(87 days)
Not Found
No
The summary describes a mechanical implant for spinal support and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as replacing a collapsed or unstable vertebral body due to various conditions (tumor, osteomyelitis, trauma, degenerative disorders) and restoring the integrity of the spinal column. These actions are for treating or managing a medical condition, which aligns with the definition of a therapeutic device.
No
The device is a vertebral body replacement (VBR) implant designed to provide mechanical support to the spine, restore spinal integrity, and replace collapsed or unstable vertebral bodies. Its function is to provide structural support, not to diagnose a condition.
No
The device description clearly states it is a "system of corpectomy devices" and a "cylindrical implant," indicating it is a physical hardware device intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Small VBR is a surgical implant used to replace or support vertebral bodies in the spine. It is a mechanical device intended for direct implantation into the body.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. Its purpose is structural support and reconstruction.
Therefore, the Small VBR falls under the category of a medical device (specifically, a surgical implant), not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Small VBR is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Small VBR is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Small VBR is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Small VBR is optional.
Product codes
MOP, PLR
Device Description
Small VBRTM is a system of corpectomy devices used to provide mechanical support to the cervical and thoracolumbar spine. Small VBRTM is a cylindrical implant with the capability for device expansion. The ends of the device incorporate a ring of teeth to engage the endplates of adjacent vertebrae. The device is offered non-sterile in various combinations of expansion range, angulation and footprint to accommodate patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1), thoracolumbar spine (T1-L5), cervical, thoracic, and lumbar spine
Indicated Patient Age Range
skeletally mature patients
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 of the worst case Small VBRTM devices included static and dynamic compression and static and dynamic torsion following ASTM F2077.
The mechanical test results demonstrate that Small VBRTM device performance is substantially equivalent to itself as a predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
November 1, 2019
ulrich GmbH & Co. KG % Mr. Hans Stover President & CEO ulrich medical USA 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K192117
Trade/Device Name: Small VBRTM Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MOP, PLR Dated: August 5, 2019 Received: August 6, 2019
Dear Mr. Stover:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192117
Device Name Small VBR™
Indications for Use (Describe)
The Small VBR is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Small VBR is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Small VBR is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Small VBR is optional.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Image /page/3/Picture/2 description: The image shows the logo for Ulrich Medical USA. The logo consists of the word "Ulrich" in a bold, sans-serif font, with the "U" stylized to include a black square to its left. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font.
| Date: | 5 August 2019 |
|---|---|
| Sponsor: | ulrich GmbH & Co. KG |
| Buchbrunnenweg 12 | |
| 89081 Ulm | |
| Germany | |
| Phone: +49 (0) 731-9654-1304 | |
| Fax: +49 (0) 731-9654-2802 | |
| Contact Person: | Hans Stover |
| ulrich medical USA, Inc. | |
| 18221 Edison Avenue | |
| Chesterfield, MO 63005 | |
| (636) 519-0268 Office | |
| (636) 519-0271 Fax | |
| Proposed Trade Name: | Small VBR™ |
| Common Name: | Vertebral body replacement |
| Device Classification: | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation: | 21 CFR 888.3060 |
| Device Product Code: | MQP, PLR |
| Purpose: | The aim of this submission is to request additional cervical spine indications |
| for the Small VBR™. | |
| Device Description: | Small VBR™ is a system of corpectomy devices used to provide mechanical |
| support to the cervical and thoracolumbar spine. Small VBR™ is a cylindrical | |
| implant with the capability for device expansion. The ends of the device | |
| incorporate a ring of teeth to engage the endplates of adjacent vertebrae. | |
| The device is offered non-sterile in various combinations of expansion | |
| range, angulation and footprint to accommodate patient anatomy. | |
| Intended Use: | The Small VBR is intended for use in skeletally mature patients in the |
| cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a | |
| collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, | |
| trauma (i.e. fracture), or for reconstruction following corpectomy performed | |
| to achieve decompression of the spinal cord and neural tissues in | |
| degenerative disorders. | |
| The Small VBR is also intended to restore the integrity of the spinal column | |
| even in the absence of fusion for a limited time period in patients with | |
| advanced stage tumors involving the cervical, thoracic, and lumbar spine in | |
| whom life expectancy is of insufficient duration to permit achievement of | |
| fusion, with bone graft used at the surgeon's discretion. | |
| The Small VBR is intended to be used with supplemental spinal fixation | |
| systems cleared for use in the cervical, thoracic, and/or lumbar spine. The | |
| use of bone grafting material with the Small VBR is optional. | |
| Materials: | Small VBR™ implants are manufactured from Ti-6Al-4V ELI titanium alloy |
| (per ASTM F136). |
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| Primary Predicate: | Fortify® (Globus Medical Inc. – K173982) |
|---|---|
| Additional Predicates: | VBRTM (Osteotech Inc. – K012254), Rezaian Spinal Fixator (Orthopedic |
| Equipment Co. Inc. - K841189) | |
| Performance Data: | Mechanical testing of the worst case Small VBRTM devices included static |
| and dynamic compression and static and dynamic torsion following ASTM | |
| F2077. | |
| The mechanical test results demonstrate that Small VBRTM device | |
| performance is substantially equivalent to itself as a predicate device. | |
| Technological | |
| Characteristics: | The Small VBRTM possesses the same technological characteristics as one |
| or more of the predicate devices. These include: | |
| basic design (expanding corpectomy spacer), material (titanium alloy), sizes (dimensions are comparable to those offered by the predicate systems) and | |
| The fundamental scientific technology of the Small VBRTM is the same as | |
| previously cleared devices. | |
| Conclusion: | The Small VBRTM possesses the same intended use and technological |
| characteristics as the predicate devices. Therefore Small VBRTM is | |
| substantially equivalent for its intended use. |