(54 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "spinal fixation system" used as an "adjunct to fusion" for various medical conditions like "degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis, pseudarthrosis and/or failed previous fusion." These indications clearly demonstrate its role in treating or managing a disease or condition, which aligns with the definition of a therapeutic device.
No
The device description indicates it is a surgical implant system ("fixation system for spinal surgery that consists of a variety of screws, rods, set screws, crosslink connectors, rod connectors, and hooks") used for treatment, not for diagnosis.
No
The device description explicitly states that the Curiteva Pedicle Screw System consists of physical implants made from Titanium alloy and Cobalt Chromium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Curiteva Pedicle Screw System is a surgical implant system consisting of screws, rods, and other components used for spinal fixation. It is a physical device implanted into the body.
- Intended Use: The intended use describes the surgical procedure and the conditions it is used to treat (degenerative disc disease, spondylolisthesis, trauma, etc.). It does not involve testing bodily samples.
The information provided clearly describes a surgical implant system, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Curiteva Pedicle Screw System is intended for posterior, non-cervical pedicle screw fixation (T1-S2/ilium) and hook fixation (T1-L5) in skeletally mature patients as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor, stenosis, pseudarthrosis and/or failed previous fusion. The Curiteva Pedicle Screw System is intended to be used with autograft and/or allograft.
Product codes
NKB, KWP
Device Description
The Curiteva Pedicle Screw System is a thoracolumbar and/or sacral spine fixation system for spinal surgery that consists of a variety of screws, rods, set screws, crosslink connectors, rod connectors, and hooks. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy.
The Curiteva Pedicle Screw System implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Select rods are also available in medical grade Cobalt Chromium alloy (per ASTM F1537). All implants are intended for single use only and should not be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical pedicle screw fixation (T1-S2/ilium) and hook fixation (T1-L5)
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)
The Curiteva Pedicle Screw System was mechanically tested in the following test modes: static and dynamic axial compression bend per ASTM F1717 and static torsion per ASTM F1717.
The results of this non-clinical testing show that the strength and performance of the Curiteva Pedicle Screw 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)
Zimmer Spine Vitality Spinal Fixation System - K150896, Clariance Spine Erisma LP MIS - K162367
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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August 28, 2019
Curiteva, Inc. Eric Linder Chief Technology Officer 25127 Will McComb Drive Tanner, Alabama 35671
Re: K191810
Trade/Device Name: Curiteva Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: July 3, 2019 Received: July 5, 2019
Dear Mr. 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 (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/cfpmr/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
1
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 (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 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
Ronald P. Jean, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K191810
Device Name Curiteva Pedicle Screw System
Indications for Use (Describe)
The Curiteva Pedicle Screw System is intended for posterior, non-cervical pedicle screw fixation (T1-S2/ilium) and hook fixation (T1-L5) in skeletally mature patients as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor, stenosis, pseudarthrosis and/or failed previous fusion. The Curiteva Pedicle Screw System is intended to be used with autograft and/or allograft.
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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K191810 page 1 of 2
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: | August 27, 2019 |
B. Device Information
| Trade Name: | Curiteva Pedicle Screw System |
|---|---|
| Common Name: | Pedicle Screw System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Device Classification: | Class II (per 21 CFR 888.3070) |
| Product Code(s): | NKB, KWP |
| Classification Panel: | Division of Orthopedic Devices |
| Predicate Device(s): | Zimmer Spine Vitality Spinal Fixation System - K150896 |
| Additional predicate: | Clariance Spine Erisma LP MIS - K162367 |
C. Device Description
The Curiteva Pedicle Screw System is a thoracolumbar and/or sacral spine fixation system for spinal surgery that consists of a variety of screws, rods, set screws, crosslink connectors, rod connectors, and hooks. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy.
The Curiteva Pedicle Screw System implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Select rods are also available in medical grade Cobalt Chromium alloy (per ASTM F1537). All implants are intended for single use only and should not be reused under any circumstances.
4
D. Indications for Use
The Curiteva Pedicle Screw System is intended for posterior, non-cervical pedicle screw fixation (T1-S2/ilium) and hook fixation (T1-L5) in skeletally mature patients as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor, stenosis, pseudarthrosis and/or failed previous fusion. The Curiteva Pedicle Screw System is intended to be used with autograft and/or allograft.
E. Technological Characteristics
As was established in this subject Curiteva Pedicle Screw 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 the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.
F. Performance Data
The Curiteva Pedicle Screw System was mechanically tested in the following test modes: static and dynamic axial compression bend per ASTM F1717 and static torsion per ASTM F1717.
The results of this non-clinical testing show that the strength and performance of the Curiteva Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
G. Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Curiteva Pedicle Screw System has been shown to be substantially equivalent to legally marketed predicate devices.