(83 days)
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Not Found
No
The summary describes a mechanical implant for spinal surgery and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
The device is a vertebral body replacement implant designed to restore mechanical integrity, not to provide therapy.
No
Explanation: The device is a vertebral body replacement implant designed to restore mechanical integrity to the spine after a vertebral body has been removed. It is a therapeutic device, not one used for diagnosis.
No
The device description clearly states the Phenix™ VBR is a "rectangular implant with an open center comprised of titanium," indicating it is a physical hardware device, 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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Phenix™ VBR Function: The description clearly states that the Phenix™ VBR is a vertebral body replacement device intended for surgical implantation in the thoracic spine. It is a physical implant designed to restore mechanical integrity.
The intended use and device description are entirely focused on a surgically implanted medical device, not a diagnostic test performed on bodily specimens.
N/A
Intended Use / Indications for Use
The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems that have been labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MQP, 888.3060
Device Description
The Phenix™ VBR is a rectangular implant with an open center comprised of titanium, (Ti-6Al-4V). The Phenix™ VBR's superior and inferior ends have ridges to interface with the vertebral endplates to resist rotation and migration. The implant is available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. The Titanium allows for radiographic visualization.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracic spine (i.e., T1-L5)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was completed to characterize the device.
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.
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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.
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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).
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§ 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
Phenix™ Vertebral Body Replacement 510(k) Application
.
| Company:
Company Name
Street address
City, State Zip Code
Telephone | Spinal Devices, LLC
1155 Allgood Road, Suite 6
Marietta, GA 30062
770-874-0935 | UC |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| Company Contact: | Tim Lusby | |
| Common Name | Spinal vertebral body replacement device | |
| Trade Name: | Phenix™ VBR | |
| Classification: | Class II | |
| Product Code; | MQP, 888.3060 | |
| Device Description: | The Phenix™ VBR is a rectangular implant with an
open center comprised of titanium, (Ti-6Al-4V). The
Phenix™ VBR's superior and inferior ends have
ridges to interface with the vertebral endplates to
resist rotation and migration. The implant is available
in a range of sizes, as well as flat and lordotic angled
implants to accommodate variations in patient's
anatomy. The Titanium allows for radiographic
visualization. | |
| Intended Use: | The Phenix™ VBR is a vertebral body replacement
device intended for use in the thoracic spine (i.e., T1-
L5) to replace a collapsed, damaged or unstable
vertebral body resected or excised (i.e., partial or total
vertebrectomy) due to tumor or trauma (i.e., fracture).
The Phenix™ VBR is designed to restore the
mechanical integrity of the anterior, middle and
posterior spinal column even in the absence of fusion
for a prolonged period. The Phenix™ VBR is intended
for use with supplemental spinal fixation systems that
have been labeled for use in the thoracic spine. The
interior of the Phenix™ VBR may be packed with bone
graft. | |
| Predicate Device: | Based on the same indications for use, intended use,
design and performance to the predicate device,
substantial equivalence was determined. | |
| Performance Data: | Testing was completed to characterize the device. | |
16072029
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, official design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
New Business Development, LLC % Mr. Tim Lusby General Manager, Member 1155 Allgood Road, Suite 6 Marietta, Georgia 30062
OCT 1 5 2007
K072029 Trade/Device Name: Phenix Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 31, 2007 Received: September 4, 2007
Dear Mr. Lusby:
Re:
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.
2
Page 2 - Mr. Tim Lusby
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Barbara Buchur
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indication for Use Statement
510(k) Number (if known): K072029
Device Name: Phenix™ Vertebral Body Replacement
Indications for Use:
The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in moshanisal intogray of the prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems which are labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with autograft bone.
Prescription Use X Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara BuchR
- Restorative, and Neurological Devices
510(k) Number: K072029