(643 days)
Not Found
No
The device description focuses on mechanical components for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is intended to provide additional support during fusion for various spinal instabilities or deformities, which is a therapeutic purpose.
No
The ARTFX SPINAL FIXATION SYSTEM is described as a surgical implant designed to provide support and promote spinal fusion for various spinal conditions, not to diagnose them.
No
The device description explicitly lists physical components like screws, rods, connectors, and hooks, and mentions fabrication from titanium alloy. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ARTFX SPINAL FIXATION SYSTEM is for providing "additional support during fusion using autograft in skeletally mature patients in the treatment of... acute and chronic instabilities or deformities" of the noncervical spine. This describes a surgical implant used in vivo (within the body) to stabilize the spine.
- Device Description: The description details a system of physical components (screws, rods, connectors, hooks, setscrews) made of titanium alloy. These are physical implants, not reagents or instruments used to test biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The ARTFX SPINAL FIXATION SYSTEM is a surgical implant used to physically stabilize the spine.
N/A
Intended Use / Indications for Use
ARTFX SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as an anterior anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
-Degenerative dise disease (DDD) (defined as back pain of discogenic origin with degeneration of the dise confirmed by history and radiographic studies): .
-Spondylolisthesis;
-
Trauma (i.e. fi acture or dislocation);
-Spinal stenosis: -
-Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
-
Tumor:
-
-Pseudoarthrosis; and Failed previous fusion
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWQ, KWP
Device Description
The Proposed system is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated screws , rods (Straight and pre-bent) , connectors , hooks and setscrews. The Artfx Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.
ARTFX SPINAL FIXATION SYSTEM is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-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
noncervical 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 was performed in accordance with ASTM F1717 (static and dynamic compression bending, static torsion), and ASTM F1798 (axial grip, torsional grip, static flexion-extension). The results demonstrated substantially equivalent mechanical performance of the subject 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.
K171497, K091445, K994121, K071371
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
§ 888.3070 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.
0
April 20, 2023
Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ArtFX Medical LLC Ozgen Ozfidan CEO 50 Laura St. N., 25th Floor Jacksonville, Florida 32202
Re: K212220
Trade/Device Name: ArtFX Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: March 16, 2023 Received: March 24, 2023
Dear Ozgen Ozfidan:
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
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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212220
Device Name ARTEX SPINAL FIXATION SYSTEM
ARTEX SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as an anterior anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
-Degenerative dise disease (DDD) (defined as back pain of discogenic origin with degeneration of the dise confirmed by history and radiographic studies): .
-Spondylolisthesis;
-
Trauma (i.e. fi acture or dislocation);
-Spinal stenosis: -
-Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
-
Tumor:
-
-Pseudoarthrosis; and Failed previous fusion
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
(as required by 21 CFR 807.92)
Owner/Submitter Information
ARTFX MEDICAL LLC Owner: 50 LAURA ST N 25TH FLOOR, JACKSONVILLE, FL, 32202 USA Address: Phone: +1 917 445 2085 Date Prepared: April 17, 2023 Contact Person: OZGEN OZFIDAN E-mail : ozgen@artfxmed.com
ESTABLISHMENT REGISTRATION: 3017435639
Device Information
- Common Name: Thoracolumbosacral pedicle screw system
- Trade Name: ARTFX SPINAL FIXATION SYSTEM
- Classification name: Thoracolumbosacral pedicle screw system (21 CFR 888.3070)
- Orthopedic Device Panel:
- NKB,KWQ,KWP Product codes:
- Proposed Class: II
4
PREDICATE DEVICES:
| Primary Predicate | Additional Predicate | Additional Predicate | Additional Predicate | |
|---|---|---|---|---|
| 510(k) Number | K171497 | K091445 | K994121 | K071373 |
| Manufacturer | Mikron Makina Sanayi | |||
| Ticaret Co. Ltd. | Medtronic Sofamor Danek | |||
| USA | Synthes | Stryker Spine | ||
| Trade Name | Mikron Spinal Fixation | |||
| System | CD HORIZON Spinal System | USS Small | ||
| Stature | XIA 3 Spinal | |||
| System |
Substantial Equivalence/Technological Comparison
The proposed devices are substantially equivalent to the devices Mikron Spinal Fixation System (K171497), CD HORIZON Spinal System (K091445), USS Small Stature (K994121) and XIA 3 Spinal System (K071371). These devices has the same intended use, technological characteristics and basic design as the proposed device.
Device Description
The Proposed system is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated screws , rods (Straight and pre-bent) , connectors , hooks and setscrews. The Artfx Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.
ARTFX SPINAL FIXATION SYSTEM is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.
5
Indications for Use
ARTFX SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and nonpedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
-Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
-Spondylolisthesis;
-Trauma (i.e. fracture or dislocation);
-Spinal stenosis;
-Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
-Tumor;
-Pseudoarthrosis; and Failed previous fusion
Performance Testing:
Non-clinical testing was performed in accordance with ASTM F1717 (static and dynamic compression bending, static torsion), and ASTM F1798 (axial grip, torsional grip, static flexion-extension). The results demonstrated substantially equivalent mechanical performance of the subject device.
Conclusions:
ArtFX SPINAL FIXATION SYSTEM has similar technological characteristics as the predicate devices, including the materials, design, function, range of sizes, manufacturing processes, surgical techniques, and intended use. The minor differences in design and sizing options do not present new issues of safety and effectiveness. The intended use and material of the subject ARTFX SPINAL FIXATION SYSTEM is identical to this of the predicate devices. The information presented demonstrates the substantial equivalence of the subject device.