(80 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusion, which is a therapeutic purpose.
No
Explanation: The device description states it is a system for anterior screw fixation and temporary stabilization during spinal fusion, not for diagnosing conditions.
No
The device description explicitly states it is a plate system manufactured from Grade 23 Titanium, indicating it is a physical implant, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (an anterior screw fixation system) intended for use within the body to stabilize the cervical spine. It does not involve testing samples taken from the body.
The device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cure™ OPEL-C System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.
Product codes
KWQ
Device Description
The Cure™ OPEL-C (T) and Cure™ OPEL-C (S) are available in a range of lengths to coincide with the surgical approach and screws that are available in multiple lengths and diameters.
The Cure™ OPEL-C Plate System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to C7 levels of the cervical 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)
An engineering analysis was performed on the Cure™ OPEL-C (T) and (S) to demonstrate equivalency to the previously tested predicate device with respect to static compression bending, static tension, and dynamic compression bending per ASTM F1717.
Cure™ OPEL-C (T) and (S) Anterior Cervical Plates are superior in mechanical function to the 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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 31, 2018
Meditech Spine, LLC Mr. Bruce Dunaway Chief Design Engineer 1447 Peachtree Sreet NE. Suite 440 Atlanta, Georgia 30309
Re: K181543
Trade/Device Name: Cure™ OPEL-C Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 20, 2018 Received: July 20, 2018
Dear Mr. Dunaway:
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/cdrl/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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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,
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181543
Device Name Cure™ OPEL-C Plate System
Indications for Use (Describe)
The Cure™ OPEL-C System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.
| 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
Meditech Spine, LLC is requesting marketing clearance for the Cure™ OPEL-C System
| A. | Sponsor/Manufacturer: | Meditech Spine, LLC |
|---|---|---|
| Registration Number: 3009405289 | ||
| Bruce Dunaway, Chief Design Engineer | ||
| 1447 Peachtree St NE Suite 440 | ||
| Atlanta, GA 30309 | ||
| 678-974-5287 Phone | ||
| 404-759-2104 Fax |
- B. Trade Name: Cure™ OPEL-C Plate System Common Name: Spinal Implant Classification Name: Spinal intervertebral body fixation orthosis (21 CFR 888.3060 Class II,Product Code KWQ)
- ﻥ Predicate Device: K160604 (Cure™ Anterior Cervical Plate System)
- D. Device Description:
The Cure™ OPEL-C (T) and Cure™ OPEL-C (S) are available in a range of lengths to coincide with the surgical approach and screws that are available in multiple lengths and diameters.
The Cure™ OPEL-C Plate System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
-
E. Indications for Use:
The Cure™ OPEL-C System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Deformity (defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions. -
F. Technological Characteristics:
The Cure™ OPEL-C (T) and (S) are similar geometrically to the predicate device (thickness, size envelope). The central locking mechanism of the Cure™ OPEL-C (T) and (S) used to prohibit bone screw back out is identical to that of the predicate device. Additionally, the bone screws and supporting instrumentation utilized are identical to those of the predicate device.
4
Differences between the Cure™ OPEL-C (T) and (S) and the predicate device exist exclusively on the posterior side of the subject devices. An offset shelf and a pair of 2mm posts appropriately sized to interface with Talos® -C interbodies have been implemented on the Cure™ OPEL-C (T) and (S) to facilitate ideal alignment during an ACDF. Additionally there is an absence of graft windows, an increase in maximum screw angulation (27°) and a decrease in axial radius (20mm) on the subject devices.
The fundamental technological characteristics of the Cure™ OPEL-C (T) and (S) are identical to the predicate device.
G. Non-clinical Testing:
An engineering analysis was performed on the Cure™ OPEL-C (T) and (S) to demonstrate equivalency to the previously tested predicate device with respect to static compression bending, static tension, and dynamic compression bending per ASTM F1717.
Cure™ OPEL-C (T) and (S) Anterior Cervical Plates are superior in mechanical function to the predicate device.
H. Conclusion:
The identical intended use and consistency between the fundamental scientific technology between the Cure™ OPEL-C (T) and Cure™ OPEL-C (S) allows that both are substantially equivalent to the predicate device.