(153 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal plate system, with no mention of AI or ML capabilities.
Yes
The device is described as an internal fixation device for spinal surgery intended for various conditions like fracture, tumor, degenerative disc disease, and spinal deformities, and functions to stabilize the spine and aid in fusion, which aligns with the definition of a therapeutic device.
No
The device is an internal fixation device intended for surgical use to provide temporary fixation and aid in spinal fusion. It does not perform any diagnostic functions.
No
The device description explicitly states that the system consists of spinal plates and bone screws, which are physical hardware components made of Titanium alloy. The performance studies also focus on the mechanical properties of these hardware components.
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 in skeletally mature patients with various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as an internal fixation device consisting of plates and screws made of titanium alloy. This is consistent with a surgical implant.
- No mention of in vitro testing: The description and performance studies focus on mechanical testing of the implant itself (static and dynamic bending, torsion, etc.) and its equivalence to predicate devices. There is no mention of analyzing samples from the human body (blood, tissue, etc.) to provide diagnostic information.
- No mention of diagnostic purpose: The device is intended to provide temporary fixation and aid in spinal fusion, not to diagnose a condition.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Curiteva Thoracolumbar Plate System Two Hole and Four Hole Plates are 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 greatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients 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 is achieved.
The Curiteva Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-SI ) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Product codes
KWQ
Device Description
The Curiteva Thoracolumbar Plate System is an internal fixation device for spinal surgery that consists of various configurations of spinal plates and bone screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. All system implants are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and thoracolumbar (T1-L5) spine, lumbar and lumbosacral (L1-S1) 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)
Non-clinical testing performed on the Curiteva Thoracolumbar Plate System supports substantial equivalence to predicate devices. The following testing was performed:
- Static compression bending per ASTM F1717
- Dynamic compression bending per ASTM F1717
- Static torsion per ASATM F1717
- Static cantilever bending per ASTM F2193
- Dynamic cantilever bending per ASTM F2193
The results of non-clinical testing demonstrate that the strength and performance of the Curiteva Thoracolumbar Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K171538 / K180090, K142699, K173885, K181063
Reference Device(s)
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.
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February 29, 2024
Image /page/0/Picture/1 description: The image contains 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 words "U.S. Food & Drug Administration" in blue text.
Curiteva, Inc. Eric Linder Chief Technology Officer 25127 Will McComb Drive Suite 100 Tanner, Alabama 35671
Re: K233360
Trade/Device Name: Curiteva Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 29, 2023 Received: September 29, 2023
Dear Eric Linder:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2024.02.29
15:01:00-05'00'
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
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Indications for Use
510(k) Number (if known)
K233360
Device Name Curiteva Thoracolumbar Plate System
Indications for Use (Describe)
The Curiteva Thoracolumbar Plate System Two Hole and Four Hole Plates are 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 greatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients 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 is achieved.
The Curiteva Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-SI ) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
| 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/0 description: The image shows the logo for Curiteva. The logo consists of a stylized hexagon shape made up of smaller hexagons, most of which are dark blue, but one is light blue. Below the shape is the word "CURITEVA" in a sans-serif font, with a trademark symbol next to it.
510(k) Summary
A. Submitter Information
| Submitter: | Curiteva, Inc.
25127 Will McComb Drive
Tanner, AL 35671
Phone: (256) 213-1057
Fax: (256) 213-1058 |
|-----------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eric Linder
regulatory@curiteva.com |
| Date Prepared: | February 29, 2024 |
B. Device Information
| Trade Name: | Curiteva Thoracolumbar Plate System |
|---|---|
| Common Name: | Spinal Fixation System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Classification: | Class II (per 21 CFR 888.3060) |
| Product Code: | KWQ |
| Predicate Device(s): | Primary: Meditech Spine Cure Lumbar Plate System (K171538 |
| / K180090) | |
| Additional: Stryker LITe Plate System (K142699) | |
| Additional: Genesys Spine Binary Lumbar Plate System | |
| (K173885) | |
| Additional: Innovasis Kestrel Buttress Plate System (K181063) |
C. Device Description
The Curiteva Thoracolumbar Plate System is an internal fixation device for spinal surgery that consists of various configurations of spinal plates and bone screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. All system implants are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
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D. Indications for Use
The Curiteva Thoracolumbar Plate System Two Hole Plates are 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 in skeletally mature patients 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, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
The Curiteva Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
E. Technological Characteristics
As was established in this submission, the subject Curiteva Thoracolumbar Plate System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and to have similar technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and range of sizes.
F. Performance Data
Non-clinical testing performed on the Curiteva Thoracolumbar Plate System supports substantial equivalence to predicate devices. The following testing was performed:
- Static compression bending per ASTM F1717
- Dynamic compression bending per ASTM F1717
- Static torsion per ASATM F1717
- Static cantilever bending per ASTM F2193
- Dynamic cantilever bending per ASTM F2193
The results of non-clinical testing demonstrate that the strength and performance of the Curiteva Thoracolumbar Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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G. Conclusion
Based on the indications for use, technological characteristics, non-clinical performance testing, and comparison to predicate devices, the subject Curiteva Thoracolumbar Plate System has been shown to be substantially equivalent to legally marketed predicate devices.