(27 days)
No
The summary describes a mechanical implant for vertebral body replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a vertebral body replacement system, which directly treats a damaged or unstable vertebral body by replacing it due to tumor or trauma. This direct intervention for a medical condition qualifies it as a therapeutic device.
No
Explanation: The device is a vertebral body replacement system, which is a surgical implant designed to replace a damaged or diseased vertebral body. Its intended use is therapeutic (replacement) rather than diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states the device is comprised wholly of Trabecular Metal Porous Tantalum and is available in various physical dimensions, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a physical implantable device (a vertebral body replacement) intended to be surgically placed in the spine to replace a damaged vertebral body. It is a structural device used for mechanical support and stabilization.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is entirely mechanical and structural within the body.
Therefore, based on the provided information, the Trabecular Metal Vertebral Body Replacement System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Trabecular Metal Vertebral Body Replacement System is a vertebral body replacement device 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
MQP
Device Description
The Trabecular Metal Vertebral Body Replacement System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.
The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability.
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
Predicate devices that are a part of the Trabecular Metal Performance Data: Vertebral Body Replacement System were tested per applicable standards (reference K010378 and current submission). Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicate devices. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding:
- Expulsion, .
- Static compression, .
- Dynamic compression, .
- Static torsion, .
- Dynamic torsion, and
- . Abrasion.
Key Metrics
Not Found
Predicate Device(s)
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
510(k) SUMMARY Trabecular Metal Vertebral Body Replacement System
| Trabecular Metal Vertebral Body Replacement System Page 1 of 2 | |
|---|---|
| Submitter Name | |
| And Address: | Zimmer Trabecular Metal Technology, Inc. |
| 80 Commerce Drive | |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Marci Halevi |
| Phone Number: | (201) 818-1800 ext. 507 |
| Fax Number: | (973) 829-0825 |
| Date Prepared: | October 17, 2005 |
| Device Trade Name: | Trabecular Metal Vertebral Body Replacement System |
| Device Common Name: | Vertebral Body Replacement Device |
| Classification Number | |
| and Name: | 21 CFR § 888.3060. |
| Spinal Intervertebral Body Fixation Orthosis | |
| Device | |
| Description: | The Trabecular Metal Vertebral Body Replacement System is |
| designed to be used as a replacement for a single diseased or | |
| damaged vertebral body and the adjacent disc when spinal surgery | |
| through an anterior approach is indicated. |
The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.
The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability.
- The Zimmer TMT Trabecular Metal Vertebral Body Replacement Indications for Use: 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 Technoloqical The device is unique in comparison to predicates for this Characteristics and indication with regard to its geometry. The material has been used in cited predicates for other applications. The Zimmer TMT Comparison to Predicate Device: Vertebral Body Replacement System is substantially equivalent to previously cleared components of this same system (K010378, K051196 and K051978).
1
- Predicate devices that are a part of the Trabecular Metal Performance Data: Vertebral Body Replacement System were tested per applicable standards (reference K010378 and current submission). Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicate devices. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding:
- Expulsion, .
- Static compression, .
- Dynamic compression, .
- Static torsion, .
- Dynamic torsion, and
- . Abrasion.
Conclusion:
TMT Trabecular Metal The Zimmer Vertebral Body Replacement System is substantially equivalent to the predicate devices identified in this premarket notification.
K052950 ge 2 of 2
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized representation of a human figure, composed of three curved lines. The figure is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
NOV 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology, Inc. 80 Commerce Drive Allendale, New Jersey 07401
Re: K052950
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: MQP Dated: October 19, 2005 Received: October 20, 2005
Dear Ms. Halevi:
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. Marci Halevi
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and w yourse 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 If you dome 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 other general information on Jon 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 પ્રેમ 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): _ K05 2950
Device Name: The Zimmer TMT Trabecular Metal Vertebral Body Replacement System
Indications for Use:
The Trabecular Metal Vertebral Body Replacement System is a vertebral body replacement device 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 _____________________________________________________________________________________________________________________________________________________________ (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
(Division Sign-Off Division of General, Rest rative. and Neurological Devices
510(k) Number_KOSQ950