(271 days)
Not Found
No
The provided 510(k) summary describes a mechanical implant for spinal surgery and does not mention any AI or ML components or functionalities.
Yes
The device is described as a vertebral body replacement system used to treat diseased or damaged vertebral bodies and reconstruct the spinal column, which are therapeutic interventions.
No
This device is a surgical implant designed to replace diseased or damaged vertebral bodies and restore spinal stability, not to diagnose medical conditions.
No
The device description clearly states it is an adjustable vertebral body replacement device made of 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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The MediExpand Cervical Expandable VBR System is a physical implant designed to replace a diseased or damaged vertebral body in the cervical spine. It is surgically implanted into the body.
- Lack of Diagnostic Function: The device's purpose is structural support and reconstruction, not the analysis of biological samples for diagnostic purposes.
Therefore, the MediExpand Cervical Expandable VBR System falls under the category of a medical device, specifically a surgical implant, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MediExpand Cervical Expandable VBR System is intended for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Use of the MediExpand Cervical Expandable VBR System is limited to single-level or two-level corpectomy and the device is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The MediExpand Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes
PLR
Device Description
The MediExpand Cervical 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 devices can be adjusted to the required height after implantation. Once it is adjusted to the desired height the device is mechanically locked in place with fixation screws. The devices have a rectangular 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 anqles. The devices have threaded holes for anchor screws which can be inserted into the adjacent vertebral bodies. 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
cervical spine (C3-C7 vertebral bodies)
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)
Static and dynamic testing of the MediExpand Cervical Expandable VBR System was performed in accordance with ASTM F2077.
Clinical data from Europe have shown the clinical performance and support the use of the MediExpand Cervical Expandable VBR System as treatment of turnors, trauma, and degenerative disorders of the cervical spine.
Real World Data (RWD) is presented from three sites in Germany. The clinical data includes results from 338 patients were the MediExpand Cervical Expandable VBR was implanted for vertebral bodv replacement:
- 40 cases from University Hospital of Ludwig-Maximilians-University (LMU) in Munich
- 258 cases from Central Clinic in Bad Berka
- 40 cases from Schoen Clinic Hamburg Eilbek, Hamburg
This data has been analyzed retrospectively in support of substantial equivalence of the device under 510(k) review. There were no instances of implant failure, and none of the patients suffered from implant associated damages/injuries. The results demonstrate that the subject MediExpand Cervical Expandable VBR System is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nuvasive X-Core Mini Cervical Expandable VBR System (K151651), Aesculap Modulift Vertebral Body Replacement (VBR) System (K172032)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 4, 2022
CMF Medicon Surgical Inc. Mr. Matthias Alber Executive Vice President 11200 St. Johns Industrial Pkwy N. Suite 1 Jacksonville, Florida 32246
Re: K212126
Trade/Device Name: MediExpand Cervical Expandable VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR Dated: February 28, 2022 Received: March 3, 2022
Dear Mr. Alber:
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
1
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,
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212126
Device Name
MediExpand Cervical Expandable VBR System
Indications for Use (Describe)
The MediExpand Cervical Expandable VBR System is intended for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vy tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Use of the MediExpand Cervical Expandable VBR System is limited to single-level or two-level corpectomy and the device is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The MediExpandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
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
Executive Vice President |
| Contact Person and Telephone: | Matthias Alber
904-642-7500 |
| Date Summary Prepared: | 03/31/2022 |
| Device Name: | Classification Name – Spinal Intervertebral Body Fixation
Orthosis
Common or Usual Name - Spinal Vertebral Body
Replacement Device
Proprietary Name – MediExpand Cervical Expandable
VBR System |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3060 |
| Product Code: | PLR |
| Predicate Devices
Primary Predicate Device: | Nuvasive X-Core Mini Cervical Expandable VBR System
(K151651) |
| Additional Predicate Device: | Aesculap Modulift Vertebral Body Replacement (VBR)
System (K172032) |
Device Description:
The MediExpand Cervical 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 devices can be adjusted to the required height after implantation. Once it is adjusted to the desired height the device is mechanically locked in place with fixation screws. The devices have a rectangular 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 anqles. The devices have threaded holes for anchor screws which can be inserted into the adjacent vertebral bodies. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.
4
Indication for Use:
The MediExpand Cervical Expandable VBR System is intended for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Use of the MediExpand Cervical Expandable VBR System is limited to single-level or two-level corpectomy and the device is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The MediExpand Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Technological Characteristics:
As was established in this submission, the subject MediExpand Cervical 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 clinical data and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, performance, material composition, and function.
The MediExpand Cervical Expandable VBR System and the predicate devices Nuvasive X-Core Mini Cervical Expandable VBR System and Aesculap Modulift Vertebral Body Replacement (VBR) System are similar in design, material, and indicated use, and are both cleared devices.
Performance Testing:
Static and dynamic testing of the MediExpand Cervical Expandable VBR System was performed in accordance with ASTM F2077.
Clinical data from Europe have shown the clinical performance and support the use of the MediExpand Cervical Expandable VBR System as treatment of turnors, trauma, and degenerative disorders of the cervical spine.
Real World Data (RWD) is presented from three sites in Germany. The clinical data includes results from 338 patients were the MediExpand Cervical Expandable VBR was implanted for vertebral bodv replacement:
- 40 cases from University Hospital of Ludwig-Maximilians-University (LMU) in Munich
- 258 cases from Central Clinic in Bad Berka
- 40 cases from Schoen Clinic Hamburg Eilbek, Hamburg
This data has been analyzed retrospectively in support of substantial equivalence of the device under 510(k) review. There were no instances of implant failure, and none of the patients suffered from implant associated damages/injuries. The results demonstrate that the subject MediExpand Cervical Expandable VBR System is substantially equivalent to predicate devices.
Conclusion:
Based on the indication for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject MediExpand Cervical Expandable VBR System has been shown to be substantially equivalent to the legally marketed predicate devices.