(252 days)
Not Found
No
The description focuses on the mechanical aspects of the device (expandable columns, footplates, materials) and mentions standard performance testing (ASTM F2077). There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is used to replace a diseased or damaged vertebral body, restore height, and decompress the spinal cord, all of which are actions intended to treat a medical condition.
No
The device description indicates it is an adjustable vertebral body replacement device, which is an implant used for structural support, not for diagnosing conditions.
No
The device description clearly states it is an "adjustable vertebral body replacement device" manufactured from titanium alloy, which is a physical implant, not software.
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: The MediExpand TL Expandable VBR System is a physical implant designed to replace a vertebral body in the spine. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use clearly states it is for replacing a diseased or damaged vertebral body and restoring spinal height and decompression. This is a therapeutic/surgical intervention, not a diagnostic one.
Therefore, the MediExpand TL Expandable VBR System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MediExpand TL Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore the height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neutral tissues. The MediExpand TL Expandable VBR System is intended to be used with supplemental internal spinal fixations systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.
Product codes
MQP
Device Description
The MediExpand TL Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The columns can of the device can be adjusted to the exact length required by the patient's anatomy after implantation. Once it is adjusted to the desired length the columns are mechanically locked in place. The devices have a cylindrical space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to 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)
Static and dynamic testing of the MediExpand TL Expandable VBR System was performed in accordance with ASTM F2077 as recommended by the FDA Guidance for Spinal System 510(k)'s.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
October 24, 2019
CMF Medicon Surgical Inc. % David Klementowski Sr. Consultant Regulatory Compliance Associates 102 Finwood Dr. Baldwinsville, New York 13027
Re: K190349
Trade/Device Name: MediExpand TL Expandable VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: September 17, 2019 Received: September 19, 2019
Dear Mr. Klementowski:
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
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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 (OS) 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 mediation-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,
Katherine D. Kavlock -S
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)
Device Name
MediExpand TL Expandable VBR System
Indications for Use (Describe)
The MediExpand TL Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore the height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neutral tissues. The MediExpand TL Expandable VBR System is intended to be used with supplemental internal spinal fixations systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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In accordance with Title 21 of the Code of the Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
| Submitter's Name and Address: | CMF MEDICON SURGICAL INC
11200 St. Johns Industrial Pkwy N. Suite 1
Jacksonville, FL 32246
USA |
|-------------------------------|---------------------------------------------------------------------------------------------------------|
| Official Contact: | Matthias Alber |
| Contact Person and Telephone: | David Klementowski
315-345-9514 |
| Date Summary Prepared: | 12/20/2018 |
| Device Name: | Classification Name – Spinal Intervertebral
Body Fixation Orthosis |
| | Common or Usual Name - Spinal Vertebral
Body Replacement Device |
| | Proprietary Name – MediExpand TL
Expandable VBR System |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3060 |
| Product Code: | MQP |
| Predicate Devices | |
| Primary Predicate Device: | Nuvasive X-Core Expandable VBR System
(K142205) |
| Additional Predicate Device: | Aesculap HydroLift VBR System (K083186) |
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Device Description:
The MediExpand TL Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The columns can of the device can be adjusted to the exact length required by the patient's anatomy after implantation. Once it is adjusted to the desired length the columns are mechanically locked in place. The devices have a cylindrical space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.
Indication for Use:
The MediExpand TL Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore the height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neutral tissues. The MediExpand TL Expandable VBR System is intended to be used with supplemental internal spinal fixations systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Technological Characteristics:
As was established in this submission, the subject MediExpand TL Expandable VBR System is substantially equivalent to the other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent based on having the same technological characteristics to its predicate devices through comparison in areas including design, intended use, performance, material composition, and function.
Performance Testing:
The MediExpand TL Expandable VBR System and the predicate devices Nuvasive X-Core Expandable VBR System and Aesculap HydroLift VBR System are similar in design, material, and indicated use, and are both cleared devices.
Static and dynamic testing of the MediExpand TL Expandable VBR System was performed in accordance with ASTM F2077 as recommended by the FDA Guidance for Spinal System 510(k)'s.
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Conclusion:
Based on the indication for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject MediExpand TL Expandable VBR System has been shown to be substantially equivalent to the legally marketed predicate devices.