(102 days)
The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems, such as the VERTEBRON PSS Pedicle Screw System.
The VERTEBRON Interbody Fusion System consists of various heights, angles and configurations (i.e., square, rectangular D-shaped, etc.). The device is use singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy.
The VERTEBRON Interbody Fusion System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM 2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.
The VERTEBRON Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F560) are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively.
The material used is PEEK ASTM F2026-07e1 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy (TI-6AI-4V) that conforms to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
The VERTEBRON Interbody Fusion System is an intervertebral body fusion device. The acceptance criteria and the study performed for this device are described below, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Method |
|---|---|---|
| Conformity to ASTM F2077-03 for Interbody Fusion Devices (Mechanical Static and Dynamic Testing) | Meets mechanical performance requirements for interbody fusion devices | ASTM F2077-03: "Standard Test Methods for Intervertebral Body Fusion Devices" |
| Conformity to ASTM F2267 for Measuring Load Induced Subsidence | Meets load-induced subsidence resistance requirements | ASTM F2267: "Standard Test Methods for Measuring Load Induced Subsidence of an Interbody Fusion Device Under Static Axial Compression" |
| Material Specification: PEEK ASTM F2026-07e1 | Device comprised of PEEK conforming to ASTM F2026-07e1 | Material testing and documentation |
| Material Specification: Titanium Alloy (TI-6AI-4V) ASTM F136 | Not explicitly stated as used in this device's description, but acceptable if used. PEEK described as primary material due to radiolucent properties. | Material testing and documentation (if applicable) |
| Material Specification: Unalloyed Tantalum ASTM F560 (for markers) | Tantalum wire markers conforming to ASTM F560 are inserted. | Material testing and documentation |
| Implantation Approach Compatibility | Verified for use via anterior or posterior approach | Not a performance criteria directly, but an intended use parameter. |
| Compatibility with Supplemental Fixation Systems | Combined with cleared supplemental fixation systems (e.g., VERTEBRON PSS Pedicle Screw System) | Not a performance criteria for the device itself, but a condition of use. |
2. Sample Size for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a test set with human subject data for efficacy or safety comparisons. The studies mentioned are primarily bench testing for mechanical properties.
- Sample Size: Not applicable for human data. For mechanical testing, the sample size would be determined by the ASTM standards (e.g., number of devices tested). This specific detail is not provided.
- Data Provenance: Not applicable for human data. For mechanical testing, the data would be generated from laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The studies referenced are mechanical bench tests against established ASTM standards, not clinical studies requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a medical implant (interbody fusion system), not an AI or imaging diagnostic device where MRMC studies are typically performed.
6. Standalone Performance Study
Yes, a standalone study in the context of mechanical performance was conducted. The device's mechanical properties were evaluated in a standalone manner (i.e., the device itself, without human interaction influencing performance in the test) against the specified ASTM standards. This is a "standalone" evaluation of the device's physical and mechanical characteristics.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device was based on widely accepted engineering and material standards (ASTM F2077-03 and ASTM F2267 for mechanical properties; ASTM F2026-07e1, ASTM F136, and ASTM F560 for material specifications). The device was evaluated against these predefined, objective standards for mechanical strength and material composition.
8. Sample Size for the Training Set
Not applicable. This device is an implanted medical device, not an AI or machine learning algorithm that requires a training set. The performance evaluation relies on engineering principles and bench testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML component, there is no training set or ground truth required to be established for one.
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- 510(k) Summary or 510(k) Statement
| SUBMITTER: | MAR 2 4 2008VERTEBRON Inc.80 Hathaway DriveStratford, CT 06615(203) 380-9340 |
|---|---|
| CONTACT PERSON: | Luis NespridoSenior Manager Regulatory Affairs |
| DATE PREPARED: | September 10, 2007 |
| CLASSIFICATION NAME: | 21 CFR §888.3080 Intervertebral Body Fusion Device |
| COMMON NAME: | Intervertebral Body Fusion Device |
| PROPRIETARY NAME: | VERTEBRON Interbody Fusion System |
| PREDICATE DEVICES: | Lanx K073144Globus Medical K072970Innovative Spine K072120Abbott Spine K073202 |
| DEVICE DESCRIPTION: | The VERTEBRON Interbody Fusion System consists ofvarious heights, angles and configurations (i.e., square.rectangular D-shaped, etc.). The device is use singly or inpairs to better approximate the anatomical variationsobserved in different vertebral levels and/or patientanatomy. |
| The VERTEBRON Interbody Fusion System is comprisedof a variety of components fabricated and manufacturedfrom Polyetheretherketone (PEEK) as described by ASTM2026. This material is utilized due to its radiolucentproperties, which aid the surgeon in determining if fusion inthe operative site has occurred. | |
| The VERTEBRON Interbody Fusion System has a hollowchamber to permit packing with autogenous bone graft tofacilitate fusion, but is of sufficient strength to providecolumn support even in the absence of fusion forprolonged periods. The superior and inferior surfaces ofthe construct have a pattern of teeth to provide increasedstability and to help prevent movement of the device.Tantalum wire markers (ASTM F560) are inserted into thecomponents to give surgeons a visual aid in determiningthe location of the implant, both inter and post-operatively. |
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Page 2 of 2
INTENDED USE: The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems include, such as the VERTEBRON PSS Pedicle Screw System.
The material used is PEEK ASTM F2026-07e1 Standard MATERIALS: Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy (TI-6AI-4V) that conforms to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
SUBSTANTIAL EQUIVALENCE:
Performance evaluation was conducted in accordance with ASTM F2077-03 - Test Methods for Interbody Fusion Devices and ASTM F2267 – Standard Test Methods for Measuring Load Induced Subsidence of an Interbody Fusion Device Under Static Axial Compression
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2008
Vertebron, Incorporated % Mr. Luis Nesprido Senior Manager, Regulatory Affairs 80 Hathaway Drive Stratford, CT 06615
K073502 Re: Trade/Device Name: Vertebron Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX
Dated: February 15, 2008 Received: February 21, 2008
Dear Mr. Nesprido:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Luis Nesprido
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. Indications for Use Statement
510(k) Number (if known):
Device Name:
VERTEBRON Interbody Fusion System
Indications For Use:
The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems, such as the VERTEBRON PSS Pedicle Screw System.
Prescription Use: × AND / OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use: (21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Juta
sion Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K073502
§ 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.