(26 days)
Not Found
None
No
The device description and intended use focus on a mechanical implant for spinal support, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which directly addresses a pathological condition and restores normal function.
No
The device is described as a "Vertebral Body Replacement System" intended for surgical implantation to replace a damaged vertebral body, not to diagnose a condition.
No
The device description explicitly states it is composed of a flanged VBR body with screw holes and fixation screws, made from titanium and PEEK, indicating it is a physical implant and 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, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided information clearly describes a surgical implant intended to replace a vertebral body in the spine. It is a physical device implanted within the body to provide structural support.
- Lack of Diagnostic Function: There is no mention of this device performing any tests on biological samples or providing diagnostic information. Its function is purely structural and mechanical.
Therefore, based on the provided information, the Quantum Vertebral Body Replacement System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantum Vertebral Body Replacement System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
Product codes
MQP
Device Description
The Quantum Vertebral Body Replacement System is composed of a flanged VBR body with screw holes and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry and teeth on its external surfaces. Screws pass through screw holes and affix to bone to help prevent implant migration. The devices are available in a multitude of sizes and are made from titanium and polyetheretherketone (PEEK).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or 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)
Mechanical testing indicates that the Quantum Vertebral Body Replacement System is capable of performing in accordance with its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The subject device is substantially equivalent to the previously cleared Quantum Vertebral Body Replacement.
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
K061576 Quantum Orthopedics, Inc. Special 510(k) – Quantum Vertebral Body Replacement System Page 1 of 2
510(k) Summary Quantum Vertebral Body Replacement System
JUL - 3 2006
| Manufacturer Identification
Submitted by: | Quantum Orthopedics, Inc.
2744 Loker Ave. W., Suite 100
Carlsbad, CA 92010
760-607-0121 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Jason Blain
Chief Technology Officer
Quantum Orthopedics, Inc.
2744 Loker Ave. W., Suite 100
Carlsbad, CA 92010
760-607-0121
jblain@quantumorthopedics.com |
| Date Prepared: | June 6, 2006 |
| Device Identification
Proprietary Name: | Quantum Vertebral Body Replacement System |
| Common Name: | Vertebral Body Replacement |
| Classification Name: | Spinal Vertebral Body Replacement |
Predicate Devices
・
The subject device is substantially equivalent to the previously cleared Quantum Vertebral Body Replacement.
Device Description
The Quantum Vertebral Body Replacement System is composed of a flanged VBR body with screw holes and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry and teeth on its external surfaces. Screws pass through screw holes and affix to bone to help prevent implant migration. The devices are available in a multitude of sizes and are made from titanium and polyetheretherketone (PEEK).
1
Intended Use of the Device
The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
Performance Data
Mechanical testing indicates that the Quantum Vertebral Body Replacement System is capable of performing in accordance with its intended use.
2
Image /page/2/Picture/1 description: The image shows a circular logo with a stylized depiction of a bird in the center. The bird is composed of three curved lines that suggest movement or flight. Surrounding the bird is a circular arrangement of text, although the specific words are not legible due to the image's resolution. The logo appears to be a symbol for an organization or entity, possibly related to aviation, nature, or a government agency.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2006
Quantum Orthopedies. Inc. c.o Mr. Jason Blain. Chief Technology Officer 2744 Loker Ave. W., Suite 100 Carlsbad. CA 92010
Re: K061576
Trade Name: Quantum VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 6, 2006 Received: June 7, 2006
Dear Mr. Blain:
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 - Mr. Blain
Please be advised that FDAs issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not hast 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 lectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 100, 11050. This letter will allow you to begin marketing your device as described in your Scetion 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legal|y marketed predicate device results in a classification for your device and thus, permitts 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 mon ohtain 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/industrv/support/index.html.
Sincerely yours,
Charbang buelirp
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
| 510(k) Number: | K061576 |
|---|---|
| Device Name: | Quantum Vertebral Body Replacement System |
Indications For Use:
The Quantum Vertebral Body Replacement System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sharbare Buchund for MCM
(Division Sign-Off)
Division of Ger and Neurologics
510(k) Number K061576