(280 days)
The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine 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:
• 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;
• Curvature (i.e. scoliosis, kyphosis, and/or lordosis);
• Tumor;
• Pseudoarthrosis; and
• Failed previous fusion.
The Republic Spine Dark Star Spinal System is a multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. The system contains non-sterile single use titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chromium (CoCr per ASTM F1537). Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Spinal System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.
The scope of the Republic Spine Dark Start Spinal System is being extended via a line extension to include additional rods, connectors, hooks and screws. New instrumentation will also be introduced to aid in the implantation of the new implants.
The safety and effectiveness of the fenestrated screw have not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). The fenestrated screws are intended to be used with saline or radiopaque dye.
This is a medical device submission for the Republic Spine Dark Star Spinal System, which is a multi-component posterior spinal fixation system. As such, the acceptance criteria and performance data are based on non-clinical (mechanical) testing rather than clinical performance (like an AI/CAD system would require).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Test Type | Reported Device Performance |
|---|---|---|
| ASTM F1717 | Static Axial Compression Bending | Subjected to testing per required standards. |
| ASTM F1717 | Dynamic Axial Compression Bending | Subjected to testing per required standards. |
| ASTM F1717 | Static Torsion | Subjected to testing per required standards. |
| ASTM F1798 | Static Axial Grip, Torsional Grip | Subjected to testing per required standards. |
Note: The document states "The subject Republic Dark Star Spinal System implants were subjected to the following verification testing per required standards to establish substantial equivalent performance to the predicate device." It does not provide specific numerical results or pass/fail thresholds for these tests, rather it indicates that the tests were performed and the device demonstrated "substantial equivalent performance."
2. Sample size used for the test set and the data provenance
For the non-clinical performance data, the "sample size" refers to the number of devices or components tested for each mechanical test. The document does not explicitly state the exact number of samples tested for each ASTM standard.
- Data Provenance: The tests are described as "verification testing" performed on the "subject Republic Dark Star Spinal System implants." This implies in-house laboratory testing conducted by the manufacturer to demonstrate substantial equivalence to the predicate device. There is no information regarding the country of origin of the data as these are mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of medical device submission. Ground truth established by experts is typically relevant for diagnostic or clinical evaluation of devices (e.g., AI/CAD systems interpreting images). For mechanical spinal implants, the "ground truth" is defined by the performance requirements of established ASTM standards.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical evaluations or image interpretations where multiple experts assess the same cases. Mechanical testing follows standardized protocols, and results are typically objective measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of medical images, often with AI assistance. This submission is for a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. "Standalone performance" refers to the evaluation of an AI algorithm without human involvement. This submission is for a physical medical implant, not an algorithm.
7. The type of ground truth used
For this device, the "ground truth" is based on engineering standards and design specifications. The device's performance is compared against the established mechanical properties and performance characteristics required by the referenced ASTM standards (ASTM F1717 and ASTM F1798) and its predicate device.
8. The sample size for the training set
This question is not applicable. "Training set" is a concept used in machine learning for AI algorithms. For a mechanical implant, there is no "training set" in this context. The manufacturing process and design are based on engineering principles and material science, not statistical training data.
9. How the ground truth for the training set was established
This question is not applicable for the reasons mentioned in point 8. The "ground truth" for the design and manufacturing of the device is established by adherence to recognized engineering standards, material specifications, and quality control processes.
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March 5, 2021
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Republic Spine, LLC James Doulgeris Director of Product Development and Quality Systems 2424 N Federal Hwy, STE 257 Boca Raton, Florida 33431
Re: K201420
Trade/Device Name: Republic Spine Dark Star Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: January 26, 2021 Received: January 27, 2021
Dear James Doulgeris:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 (OS) 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, 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) K201420
Device Name
Republic Spine Dark Star Spinal System
Indications for Use (Describe)
The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine 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: · 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:
- · Curvature (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)
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510(k) Summary
| Sponsor | Republic Spine, LLC2424 North Federal HwySuite 257Boca Raton, FL, 33431 |
|---|---|
| Establishment Number | 3011796723 |
| Point of Contact | James Doulgeris2424 North Federal HwySuite 257Boca Raton, FL, 33431561-362-8094 |
| Date | 27 January, 2021 |
| Trade Name | Republic Spine Dark Star Spinal System |
| Common Name | Spinal Pedicle Fixation Device |
| Classification Panel | Orthopedic |
| Classification | Class II |
| Regulation No. | 21 CFR 888.3070, 21 CFR 888.3050 |
| Regulation Name | Thoracolumbosacral pedicle screw system,Spinal interlaminal fixation orthosis |
| Product Code | NKB, KWP |
| Primary Predicate Device | K181495, Republic Spine Dark Star Spinal System |
| Additional Predicate Devices | K193100, OrthoPediatrics, Corp.K180179, K141186, Orthofix IncK171421, VERTICALE® Posterior Spinal Fixation System |
| Device Description | The Republic Spine Dark Star Spinal System is a multi-component posteriorspinal fixation system which consists of pedicle screws, rods, locking spacers,and cross-linking mechanism. The system contains non-sterile single usetitanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chromium (CoCr perASTM F1537). Various sizes of these implants are available. Instrumentationis available for the delivery and removal of the Republic Spine Dark Star SpinalSystem. The system allows the surgeon to build a spinal implant construct tostabilize and promote spinal fusion.The scope of the Republic Spine Dark Start Spinal System is being extendedvia a line extension to include additional rods, connectors, hooks and screws.New instrumentation will also be introduced to aid in the implantation of the newimplants.The safety and effectiveness of the fenestrated screw have not beenestablished when used in conjunction with bone cement or for use in patients |
| with poor bone quality (e.g., osteoporosis, osteopenia). The fenestrated screws | |
| are intended to be used with saline or radiopaque dye. | |
| Intended Use/Indications for Use | The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilizationof spinal segments in skeletally mature patients as an adjunct to fusion in thetreatment of the following acute and chronic instabilities or deformities of thethoracic, lumbar, and sacral spine:• Degenerative Disc Disease (DDD) (defined as back pain of discogenic originwith degeneration of the disc confirmed by history and radiographic studies);• Spondylolisthesis;• Trauma (i.e. fracture or dislocation);• Spinal stenosis;• Curvature (i.e. scoliosis, kyphosis, and/or lordosis);• Tumor;• Pseudoarthrosis; and• Failed previous fusion. |
| NonclinicalPerformance Data | The subject Republic Dark Star Spinal System implants were subjected to thefollowing verification testing per required standards to establish substantialequivalent performance to the predicate device.• ASTM F1717: Static Axial Compression Bending• ASTM F1717: Dynamic Axial Compression Bending• ASTM F1717: Static Torsion• ASTM F1798: Static Axial Grip, Torsional Grip |
| ClinicalPerformance Data | Clinical performance data is not required to demonstrate substantialequivalence to the predicate device. |
| SubstantialEquivalenceConclusion | Substantial equivalence of the subject device and predicate device(s) isbased on the following:• The modified and predicate device(s) have the same intended use.• The modified and predicate devices(s) operate using the same fundamentalscientific technology.• The modified and predicate devices(s) share the same functional andtechnological characteristics via the same operational principles.Evaluation of the risks and performance data of the subject devicedemonstrates it is substantially equivalent to predicate devices. |
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§ 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.