(27 days)
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The DePuy AcroMed VBR System 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 DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the DePuy AcroMed VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).
Additional size components in various sizes and footprints. The DePuy AcroMed VBR System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.
The provided text describes a medical device, the DePuy AcroMed VBR System, and its indications for use in the context of a 510(k) premarket notification. It does NOT contain information about acceptance criteria, device performance metrics, or any studies demonstrating that the device meets specific performance criteria.
The document states: "Performance data were submitted to characterize the additional components of the DePuy AcroMed VBR System." However, the actual performance data, acceptance criteria, or details of the study itself are not included in the provided text.
Therefore, according to the input, I cannot furnish the requested information.
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DePuy AcroMed VBR System
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KO31635 510(k) Summary IX. DePuy AcroMed, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780 Lisa A. Gilman CONTACT PERSON: May 21, 2003 DATE PREPARED: CLASSIFICATION NAME: Implant, Fixation Device Spinal Intervertebral Body Fixation Orthosis Device PROPRIETARY NAME: DePuy AcroMed VBR System DePuv AcroMed VBR System (K030833) PREDICATE DEVICES: Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522) Devex Mesh System (K023835) Additional size components in various sizes and DEVICE DESCRIPTION: footprints. The DePuy AcroMed VBR System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification. The DePuy AcroMed VBR System is indicated for use INTENDED USE: in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the to achieve anterior treatment of tumors, decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The DePuy AcroMed VBR System 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.
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The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the DePuy AcroMed VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR. University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).
Carbon-fiber reinforced polymer MATERIALS:
PERFORMANCE DATA:
Performance data were submitted to characterize the additional components of the DePuy AcroMed VBR System.
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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2003
Mr. Frank Maas Regulatory Affairs Director DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K031635
Trade/Device Name: DePuy AcroMed VBR System Regulation Numbers: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Codes: MQP Dated: March 23, 2003 Received: March 28, 2003
Dear Mr. Maas:
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. Frank Maas
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Milliken
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 111.
K031635 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
DePuy AcroMed VBR System Device Name:
Indications For Use:
The indications for use for the modified devices described in this submission are the same as those for the DePuy AcroMed VBR System. The indications are as follows:
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The DePuy AcroMed VBR System 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 DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the DePuy AcroMed VBR System include DePuy AcroMed titanium plate or rod svstems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX. MONARCH, and Profile).
Mark M. Melkerson
ivision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | |
|---|---|
| OR Over-The-Counter Use: | |
| (Per 21 CFR 801.109) |
§ 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.