(170 days)
The EXPANSE Vertebral Body Replacement (VBR) Device is indicated for use in the thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body which has been resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture).
The EXPANSE VBR Device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The EXPANSE VBR Device is intended to be used with bone graft and supplemental fixation. The supplemental internal fixation systems that may be used with the EXPANSE VBR Device include the Zodiac Polyaxial Pedicle Screw System, the Expedium Spinal System, the Expedium Anterior system, and the CD Horizon Spinal System, or equivalent systems.
The EXPANSE VBR Device may be implanted singularly or in pairs.
The EXPANSE device is manufactured from implantable grade titanium 6Al-4V alloy that conforms to ASTM F- 136. The device consists of opposing surfaces that make contact with the bony endplates of the vertebral bodies and can be expanded 2 mm in height. Following expansion, a shim is inserted between the opposing surfaces to provide mechanical integrity of the implanted device. Each surface in contact with the bony endplates is roughened to provide positive engagement with the endplates to resist rotation and migration.
The EXPANSE is offered in five heights and a single length to provide the surgeon anatomic flexibility.
The regulatory submission describes the EXPANSE Vertebral Body Replacement Device and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a 510(k) summary, not a detailed clinical or performance study report. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting novel performance metrics against specific acceptance criteria.
Therefore, I cannot extract the requested information, as performance data, sample sizes, ground truth establishment, expert qualifications, and study designs are not typically part of the provided 510(k) summary. The document primarily focuses on device description, indications for use, and a declaration of substantial equivalence based on intended use, scientific technology, materials, and design, supported by biocompatibility assessment and bench testing without specifying detailed results or acceptance criteria.
{0}------------------------------------------------
.
510(K) Summary of Safety and Equivalency
| Submitter: | Flexuspine, Inc.120 W. Fifth StreetSuite 200Tyler, TX 75701 |
|---|---|
| Contact Person: | Corey HarboldVice PresidentFlexuspine, Inc.120 W. Fifth StreetSuite 200Tyler, TX 75701Main: 1-888-692-0277Fax: 903-596-8270charbold@flexuspine.com |
| Date Prepared: | April 15, 2005 |
| Trade Name: | EXPANSE Vertebral Body Replacement Device |
| Classification Nameand Number: | Spinal Intervertebral body fixation orthosis21 CFR 888.3060Class II |
| Product Code: | MQP |
| Predicate Device(s): | The Flexuspine, Inc. Vertebral Body Replacement (VBR)Device is substantially equivalent to the TETRIS™ SpinalImplant, manufactured by Signus Medical LLC (K022793),the Theken CPOD/LPOD Vertebral Body ReplacementSystem, manufactured by Theken Surgical (K032064), andthe Spinal Concepts Inc. Coda®, manufactured by SpinalConcepts, Inc. (K033663). |
| Device Description: | The EXPANSE device is manufactured from implantablegrade titanium 6Al-4V alloy that conforms to ASTM F-136. The device consists of opposing surfaces that makecontact with the bony endplates of the vertebral bodies andcan be expanded 2 mm in height. Following expansion, ashim is inserted between the opposing surfaces to providemechanical integrity of the implanted device. |
:
{1}------------------------------------------------
K0502977-
page 2 of 2
Each surface in contact with the bony endplates is roughened to provide positive engagement with the endplates to resist rotation and migration.
The EXPANSE is offered in five heights and a single length to provide the surgeon anatomic flexibility.
Indications For Use: The EXPANSE Vertebral Body Replacement Device is indicated for use in the thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body which has been resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture).
EXPANSE VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. EXPANSE VBR is intended to be used with bone graft and supplemental fixation. The supplemental internal fixation systems that may be used with the EXPANSE VBR Device include the Zodiac Polyaxial Pedicle Screw System, the Expedium Spinal System, the Expedium Anterior system, and the CD Horizon Spinal System, or equivalent systems.
The EXPANSE VBR Device may be implanted singularly or in pairs.
Biocompatibility assessment and bench testing have been completed and support the safety and equivalency of the Flexuspine, Inc. Vertebral Body Replacement (VBR) Device.
The Flexuspine, Inc. Vertebral Body Replacement (VBR) System is substantially equivalent in intended use, scientific technology, materials and design to predicate devices listed in this submission.
Intended Use:
Functional and Safety Testing:
Conclusion:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling the image. The central image is a stylized representation of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2005
Mr. Corev Harbold Vice President Flexuspine, Inc. 120 West Fifth Street, Suite 200 Tyler. Texas 75701
Re: K050997
Trade/Device Name: EXPANSE Spinal Vertebral Body Replacement Device (VBR) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MQP Dated: September 13, 2005 Received: September 15, 2005
Dear Mr. Harbold:
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. Corey Harbold
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
Mark N. Melkerson, Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known): TBD
Device Name: EXPANSE Vertebral Body Replacement Device
Indications For Use: The EXPANSE Vertebral Body Replacement (VBR) Device is indicated for use in the thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body which has been resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture).
The EXPANSE VBR Device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The EXPANSE VBR Device is intended to be used with bone graft and supplemental fixation. The supplemental internal fixation systems that may be used with the EXPANSE VBR Device include the Zodiac Polyaxial Pedicle Screw System, the Expedium Spinal System, the Expedium Anterior system, and the CD Horizon Spinal System, or equivalent systems.
The EXPANSE VBR Device may be implanted singularly or in pairs.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Flexuspine, Inc. | Traditional 510(k) - EXPANSE VBR Device | Page 1 of 32 |
|---|---|---|
| 4/15/2005 | 510(k) Number Confidential K 050997 |
§ 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.