(148 days)
The Stansion Matrix™ ("Stansion Matrix") is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a portion of a diseased vertebral body that is resected or excised for the treatment of tumors, where the defect is contained within a single vertebral body, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is also indicated for treating fractures of the thoracic and lumbar spine. The Stansion Matrix 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 of time. The device is intended for use with supplemental rigid posterior pedicle screw fixation.
The device is a single piece titanium VBR that is open on all sides to maximize bone ingrowth. It is available in three sizes. The device is implanted via the posterior approach, according to similar methods as the predicates. An insertion tool is provided with the device to facilitate its implantation.
The provided text is a 510(k) summary for the Stansion Matrix™ Vertebral Body Replacement device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance from studies, or details about the rigorous testing methodologies often associated with AI/software devices.
The Stansion Matrix is a physical medical device (vertebral body replacement), not an AI or software device. Therefore, the questions related to AI/software performance metrics (like acceptance criteria for algorithms, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable to the content provided.
The document discusses the physical characteristics of the device and its similarity to predicate devices, focusing on materials, shape, and method of use to establish substantial equivalence. Performance testing is only mentioned generally: "Any minor differences in technological features do not raise new issues of safety or effectiveness, as confirmed by performance testing." It does not provide details of such tests.
Therefore, I cannot fulfill the request as the input document does not contain the necessary information about acceptance criteria or studies proving device performance from the perspective of an AI/software device.
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FEB 1 8 2005
KO42600
510(k) SUMMARY
SpineWorks LLC's Stansion Matrix™
Submitter's Name, Address, Telephone Number, And Contact Person
SpineWorks, LLC 2802 Florida Street Huntington Beach, CA 92648 (805) 797-3003 Phone: Phone: Facsimile: (714) 960-5250
Douglas W. Neary Contact Person:
Date Prepared
August 2004
Name of the Device
Stansion Matrix™ Vertebral Body Replacement
Common or Usual Name
Vertebral Body Replacement (MQP)
Classification Name
Spinal Vertebral Body Replacement
Predicate Devices
- Interpore Cross International GEO™ Structure .
- Depuy AcroMed, Inc. Stackable Cage™ System .
- Osteotech, Inc. VBR .
- Orthovita Endoskeleton TA VBR .
Intended Use
The Stansion Matrix is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a portion of a diseased vertebral body that is resected or excised for the treatment of tumors, where the defect is contained within a single
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K042600 Page Zof Z
vertebral body, in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is also indicated for treating fractures of the thoracic and lumbar spine. The Stansion Matrix 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 of time. The device is intended for use with supplemental rigid posterior pedicle screw fixation.
Principles of Operation
The device is a single piece titanium VBR that is open on all sides to maximize bone ingrowth. It is available in three sizes. The device is implanted via the posterior approach, according to similar methods as the predicates. An insertion tool is provided with the device to facilitate its implantation.
Technological Characteristics
The technological characteristics of the Stansion Matrix are very similar to the predicates with respect to shape, sizes, materials, and method of use. Like several of the predicates, the Stansion Matrix is made of titanium alloy. The minor differences in the design and the range of available sizes compared to the predicates do not raise any new questions of safety or effectiveness.
Summary Basis for the Finding of Substantial Equivalence
The Stansion Matrix has the same intended use and very similar indications for use to the predicate devices. The Stansion Matrix also is similar to the predicates with respect to its shape, size range, materials, and method of use. Any minor differences in technological features do not raise new issues of safety or effectiveness, as confirmed by performance testing. Therefore, the Stansion Matrix is substantially equivalent to the predicates.
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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 features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Spine Works, L.L.C. C/o Jonathan S. Kahan, Esq. Hogan & Harston L.L.P. 555 13" Street N.W. Washington, DC 20004
Re: K042600 Trade/Device Name: Stansion MatrixTM Regulation Number: 21 CFR 888.3060
Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 21, 2005 Received: January 21, 2005
Dear Mr. Kahan:
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 Codc 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. Kahan
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" (21 CFR 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.
Sincercly vours.
D. Mark A. Wilkerson
Celia M. Witten, Ph.D., M.D. Director,
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K042600
Device Name: Stansion Matrix™
Indications for Use: The Stansion Matrix™ ("Stansion Matrix") is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a portion of a diseased vertebral body that is resected or excised for the treatment of tumors, where the defect is contained within a single vertebral body, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is also indicated for treating fractures of the thoracic and lumbar spine. The Stansion Matrix 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 of time. The device is intended for use with supplemental rigid posterior pedicle screw fixation.
Prescription Use _ ど (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mike A. Mulkerson
Division of General, Restorative, and Neurological Devices
Page l_of_l
510(k) Number K042600
§ 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.