(44 days)
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No
The document describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a 'Cure™ 2.0 Anterior Cervical Plate (ACP) System' intended for 'anterior screw fixation to the C2 to C7 levels of the cervical spine' for 'temporary stabilization' during spinal fusion in patients with various spinal conditions, indicating a direct therapeutic purpose.
No
The device is an Anterior Cervical Plate System intended for surgical fixation and stabilization of the spine, not for diagnosing conditions. Its purpose is to provide temporary stabilization during spinal fusion, not to identify or characterize diseases.
No
The device description explicitly states it is composed of plates and screws made of titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Cure™ 2.0 Anterior Cervical Plate (ACP) System is for "anterior screw fixation to the C2 to C7 levels of the cervical spine" for "temporary stabilization of the anterior spine during the development of cervical spinal fusion." This describes a surgical implant used directly within the body to provide structural support.
- Device Description: The description details a physical implant made of titanium, consisting of plates and screws. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- 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. This device does not perform any such tests.
The information provided describes a surgical implant used for spinal fusion, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
CureTM 2.0 Anterior Cervical Plate (ACP) 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 radies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Deformity (defined as kyphosis, lordosis), Pseudarthrosis, and Failed previous fusions.
Product codes
KWQ
Device Description
Cure™ 2.0 Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.
Cure™ 2.0 Anterior Cervical Plate (ACP) 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
C2 to C7 levels of the cervical spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Testing according to ASTM F1717 was performed on the Cure™ 2.0 Anterior Cervical Plate (ACP) System to establish equivalency to the predicate device. The tests included static compression bending, static tension, static torsion, dynamic compression bending.
Cure™ 2.0 Anterior Cervical Plate (ACP) System is equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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March 18, 2021
Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Meditech Spine, LLC Bruce Dunaway Chief Design Engineer 1447 Peachtree St NE Suite 440 Atlanta, Georgia 30309
Re: K210286
Trade/Device Name: Cure™ 2.0 Anterior Cervical Plate (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 10, 2021 Received: February 16, 2021
Dear Bruce 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
for
Colin O'Neill, M.B.E. 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) K210286
Device Name Cure™ 2.0 Anterior Cervical Plate (ACP) System
Indications for Use (Describe)
Cure™ 2.0 Anterior Cervical Plate (ACP) 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 radies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Deformity (defined as kyphosis, lordosis), 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) |
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510(k) Summarv
As required by section 807.92(c)
Meditech Spine, LLC is requesting clearance for the Cure™ 2.0 Anterior Cervical Plate (ACP) 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™ 2.0 Anterior Cervical Plate (ACP) System Common Name: Spinal Implant Spinal intervertebral body fixation orthosis (21 CFR 888.3060 Class Classification Name: II,Product Code KWQ)
- C. Predicate Device: K160604 (Cure™ ACP Plate System)
- D. Device Description:
Cure™ 2.0 Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.
Cure™ 2.0 Anterior Cervical Plate (ACP) 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:
Cure™ 2.0 Anterior Cervical Plate (ACP) 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.
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F. Technological Characteristics:
The fundamental technological characteristics of the Cure™ 2.0 ACP is identical to the predicate device. -
G. Non-clinical Testing:
Testing according to ASTM F1717 was performed on the Cure™ 2.0 Anterior Cervical Plate (ACP) System to establish equivalency to the predicate device. The tests included static compression bending, static tension, static torsion, dynamic compression bending.
Cure™ 2.0 Anterior Cervical Plate (ACP) System is equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.
- H. Conclusion:
The completed testing as well as a comparison of the technological characteristics has demonstrated that the Cure™ 2.0 Anterior Cervical Plate (ACP) System is substantially equivalent to the predicate device.