(112 days)
No
The device description and intended use describe a mechanical spinal fixation system with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a spinal fixation system intended to provide additional support during fusion for various spinal instabilities and deformities, which are clinical treatments.
No
Explanation: The device is a spinal fixation system intended to provide support during fusion, which is a therapeutic intervention, not a diagnostic one. Its purpose is to stabilize the spine, not to identify or characterize a medical condition.
No
The device description explicitly lists physical components such as screws, rods, connectors, and hooks, indicating it is a hardware-based spinal fixation system, not software only.
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 system for stabilizing the spine during fusion. This is a therapeutic device used in vivo (within the body), not a diagnostic device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The description details physical components like screws, rods, and hooks, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements associated with in vitro diagnostics.
Therefore, the MSFX MIKRON SPINAL FIXATION SYSTEM is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
MSFX MIKRON SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the MSFX MIKRON SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in the treatment of 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
Product codes
NKB, KWP
Device Description
Msfx Mikron System is a top-loading, multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (Straight and curved) , connectors , hooks and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-EL) that conforms to ASTM F136. Various sizes of these components are available.
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)
Biomechanical tests of the Mikron Spinal Fixation System are performed according to ASTM F2193 and ASTM F1717.
The Msfx Mikron Spinal Fixation System is substantially equivalent to the predicate device currently cleared under K171497 as it has the same intended use, same design, principle of operation and technological characteristics. No new questions of safety or effectiveness have been raised as compared to the predicate. Performance testing has demonstrated that the Msfx Mikron Spinal Fixation System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K171497, K212220, K091445, K071373
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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Mikron Makina Sanayi ve Ticaret Ltd. Sti. Mustafa Ekiz Medical Devices Manager Ivedik OSB Mah. 1372. Sok. No:31 Yenimahalle/Ankara/TURKEY Yenimahalle. Ankara 06378 Turkev
Re: K241657
Trade/Device Name: Msfx Mikron Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: June 3, 2024 Received: June 10, 2024
Dear Mustafa Ekiz:
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).
September 30, 2024
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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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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).
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Sincerely, Digitally signed Eileen by Eileen Cadel Cadel --S
Date: 2024.09.30 S 14:42:00 -04'00' 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
Enclosure
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Indications for Use
510(k) Number (if known) K241657
Device Name MSFX MIKRON SPINAL FIXATION SYSTEM
Indications for Use (Describe)
MSFX MIKRON SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the MSFX MIKRON SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in the treatment of 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
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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| 510(k) #: K241657 | 510(k) Summary | K241657 | Page 1 of 2 | ||
|---|---|---|---|---|---|
| Prepared on: 2024-08-24 | |||||
| Contact Details | 21 CFR 807.92(a)(1) | ||||
| Applicant Name | Mikron Makina Sanayi ve Ticaret Ltd. Sti. | ||||
| Applicant Address | Ivedik OSB Mah. 1372. Sok. No:31 Yenimahalle/Ankara/TURKEY | ||||
| Yenimahalle Ankara 06378 Turkey | |||||
| Applicant Contact Telephone | +903128020066 | ||||
| Applicant Contact | Mr. MUSTAFA EKIZ | ||||
| Applicant Contact Email | mustafaekiz@mikronmakina.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | MSFX MIKRON SPINAL FIXATION SYSTEM | ||||
| Common Name | Thoracolumbosacral pedicle screw system | ||||
| Classification Name | Thoracolumbosacral Pedicle Screw System | ||||
| Regulation Number | 888.3070 | ||||
| Product Code(s) | NKB, KWP | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K171497 | Mikron Spinal Fixation system | NKB | |||
| K212220 | Artfx Spinal Fixation System | NKB | |||
| K091445 | CD HORIZON SPINAL SYSTEM | NKB | |||
| K071373 | XIA 3 Spinal System | NKB |
Device Description Summary
Msfx Mikron System is a top-loading, multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (Straight and curved) , connectors , hooks and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-EL) that conforms to ASTM F136. Various sizes of these components are available.
21 CFR 807.92(a)(4)
21 CFR 807.92(a)(5)
Intended Use/Indications for Use
MSFX MIKRON SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the MSFX MIKRON SYSTEM is intended to provide additional support during fusion using autograft in skeletally mature patients in 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
5
-Trauma (i.e. fracture or dislocation) -Spinal stenosis -Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) -Tumor -Pseudoarthrosis; and failed previous fusion
Indications for Use Comparison
Msfx Mikron Spinal Fixation System has the same indications for use with the predicate devices indicated.
Technological Comparison
Msfx Mikron 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.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Biomechanical tests of the Mikron Spinal Fixation System are performed according to ASTM F2193 and ASTM F1717.
The Msfx Mikron Spinal Fixation System is substantially equivalent to the predicate device currently cleared under K171497 as it has the same intended use, same design, principle of operation and technological characteristics. No new questions of safety or effectiveness have been raised as compared to the predicate. Performance testing has demonstrated that the Msfx Mikron Spinal Fixation System is substantially equivalent to the predicate device.