(83 days)
Not Found
No
The device description and performance studies focus on mechanical properties and traditional spinal fixation components, with no mention of AI/ML or related concepts.
Yes
The device is described as a "multi-component posterior spinal fixation system" intended for "immobilization and stabilization of spinal segments" as "an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine." This functionality, including providing stabilization and promoting spinal fusion to treat medical conditions, aligns with the definition of a therapeutic device.
No
The device is a multi-component posterior spinal fixation system designed to provide immobilization and stabilization of spinal segments, acting as an adjunct to fusion. It is an implant used for treatment, not for diagnosing 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. This is a hardware-based medical device.
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 device is 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." This describes a surgical implant used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The device is described as a "multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism." These are physical implants designed to be surgically placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically tests or assays performed in vitro (outside the body).
Therefore, the Republic Spine Dark Star Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
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 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): · Severe Spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra
- · Degenerative spondylolisthesis with objective evidence of neurologic impairment
- · Trauma (i.e. fracture or dislocation)
- · Spinal stenosis
- · Curvature (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- · Pseudoarthrosis (failed previous fusion)
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI
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 contains non-sterile single use titanium alloy (Ti-6Al-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 potential hazards have been evaluated and controlled through a Risk Management Plan. All testing met or exceeded the requirements as established by the test protocols and applicable standards. A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure. The Subject device was therefore found to be substantially equivalent to the Predicates. Clinical data was not needed to support the safety and effectiveness of the Subject Device. The following mechanical testing was performed: ASTM 1717 Static Compression Bending ASTM 1717 Dynamic Compression Bending ASTM 1717 Static Torsion ASTM F543-07: Static Torque to Failure ASTM F543-07: Axial Pullout ASTM F1798-97: Torsional, Axial and Flexural Grip
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines beneath them, resembling a bird or abstract form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Republic Spine, LLC % Ms. Chervl L. Wagoner Wagoner Consulting, LLC P.O. Box 15729 Wilmington, North Carolina 28408
Re: K150283
Trade/Device Name: Republic Spine Dark Star Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: April 9, 2015 Received: April 10, 2015
Dear Ms. Wagoner:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Cheryl L. Wagoner
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
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) K150283
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 (T1-S1): · Severe Spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra
- · Degenerative spondylolisthesis with objective evidence of neurologic impairment
- · Trauma (i.e. fracture or dislocation)
- · Spinal stenosis
- · Curvature (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- · Pseudoarthrosis (failed previous fusion)
X 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
| Date Prepared | April 24, 2015 |
|---|---|
| Submitter | Republic Spine LLC |
| Address | 3200 NE 14th Street Causeway |
| Suite 250 | |
| Pompano Beach, FL 33062 | |
| Telephone | 954-249-0817 |
| Fax | 954-301-3343 |
| Contact Person | Rusty McCarver |
| Chief Operating Officer | |
| rusty@rspine.com |
| Trade Name | Republic Spine Dark Star Spinal System |
|---|---|
| Common Name | Spinal Pedicle Fixation Device |
| Panel Code | Orthopaedics/87 |
| Classification Name | Spondylolisthesis Spinal Fixation Device System (MNH) |
| Pedicle Screw Spinal System (MNI) | |
| Class | Class II (Special Controls) |
| Regulation Number | 21 CFR 888.3070 |
| Product Code | MNH, MNI |
| Predicate Device Name | 510(k) Number | Manufacturer |
|---|---|---|
| STARFIRE Pedicle Screw System | K102204 | Choice Spine |
| 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 contains non-sterile
single use titanium alloy (Ti-6Al-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 and
| Intended Use | 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 (T1-S2): Severe Spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra Degenerative spondylolisthesis with objective evidence of neurologic impairment Trauma (i.e. fracture or dislocation) Spinal stenosis Curvature (i.e. scoliosis, kyphosis, and/or lordosis) Tumor Pseudoarthrosis (failed previous fusion) |
|---|---|
| --------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Technological
Characteristics
and Substantial
Equivalence | 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 |
| -------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
4
| 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. Testing in |
| accordance with ASTM 1717-13, ASTM F543-07, and ASTM F1798-97 |
| shows the mechanical strength of the subject device to be equivalent or |
| better than the predicate devices. |
| Performance Data | The potential hazards have been evaluated and controlled through a Risk
Management Plan. |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | All testing met or exceeded the requirements as established by the test
protocols and applicable standards. A review of the mechanical data
indicates that the components of the Subject device are capable of
withstanding expected loads without failure. The Subject device was
therefore found to be substantially equivalent to the Predicates. Clinical
data was not needed to support the safety and effectiveness of the Subject
Device. |
| | The following mechanical testing was performed: |
| | ASTM 1717 Static Compression Bending ASTM 1717 Dynamic Compression Bending ASTM 1717 Static Torsion ASTM F543-07: Static Torque to Failure ASTM F543-07: Axial Pullout ASTM F1798-97: Torsional, Axial and Flexural Grip |
| Conclusion | Based on design, materials, intended use, technological characteristics,
and comparison to predicate devices, the Subject Republic Spine Dark Star
Spinal System has been shown to be substantially equivalent to legally
marketed predicate device. |