(21 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural support provided by the plating system, with no mention of AI or ML technology.
Yes
The device is a spinal intervertebral body fixation orthosis intended to provide structural stability and mechanical support to the spine for various acute and chronic instabilities or deformities, which directly addresses the treatment or mitigation of disease.
No
This device is a spinal intervertebral body fixation orthosis intended to provide structural stability and mechanical support, not to diagnose a condition.
No
The device description explicitly states that the system consists of implants, screws, and instrumentation made from various metal alloys, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The MiRus MoRe Lumbar Plating System is a spinal implant intended to provide structural stability and mechanical support to the spine during fusion. It is surgically implanted into the patient's body.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens from the patient. Its function is purely mechanical support within the body.
Therefore, the MiRus MoRe Lumbar Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MiRus MoRe Lumbar Plating System is indicated for use via lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the following acute and chronic instabilities or deformities:
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Pseudoarthrosis;
- · Spondylolysis:
- · Spondylolisthesis;
- · Spinal stenosis;
- · Tumors;
- · Trauma (i.e. Fractures or Dislocation);
- · Deformities (i.e. Scoliosis, Kyphosis or Lordosis);
- · Failed Previous Fusion
Product codes
KWQ
Device Description
The MiRus MoRe Lumbar Plating System is a spinal intervertebral body fixation orthosis intended to provide structural stability and mechanical support to the lumbar spine following lumbar interbody fusion.
The MiRus MoRe Lumbar Plating System consists of implants manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, screws and locking cam mechanism manufactured from Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The MiRus MoRe Lumbar Plating System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements: ANTARES" Anterior Lumbar Plate and MiRus Lateral Lumbar Plate.
The plates are provided sterile packed and are intended for single use only. The screws must be steam sterilized prior to use.
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)
The mechanical performance profile of the MoRe Lumbar Plating System was assessed through static and dynamic testing in accordance with the following test methods:
- · Static compression bending testing (ASTM F1717-21)
- · Static torsion testing (ASTM F1717-21)
- · Dynamic compression bending testing (ASTM F1717-21)
The MiRus MoRe Lumbar Plating System was compared to the performance criteria disclosed in a recent FDA Guidance document "Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff":
- · Guidance for Industry and FDA Staff – Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway, Issued on December 11, 2020
The guidance document presents acceptable values for performance testing per ASTM F1717. A comparison of the mechanical performance testing of the MiRus MoRe Lumbar Plating System to this FDA Guidance demonstrates that the MiRus MoRe Lumbar Plating System is substantially equivalent to other legally marketed systems.
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.
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
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.
0
May 17, 2024
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 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.
MiRus, LLC Anuradha Nagulapati Senior Regulatory Affairs Engineer 1755 W. Oak Parkway Suite 100 Marietta, Georgia 30062
Re: K241175
Trade/Device Name: MiRus MoRe Lumbar Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 26, 2024 Received: April 26, 2024
Dear Anuradha Nagulapati:
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).
1
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,
Image /page/1/Picture/6 description: The image shows a digital signature for Eileen Cadel. The signature includes the name "Eileen Cadel" on the left side of the image. On the right side, it states "Digitally signed by Eileen Cadel" followed by the date "2024.05.17" and the time "14:34:53 -04'00'".
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
MiRus MoRe Lumbar Plating System
Indications for Use (Describe)
The MiRus MoRe Lumbar Plating System is indicated for use via lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the following acute and chronic instabilities or deformities:
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Pseudoarthrosis;
- · Spondylolysis:
- · Spondylolisthesis;
- · Spinal stenosis;
- · Tumors;
- · Trauma (i.e. Fractures or Dislocation);
- · Deformities (i.e. Scoliosis, Kyphosis or Lordosis);
- · 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
| K241175 | 510(k) Summary | K241175 Page 1 of 2
Prepared on: 2024-05-15 |
|------------------------------------|----------------------------------------------------------|---------------------------------------------------------------|
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | | MiRus, LLC |
| Applicant Address | | 1755 W. Oak Parkway Suite 100 Marietta GA 30062 United States |
| Applicant Contact Telephone | | 470-428-8684 |
| Applicant Contact | | Ms. Anuradha Nagulapati |
| Applicant Contact Email | | anagulapati@mirusmed.com |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | | MiRus MoRe Lumbar Plating System |
| Common Name | | Spinal intervertebral body fixation orthosis |
| Classification Name | | Appliance, Fixation, Spinal Intervertebral Body |
| Regulation Number | | 888.3060 |
| Product Code(s) | | KWQ |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K150449 | LITETM Plate System | KWQ |
| K220441 | CYGNUSTM MoRe Anterior Cervical Plate System | KWQ |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
The MiRus MoRe Lumbar Plating System is a spinal intervertebral body fixation orthosis intended to provide structural stability and mechanical support to the lumbar spine following lumbar interbody fusion.
The MiRus MoRe Lumbar Plating System consists of implants manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, screws and locking cam mechanism manufactured from Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The MiRus MoRe Lumbar Plating System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements: ANTARES" Anterior Lumbar Plate and MiRus Lateral Lumbar Plate.
The plates are provided sterile packed and are intended for single use only. The screws must be steam sterilized prior to use.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The MiRus MoRe Lumbar Plating System is indicated for use via lateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during
4
fusion in skeletally mature patients in the treatment of the following acute and chronic instablities or deformities: · Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and
- radiographic studies);
- · Pseudoarthrosis;
- · Spondylolysis;
- · Spondylolisthesis;
- · Spinal stenosis;
- · Tumors;
- · Trauma (i.e. Fractures or Dislocation);
- · Deformities (i.e. Scoliosis, Kyphosis or Lordosis);
- · Failed Previous Fusion
Indications for Use Comparison
The indications for the use are the same for the subject device and predicate device.
Technological Comparison
The MiRus MoRe Lumbar Plating System has the same intended use, indications for use, labeling, and technological characteristics as the predicate system, including the same design features, sizes, and materials. The predicate device components are manufactured from titanium alloy (ASTM F136). The MiRus MoRe Lumbar Plating System components are manufactured from titanium alloy (ASTM F136) and molybdenum-rhenium alloy (ASTM F3273), which are the same materials as the reference device. Performance data demonstrate that the MiRus MoRe Plating System is substantially equivalent to other legally marketed predicate systems.
Non-Clinical and/or Clinical Tests Summary & Conclusions
The mechanical performance profile of the MoRe Lumbar Plating System was assessed through static and dynamic testing in accordance with the following test methods:
- · Static compression bending testing (ASTM F1717-21)
· Static torsion testing (ASTM F1717-21)
· Dynamic compression bending testing (ASTM F1717-21)
The MiRus MoRe Lumbar Plating System was compared to the performance criteria disclosed in a recent FDA Guidance document "Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff":
· Guidance for Industry and FDA Staff – Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway, Issued on December 11, 2020
The guidance document presents acceptable values for performance testing per ASTM F1717. A comparison of the mechanical performance testing of the MiRus MoRe Lumbar Plating System to this FDA Guidance demonstrates that the MiRus MoRe Lumbar Plating System is substantially equivalent to other legally marketed systems.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)