(64 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device replaces a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which is a therapeutic intervention to restore stability and function to the spine.
No
The device is a vertebral body replacement system, an implantable device used to replace damaged vertebrae, not to diagnose a condition.
No
The device description explicitly states it is comprised wholly of Trabecular Metal Porous Tantalum and is a physical implant for vertebral body replacement, indicating it is a hardware device.
No, 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 device intended for use in the thoracolumbar spine (T1 -- L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma". This describes a surgical implant used directly within the human body.
- Device Description: The description details a physical implant made of Trabecular Metal Porous Tantalum, designed to be surgically placed in the spine.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with biological specimens in this way.
The information provided describes a medical device used for surgical implantation, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Zimmer TMT 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 (comma separated list FDA assigned to the subject device)
MQP
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.
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)
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: Static compression, Dynamic compression, Static torsion, Dynamic torsion, and Abrasion.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K010378, K021025, K021967, K022563, K031823, K032527, K051196
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 2 3 2005
510(k) SUMMARY Trabecular Metal Vertebral Body Replacement System
| 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: | July 11, 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 Orthrosis |
Device The Trabecular Metal Vertebral Body Replacement System is Description: 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.
- Indications for Use: The Zimmer TMT 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 The device is unique in comparison to predicates for this Characteristics and indication with regard to its geometry. The material has been Comparison to used in cited predicates for other applications. The Zimmer TMT Predicate Device: Vertebral Body Replacement System is substantially equivalent previously cleared components of this same system to (K010378, K021025, K021967, K022563, K031823, K032527 and K051196). The size range is comparable to the Signus
1
KU51978 Trabecular Metal Vertebral Body Replacement Daye 2 of 2 Zimmer TMT ....... Special 510(k) Premarket Notification Medical implants described in K022793, K041888 and K043316. Predicate devices that are a part of the Trabecular Metal Performance Data: Vertebral Body Replacement System were tested per applicable standards (reference K010378). 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: 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
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 07401-1600
Rc: K051978
. K051776
Trade/Device Name: Zimmer Trabecular Metal Vertebral Body Replacement System Regulation Name: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: July 20, 2005 Received: July 21, 2005
SEP 2 3 2005
Dear Ms. Halevi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regars) to regally the Medical Device American procession in the commerce pror to Hay 20, 2017 - 3 de nees that have boom require approval of a premarket approval application (PMA). and Costiene Ace (110) that be nevice, subject to the general controls provisions of the Act. The r our may, mereroro, manus of the Act include requirements for annual registration, listing of general controls proficions 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 it may of sucject to cash of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA ean of tound in the Overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be actives made a determination that your device complies with other requirements of the Act that I Dri has made a actual regulations administered by other Federal agencies. You must or any I cacal statutes and regendents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF It 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 – Ms. Marci Halevi
This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you to organ manisang of substantial equivalence of your device to a legally prematics notification. "The sesults 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 rryou desire 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 miornational 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,
2
- 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): _K05-1978
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 ropidoo a conalization Metal Vertebral Body Replacement is intended from tradition of the rital internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
The Zimmer TMT Trabecular Metal Vertebral Body Replacement System
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K051978
(Posted November 13, 2003)
Page | of l