(165 days)
Not Found
Not Found
No
The summary describes a physical implant device for spinal surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "Vertebral Body Replacement System" intended to replace "collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture)," which directly addresses a health problem for therapeutic purposes.
No
The device is described as a "Vertebral Body Replacement System" intended to replace damaged or unstable vertebral bodies. Its purpose is to physically replace a body part, not to diagnose a condition.
No
The device description explicitly states it is comprised of physical components made of Trabecular Metal Porous Tantalum, which are implanted into the body. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "vertebral body replacement system" for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. This is a surgical implant used directly within the body.
- Device Description: The description confirms it's a "replacement for a diseased or damaged vertebral body and the adjacent disc."
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or analysis of biological samples.
Therefore, the Trabecular Metal Vertebral Body Replacement System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
Product codes
MOP
Device Description
The Trabecular Metal Vertebral Body Replacement (VBR) System is designed to be used as a replacement for a diseased or damaged vertebral body and the adjacent disc when spinal surgery is indicated. The Trabecular Metal VBR System is wholly comprised of Trabecular Metal Porous Tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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)
The results of testing and analyses conducted demonstrate that the worst cases of the proposed System adequately meet the predetermined requirements established for its mechanical performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Page 1 of 2.
510(k) Summary
AUG 3 1 2007
| Submitter: | Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Road
Parsippany, New Jersey 07054 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer P. Harakal
Senior Specialist, Regulatory Affairs
Telephone: (973) 576-0133
Fax: (973) 884-8795 |
| Date: | March 16, 2007 |
| Trade Name: | Trabecular Metal™ Vertebral Body Replacement System |
| Common Name: | Vertebral Body Replacement Device |
| Classification Name and
Reference: | Spinal Intervertebral Body Fixation Orthosis
21 CFR § 888.3060, MOP |
DEVICE DESCRIPTION
The Trabecular Metal Vertebral Body Replacement (VBR) System is designed to be used as a replacement for a diseased or damaged vertebral body and the adjacent disc when spinal surgery is indicated. The Trabecular Metal VBR System is wholly comprised of Trabecular Metal Porous Tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.
INDICATIONS FOR USE
The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE(S)
Zimmer Trabecular Metal Technology, Inc. has submitted documentation demonstrating the substantial equivalence of the proposed System to its predicate devices. The subject
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Page 2 of 2
System is similar to its predicate devices with respect to intended use/indications for use, materials, and basic principles of operation.
PERFORMANCE DATA
The results of testing and analyses conducted demonstrate that the worst cases of the proposed System adequately meet the predetermined requirements established for its mechanical performance.
SUBSTANTIAL EQUIVALENCE
The Trabecular Metal™ Vertebral Body Replacement System is substantially equivalent to its predicate devices with respect to intended use/indications for use, technological characteristics and basic principles of operation. As demonstrated by supporting performance data, these technological differences do not present any new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2007
Zimmer Trabecular Metal Technology % Ms. Jennifer P. Harakal Senior Regulatory Affairs Specialist 10 Pomeroy Road Parsippany, NJ 07054
Re: K070754
Trade/Device Name: Trabecular Metal™ Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: July 18, 2007 Received: July 19, 2007
Dear Ms. Harakal:
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 - Ms. Jennifer P. Harakal
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 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 A. Milken
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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Indications for Use
510(k) Number (if known): _ K0 70754
Device Name: Trabecular Metal" Vertebral Body Replacement System
Indications for Use:
The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Marle A. Miller
(Division Sign-Off) (Division Sign of General, Restorative, and Neurological Devi
510(k) Number