(14 days)
Not Found
No
The summary describes a mechanical implant (lumbar plate) and its material properties and mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a temporary fixation device for spinal instability that helps achieve fusion, which is a therapeutic outcome for various spinal conditions like fractures, tumors, and degenerative disc disease.
No
This device is described as a "temporary fixation device" for spine instability, indicating its role in treatment rather than diagnosis.
No
The device description explicitly states it is a "Lumbar Plate" manufactured from Grade 23 Titanium, which is a physical hardware implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a metal plate made of titanium, designed for surgical implantation. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Cure™ Lumbar Plate (Cure™ OPEL-L (S)) is available in a range of sizes to coincide with the surgical approach. The Cure™ OPEL-L (S) is similar to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole, the inclusion of a central rib at the through hole location and convexity in the sagittal plane at the screw hole locations.
All Cure™ Lumbar Plates continue to be 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
thoracolumbar (T1-L5) spine, lumbosacral (L1-S1) spine
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)
An engineering analysis was performed on the Cure™ OPEL-L (S) to demonstrate equivalency to the previously tested predicate device (Cure™ Anterior Lumbar Plate System) with respect to static compression bending, static tension, and dynamic compression bending per ASTM F1717.
Cure™ OPEL-L (S) Lumbar Plates are superior in mechanical function and properties to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
May 12, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Meditech Spine, LLC Mr. Bruce Dunaway Chief Design Engineer 1447 Peachtree St NE Suite 440 Atlanta, Georgia 30309
Re: K201136
Trade/Device Name: Cure™ Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 27, 2020 Received: April 28, 2020
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/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,
Colin O'Neill, M.B.E. Acting 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
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Indications for Use
510(k) Number (if known) K201136
Device Name Cure™ Lumbar Plate System
Indications for Use (Describe)
The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
| 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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Image /page/3/Picture/1 description: The image shows a logo with a stylized letter "M". The logo is composed of two rounded rectangles and a circle. The first rectangle is oriented vertically, and the second rectangle is oriented horizontally. The circle is located to the right of the rectangles. The logo is colored in shades of blue, with the vertical rectangle being a lighter shade of blue and the horizontal rectangle and circle being a darker shade of blue.
510(k) Summary
As required by section 807.92(c)
Meditech Spine, LLC is requesting marketing clearance for the Cure™ OPEL-L (S) Lumbar Plate 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™ Lumbar Plate System Common Name: Spinal Implant Spinal intervertebral body fixation orthosis (21 CFR 888.3060 Class Classification Name: II,Product Code KWQ)
- C. Predicate Device: K171538 (Cure™ Lumbar Plate System)
- D. Device Description:
The Cure™ Lumbar Plate (Cure™ OPEL-L (S)) is available in a range of sizes to coincide with the surgical approach. The Cure™ OPEL-L (S) is similar to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole, the inclusion of a central rib at the through hole location and convexity in the sagittal plane at the screw hole locations.
All Cure™ Lumbar Plates continue to be 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™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine
4
Image /page/4/Picture/1 description: The image shows a logo with a stylized letter "M" and a circle. The "M" is formed by two rounded rectangles that overlap each other. The left rectangle is a lighter shade of blue, while the right rectangle and the circle are a darker shade of blue. The circle is positioned to the right of the "M".
instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
- F. Technological Characteristics:
The fundamental technological characteristics of the Cure™ OPEL-L (S) is identical to the predicate device.
G. Non-clinical Testing:
An engineering analysis was performed on the Cure™ OPEL-L (S) to demonstrate equivalency to the previously tested predicate device (Cure™ Anterior Lumbar Plate System) with respect to static compression bending, static tension, and dynamic compression bending per ASTM F1717.
Cure™ OPEL-L (S) Lumbar Plates are superior in mechanical function and properties to the predicate device.
- H. Conclusion:
The identical intended use and consistency between the fundamental scientific technology between the Cure™ OPEL-L (S) Lumbar Plate allows that it is substantially equivalent to the predicate device.