(49 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is intended to treat various spinal instabilities and deformities, such as degenerative disc disease and scoliosis, by providing immobilization and promoting spinal fusion. These are therapeutic actions aimed at managing or resolving medical conditions.
No
Explanation: The device is described as a spinal fixation system intended to provide immobilization and promote spinal fusion. Its purpose is treatment, not diagnosis of conditions.
No
The device description explicitly states it is a multi-component posterior spinal fixation system consisting of physical implants (pedicle screws, rods, etc.) made of titanium alloy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Republic Spine Dark Star Spinal System is described as a "multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism." These are implantable components used to stabilize the spine.
- Intended Use: The intended use is for "posterior, non-cervical pedicle rigid fixation of the spine to provide immobilization of spinal segments as an adjunct to fusion." This is a surgical procedure involving the implantation of physical devices.
The device is a surgical implant used to treat structural issues in the spine, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle rigid fixation of the spine to provide immobilization 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 (T1-S1):
- · Degenerative Disc Disease (DDD);
- · 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 (comma separated list FDA assigned to the subject device)
NKB
Device Description
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 is contains non-sterile single use titanium alloy (Ti-6AI-4V ELI) implantable components that comply with ASTM F136. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine (T1-S1)
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 predicate Republic Spine Dark Star Spinal System has been previously tested in the following test modes:
- Static compression bending per ASTM F1717
- Static torsion per ASTM F1717 ●
- Dynamic compression bending per ASTM F1717 ●
- Torsional, Axial and Flexural Grip ASTM F1798-97 ●
The subject modifications do not introduce a new, worst-case compared to the predicate devices tested per the standards identified above. Therefore, additional performance testing was not conducted for the modified devices.
Clinical performance data is not required to demonstrate substantial equivalence to the predicate.
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 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.
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July 25, 2018
Republic Spine, L.L.C. Mr. James Doulgeris Director of Business Development and Quality Systems 350 Camino Gardens Boulevard, Suite 103 Boca Raton, Florida 33432
Re: K181495
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 Dated: June 1, 2018 Received: June 6, 2018
Dear Mr. 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
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K181495
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 rigid fixation of the spine to provide immobilization 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 (T1-S1):
- · Degenerative Disc Disease (DDD);
- · 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) |
|---|
| ------------------------------------------------- |
| Research Use (Part 1, 21 CFR 331 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 331 Subpart C) |
× Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitter's Name: | Republic Spine, LLC |
|---|---|
| Submitter's Address: | 350 Camino Gardens Suite 103 Boca |
| Raton FL 33432 | |
| Submitter's Telephone: | 561-362-8094 |
| Contact Person: | James Doulgeris james@rspine.com |
| Date Summary was Prepared: | 24 July 2018 |
| Trade or Proprietary Name: | Republic Spine Dark Star Spinal System |
| Common or Usual Name: | Thoracolumbosacral Pedicle Screw System |
| Classification: | Class II |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Regulation: | 21 CFR 888.3070 |
| Product Code: | NKB |
| Classification Panel: | Division of Orthopedic Devices |
510(K) SUMMARY
DEVICE DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
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 is contains non-sterile single use titanium alloy (Ti-6AI-4V ELI) implantable components that comply with ASTM F136. 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.
INDICATIONS FOR USE
The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle rigid 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 (T1-S1):
- · Degenerative Disc Disease (DDD);
- · Spondylolisthesis;
- · Trauma (i.e. fracture or dislocation);
- · Spinal stenosis;
- · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
- · Tumor;
- Pseudoarthrosis; and
- Failed previous fusion
PREDICATE DEVICE
Primary Predicate Device
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K150283 | Dark Star Spinal System | Republic Spine |
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NON-CLINICAL PERFORMANCE DATA
The predicate Republic Spine Dark Star Spinal System has been previously tested in the following test modes:
- Static compression bending per ASTM F1717
- Static torsion per ASTM F1717 ●
- Dynamic compression bending per ASTM F1717 ●
- Torsional, Axial and Flexural Grip ASTM F1798-97 ●
The subject modifications do not introduce a new, worst-case compared to the predicate devices tested per the standards identified above. Therefore, additional performance testing was not conducted for the modified devices.
CLINICAL PERFORMANCE DATA
Clinical performance data is not required to demonstrate substantial equivalence to the predicate.
SUMMARY
Documentation was provided to demonstrate that the Republic Spine Dark Star Spinal System is substantially equivalent to the legally marketed predicate. The devices and accessories included in the Subject device and the predicate devices are both pedicle screw systems as defined in 21 CFR 888.3070. The Republic Spine Dark Star Spinal System is substantially equivalent to the predicate devices in intended use, site of application, patient population, conditions of use, mechanical performances, basic design, and operating principles. The Republic Spine Dark Star Spinal System is comparable to its predicate in size and materials. Previous testing in accordance with ASTM 1717-14, and ASTM F1798-97 shows the mechanical strength of the subject device to be equivalent or better than the predicate devices.
SUBSTANTIAL EQUIVALENCE CONCLUSION
Basis of substantial equivalence of the modified device and predicate device is established on the following:
The Republic Spine Dark Star Spinal System and the predicate device system have the following similarities:
- . Both systems have the same Indications for Use. The intended patient population and indications for use of the predicate system are unchanged.
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- Both systems operate using the same fundamental scientific ● technology.
- Both systems incorporate the same basic implant designs. ●
- Both systems are manufactured from the same material. o
- Both systems are provided non-sterile. ●
- Both systems use the same operational principles for the ● surgical implantation of the subject Screws.
The Republic Spine Dark Star Spinal System and the predicate device have the following differences:
- Additional screw sizes (lengths) added for solid, solid low top, . cannulated low top, solid tower pedicle screws, cannulated tower and cannulated reduction pedicle screws.
Evaluation of the risks and performance data based on the differences between the subject device and predicate does not raise any new issues or concerns related to safety or effectiveness. It is concluded that the modified device, the Republic Spine Dark Star Spinal System is as safe and effective as the predicate device for its intended use, and is substantially equivalent to the legally marketed predicate device, the Republic Spine Dark Start Spinal System (K150283).