(101 days)
No
The summary describes a mechanical implant (lumbar plate system) and its intended use and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is a temporary fixation system used in spinal surgery to treat various conditions like fractures, tumors, and degenerative disc disease, indicating its direct therapeutic application to a patient's medical condition.
No
The device is a temporary fixation device used in spine surgery, not for diagnosing conditions.
No
The device description explicitly states that the device is a "Lumbar Plate System" manufactured from Grade 23 Titanium, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (a lumbar plate system) made of titanium, intended for temporary fixation of the spine during surgical procedures.
- Intended Use: The intended use clearly states it's for treating spine instability through surgical approaches, not for analyzing biological samples.
The device is a surgical implant/device, not an IVD.
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
KWO
Device Description
The Cure™ Lumbar Plates (Cure™ - LP IView and Cure™ - QMax ) are available in a range of sizes to coincide with the surgical approach. The Cure™ - LP IView is identical to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole and the inclusion of a central rib at the through hole location. The Cure™ - LP QMax is identical to the Cure™ Lateral Lumbar plate with the exceptions of plate width and number of screw holes allocations. All Cure™ Lumbar Plates are 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, thoracic and thoracolumbar (T1-L5) spine, lumbar and 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
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Summary of Performance Studies
An engineering analysis was performed on the previously cleared Cure™ Lumbar Plate System. The analysis included static compression bending, static torsion, static torsion, and dynamic compression bending.
Cure™ - LP IView and Cure™ - LP QMax Lumbar Plates are superior in mechanical function and properties to the predicate device.
Key Metrics
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 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 features a stylized depiction of a human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
April 23, 2018
Meditech Spine, LLC Bruce Dunaway Chief Design Engineer 1447 Peachtree Street NE Suite 440 Atlanta, Georgia 30309
Re: K180090
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: KWO Dated: March 29, 2018 Received: March 30, 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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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Indications for Use
510(k) Number (if known) K180090
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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meditech sp
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
510(k) Summarv
April 17, 2018
As required by section 807.92(c)
Meditech Spine, LLC is requesting marketing clearance for the Cure™ 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 Classification Name: Spinal intervertebral body fixation orthosis (21 CFR 888.3060 Class II,Product Code KWQ)
- K171538 ( Cure™ Lumbar Plate System) C. Predicate Device:
- D. Device Description:
The Cure™ Lumbar Plates (Cure™ - LP IView and Cure™ - QMax ) are available in a range of sizes to coincide with the surgical approach. The Cure™ - LP IView is identical to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole and the inclusion of a central rib at the through hole location. The Cure™ - LP QMax is identical to the Cure™ Lateral Lumbar plate with the exceptions of plate width and number of screw holes allocations. All Cure™ Lumbar Plates are 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 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.
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meditech spine, IIc
1447 Peachtree St NE Suite 440, Atlanta GA 30309 | p (678) 974-5287 | f (404) 759-2104 | support@meditechspine.com
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F. Technological Characteristics:
The fundamental technological characteristics of the Cure™ - LP IView and Cure™ - LP QMax are identical to the predicate device. -
G. Non-clinical Testing:
An engineering analysis was performed on the previously cleared Cure™ Lumbar Plate System. The analysis included static compression bending, static torsion, static torsion, and dynamic compression bending.
Cure™ - LP IView and Cure™ - LP QMax 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™ - LP IView and Cure™ - LP QMax Lumbar Plate allows that both are substantially equivalent to the predicate device.