K Number
K073502
Device Name
VERTEBRON VBR SYSTEM
Manufacturer
Date Cleared
2008-03-24

(102 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, such as the VERTEBRON PSS Pedicle Screw System.
Device Description
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.
More Information

No
The 510(k) summary describes a passive interbody fusion device made of PEEK or titanium, with no mention of software, algorithms, or any AI/ML related terms.

Yes

The device, "VERTEBRON Interbody Fusion System," is explicitly described as a system "Implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems" for fusion, directly indicating its role in treating degenerative disc disease. This is a therapeutic action.

No

Explanation: The device is an interbody fusion system designed to provide structural support and facilitate spinal fusion in patients with degenerative disc disease. It is a therapeutic device, not a diagnostic one, as it does not diagnose medical conditions.

No

The device description clearly states it is comprised of physical components made from PEEK and Tantalum, which are hardware materials.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to treat a physical condition (degenerative disc disease).
  • Device Description: The description details a physical implant made of PEEK or titanium, designed to be surgically placed in the spine. It talks about its shape, material properties, and how it facilitates bone fusion.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for treatment.

N/A

Intended Use / 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.

Product codes

MAX

Device Description

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

one or two contiguous spinal levels from L2-S1

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Lanx K073144, Globus Medical K072970, Innovative Spine K072120, Abbott Spine K073202

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

K073502

Page 1 of 2

    1. 510(k) Summary or 510(k) Statement

| SUBMITTER: | MAR 2 4 2008
VERTEBRON Inc.
80 Hathaway Drive
Stratford, CT 06615
(203) 380-9340 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luis Nesprido
Senior 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 K073144
Globus Medical K072970
Innovative Spine K072120
Abbott Spine K073202 |
| DEVICE DESCRIPTION: | 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. |

1

K073502

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

2

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.

3

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

4

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