(149 days)
The provided text does not contain any K/DEN numbers for predicate devices. The section for "Predicate Device(s)" states "Not Found".
Not Found
No
The description focuses on the material, design, and mechanical properties of a physical implant, with no mention of software, algorithms, or AI/ML capabilities. The mention of radiopaque markers is for standard imaging identification, not AI-driven analysis.
Yes
The device is a vertebral body replacement system, which clearly indicates its therapeutic intent to replace and stabilize a damaged or unstable vertebral body.
No
The device is a vertebral body replacement system, which is an implantable medical device used to replace damaged or unstable vertebrae, not to diagnose a condition. Its function is therapeutic, not diagnostic.
No
The device description explicitly states the device is comprised wholly of unfilled PEEK Optima material and includes radiopaque markers, 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 Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that the Vista® P Vertebral Body Replacement System is a physical implant intended to replace a damaged vertebral body in the spine. It is surgically implanted inside the body.
- No Mention of Samples or Testing: The description does not mention any testing of biological samples or any diagnostic procedures performed on samples.
The device is a surgical implant used for structural support and replacement within the body, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Vista® P 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 Vista® P Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Vista® P Vertebral Body Replacement may be used with bone graft.
Product codes
MPQ
Device Description
The Vista" P Vertebral Body Replacement (VBR) System is comprised wholly of unfilled PEEK Optima material. This VBR system accommodates 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 device must be implanted in pairs and cannot be used singly.
The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability. Radiopaque markers are press fit into the device to identify the boundary of the device in intra and postoperative imaging.
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 subject Vista" P devices were mechanically tested per established ASTM standards. The results of this performance testing demonstrated that the device will perform as intended and is equivalent to the cited predicate devices.
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter Name
And Address: | Zimmer Trabecular Metal Technology, Inc.
80 Commerce Drive
Allendale, New Jersey 07401-1600 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Robert A Poggie, PhD SEP 2 2 2006 |
| Phone Number: | (201) 818-1800 x122 |
| Fax Number: | (973) 884-6082 |
| Date Prepared: | April 25, 2006 |
| Device Trade Name: | Vista ® P Vertebral Body Replacement System |
| Device Common Name: | Vertebral Body Replacement Device |
| Classification Number,
Product Code, & Name: | 21 CFR § 888.3060
MPQ; Spinal Vertebral Body Replacement Device |
Substantial The term "substantial equivalence" as used in this 510(k) notification is Equivalence: limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
The Vistas P Vertebral Body Replacement System is designed to be used as a Device Description: replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.
The Vista" P Vertebral Body Replacement (VBR) System is comprised wholly of unfilled PEEK Optima material. This VBR system accommodates 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 device must be implanted in pairs and cannot be used singly.
The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability. Radiopaque markers are press fit into the device to identify the boundary of the device in intra and postoperative imaging.
1
Indications for Use: The Vista P 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 turnor or trauma (i.e., fracture). The Vista P Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Vista" P Vertebral Body Replacement may be used with bone graft.
Device Technological The device is similar in design, geometry and sizing to the predicate Characteristics and devices and possesses identical indications for use. The unfilled PEEK Comparison to Optima LT-1 material has been used in cited predicates for the same Predicate Device: intended and indications for use.
Performance Data: The subject Vista" P devices were mechanically tested per established ASTM standards. The results of this performance testing demonstrated that the device will perform as intended and is equivalent to the cited predicate devices.
Conclusion:
The Vista P Vertebral Body Replacement System is substantially equivalent to the predicate devices identified in this premarket notification.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal features the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping figures or abstract shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2006
Zimmer Trabecular Metal Technology, Incorporated c/o Dr. Robert A. Poggie 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K061155
Trade Name: Vista-P Device Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 28, 2006 Received: August 29, 2006
Dear Dr. Poggie:
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.
3
Page 2 - Dr. Robert A. Poggie
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. 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 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.
Ybarbare friehund
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K061155: Zimmer Trabecular, Vista-P Device 510k Number:
Indications For Use
The Vista® P 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 Vista® P Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Vista® P Vertebral Body Replacement may be used with bone graft.
OR...
Prescription Use >