(121 days)
Not Found
No
The summary describes a mechanical implant for spinal support and does not mention any AI/ML components or functions.
Yes
The device is used to replace a damaged vertebral body due to tumor or trauma, providing mechanical support and restoring stability to the spine, which are therapeutic actions.
No
The device is a vertebral body replacement, which is a surgical implant used to provide mechanical support to the spine. It is a treatment device, not a device used to diagnose a medical condition.
No
The device description clearly states it is a system of corpectomy devices with physical components (cylindrical center piece, end caps) used for mechanical support in spinal surgery, indicating it is a hardware device.
Based on the provided information, the Solidity™ Vertebral Body Replacement is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for open surgical procedures in the thoracic and lumbar spine to replace a vertebral body. This is an in vivo application, meaning it is used within the living body.
- Device Description: The description details a system of mechanical components (cylindrical center piece, end caps) designed to provide structural support to the spine. This is a medical device used for surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. The Solidity™ Vertebral Body Replacement is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ is optional.
Product codes
MQP
Device Description
The Solidity™ Vertebral Body Replacement is a system of corpectomy devices used to provide mechanical support to the thoracolumbar spine. The Solidity™ Vertebral Body Replacement components include a cylindrical center piece and end caps. The center piece provides the capability for device expansion. End caps provide the anatomical footprint for the device. The components are offered in expansions, angle, footprint combinations to accommodate varying patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open surgical procedures
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 worst case Solidity™ devices included static and dynamic compression, and static and dynamic torsion according to ASTM F2077. In addition, the expulsion properties were evaluated. The mechanical test results demonstrate that Solidity™ performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K012254, K003155, K171686, K003043, K841189
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.
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November 16, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ulrich medical USA Hans Stover President & CEO 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K181921
Trade/Device Name: Solidity™ Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: September 21, 2018 Received: September 24, 2018
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 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
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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Solidity™ Vertebral Body Replacement
Indications for Use (Describe)
The Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| 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 appear as if it is emerging from a black square. Below the word "Ulrich" is the phrase "medical USA" in a smaller, sans-serif font.
| Date: | 16 July 2018 |
|---|---|
| Sponsor: | ulrich medical USA, Inc. |
| 18221 Edison Avenue | |
| Chesterfield, MO 63005 | |
| (636) 519-0268 Office | |
| (636) 519-0271 Fax | |
| Contact Person: | Hans Stover, President & CEO |
| Proposed Trade Name: | Solidity™ Vertebral Body Replacement |
| Common Name: | Vertebral body replacement |
| Device Classification: | Class II |
| Classification Name: | Spinal vertebral body replacement device |
| Regulation: | 888.3060 |
| Device Product Code: | MQP |
| Device Description: | The Solidity™ Vertebral Body Replacement is a system of corpectomy |
| devices used to provide mechanical support to the thoracolumbar spine. | |
| The Solidity™ Vertebral Body Replacement components include a | |
| cylindrical center piece and end caps. The center piece provides the | |
| capability for device expansion. End caps provide the anatomical footprint | |
| for the device. The components are offered in expansions, angle, footprint | |
| combinations to accommodate varying patient anatomy. | |
| Intended Use: | The Solidity™ Vertebral Body Replacement is intended for use during open |
| surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a | |
| collapsed, damaged, or unstable vertebral body due to tumor or trauma | |
| (e.g., fracture). | |
| The Solidity™ is intended to be used with supplemental spinal fixation. The | |
| use of bone grafting material with the Solidity™ is optional. | |
| Materials: | Solidity™ components are manufactured from Ti-6Al-4V ELI titanium alloy |
| (ASTM F136). | |
| Predicate Devices: | Primary: VBR™ (Osteotech Inc. – K012254) |
| Additional: VBR™ (Osteotech Inc. – K003155), Hawkeye™ VBR System | |
| (Choice Spine LP – K171686), Surgical Titanium Mesh™ System (DePuy | |
| AcroMed, K003043), Rezaian Spinal Fixator (Orthopedic Equipment Co. | |
| Inc. - K841189) | |
| Performance Data: | Mechanical testing of worst case Solidity™ devices included static and |
| dynamic compression, and static and dynamic torsion according to ASTM | |
| F2077. In addition, the expulsion properties were evaluated. | |
| The mechanical test results demonstrate that Solidity™ performance is | |
| substantially equivalent to the predicate devices. | |
| Technological | |
| Characteristics: | The Solidity™ Vertebral Body Replacement 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 Solidity™ is the same as previously cleared devices. | |
| Conclusion: | The Solidity™ Vertebral Body Replacement possesses the same intended use and technological characteristics as the predicate devices. Therefore Solidity™ is substantially equivalent for its intended use. |
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