F2077, ASTM F2267, expulsion, and "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices.
MRI testing was performed on subject devices per the following ASTM Standards:
- ASTM F2052:2015 Standard Test Method for Measurement of 0 Magnetically Induced Displacement Force on Medical Devices in the Maqnetic Resonance Environment
- ASTM F2119:2007 Standard Test Method for Evaluation of MR Image ● Artifacts from Passive Implants
- ASTM F2182:11a Standard Test Method of Measurement of Radio ● Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
5
- ASTM F2213:2017 Standard Test Method for Measurement of . Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.
Technological Characteristics:
Subject COLOSSEUM™ Mesh implants have similar technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.
Basis of Substantial Equivalence:
The subject COLOSSEUM™ Mesh implants have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject implants to the predicate device.