(238 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests of the implants.
Yes
The device is a medical implant system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, which qualifies it as a therapeutic device for treating various spinal conditions.
No
The device is a pedicle screw system intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and promote fusion, not for diagnosis.
No
The device description explicitly states it is a multi-component posterior spinal fixation system consisting of physical implants like pedicle screws, set screws, rods, hooks, connectors, and crosslinks, manufactured from titanium alloy and Cobalt Chromium. This indicates it is a hardware-based medical device, 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 used for stabilizing the spine in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description details physical components like screws, rods, hooks, and connectors made of specific materials. These are all components of a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide information for diagnosis.
- Performance Studies: The performance studies listed are mechanical tests (static and dynamic bending, torsion, grip) relevant to the structural integrity and function of a spinal implant, not diagnostic accuracy.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is implanted in vivo (inside the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The Republic Spine Dark Deformity Pedicle Screw System is intended for posterior, non-cervical pedicle 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:
- 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
- . Failed previous fusion
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Dark Star Deformity Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Dark Star Deformity Pedicle Screw System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/ or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP
Device Description
The Republic Spine Dark Star Deformity Pedicle Screw System (previously cleared as Dark Star Spinal System) is a multi-component posterior spinal fixation system which consists of pedicle screws, set screws, rods, hooks, connectors, and crosslinks. The system contains non-sterile single use components manufactured from 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 Deformity Pedicle Screw 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 Star Deformity Pedicle Screw System is being extended with this submission via a line extension to offer new implant options including connectors, prebent rods, crosslinks, and hooks and to offer implant design modifications to the uniplanar screws, to the connectors, and to the hooks. New instrumentation will also be introduced to aid in the implantation of the new and existing implants. The indications for use are being expanded to include pediatric applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic, Lumbar, and Sacral spine
Indicated Patient Age Range
Skeletally mature patients, pediatric 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
The subject Dark Star Deformity Pedicle Screw System implants were subjected to the following abbreviated verification testing per required standards to establish substantial equivalent performance to the predicate device.
- ASTM F1717: Static Axial Compression Bending
- ASTM F1717: Dynamic Axial Compression Bending
- ASTM F1717: Static Torsion
- ASTM F1798: Axial Grip
- ASTM F1798: TORSION GRIP
Key Metrics
Not Found
Predicate Device(s)
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.
0
May 26, 2023
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.
Republic Spine, LLC James Doulgeris Director of Product Development and Quality Systems 2424 N Federal HW, Suite 257 Boca Raton, Florida 33431
Re: K223096
Trade/Device Name: Dark Star Deformity Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: May 18, 2023 Received: May 19, 2023
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
1
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 (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 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 -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223096
Device Name
Dark Star Deformity Pedicle Screw System
Indications for Use (Describe)
The Republic Spine Dark Deformity Pedicle Screw System is intended for posterior, non-cervical pedicle 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:
- 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
- . Failed previous fusion
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Dark Star Deformity Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Dark Star Deformity Pedicle Screw System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/ or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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
| Submitter's Name: | Republic Spine, LLC |
|---|---|
| Submitter's Address: | 2424 North Federal Hwy, Suite 257 |
| Boca Raton, FL 33431 | |
| Submitter's Telephone: | 561-334-2421 |
| Contact Person: | James Doulgeris |
| 727-512-5461 | |
| James@rspine.com | |
| Date Summary was Prepared: | May 18, 2023 |
| Trade or Proprietary Name: | Dark Star Deformity Pedicle Screw System |
| Common or Usual Name: | Spinal Pedicle Fixation Device, |
| Spinal Interlaminar Fixation Orthosis | |
| Classification: | Class II per 21 CFR §888.3050 |
| Class II per 21 CFR §888.3070 | |
| Product Code: | NKB, KWP |
| Classification Panel: | Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Republic Spine Dark Star Deformity Pedicle Screw System (previously cleared as Dark Star Spinal System) is a multi-component posterior spinal fixation system which consists of pedicle screws, set screws, rods, hooks, connectors, and crosslinks. The system contains non-sterile single use components manufactured from 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 Deformity Pedicle Screw 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 Star Deformity Pedicle Screw System is being extended with this submission via a line extension to offer new implant options including connectors, prebent rods, crosslinks, and hooks and to offer implant design modifications to the uniplanar screws, to the connectors, and to the hooks. New instrumentation will also be introduced to aid in the implantation of the new and existing implants. The indications for use are being expanded to include pediatric applications.
INDICATIONS FOR USE
The Republic Spine Dark Star Deformity Pedicle Screw System is intended for posterior, noncervical 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:
4
- 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
- Failed previous fusion ●
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Dark Star Deformity Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Dark Star Deformity Pedicle Screw System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specially, the following characteristics are identical between the subject and predicates:
- Indications for Use ●
- Materials of manufacture ●
- Principles of Operation .
- Fundamental scientific technologies ●
- Functional technological characteristics ●
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product
Code | Predicate
Type |
|-------------|------------------------------------|---------------------|-----------------|-------------------|
| K201420 | Dark Star Spinal System | Republic Spine, LLC | NKB, KWP | Primary |
| K142381 | Xia® 3 Spinal System | Stryker Spine | NKB, KWP | Additional |
PERFORMANCE DATA
The subject Dark Star Deformity Pedicle Screw System implants were subjected to the following abbreviated verification testing per required standards to establish substantial equivalent performance to the predicate device.
- ASTM F1717: Static Axial Compression Bending ●
- ASTM F1717: Dynamic Axial Compression Bending ●
5
- ASTM F1717: Static Torsion .
- ASTM F1798: Axial Grip ●
- ASTM F1798: TORSION GRIP .
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the subject Dark Star Deformity Pedicle Screw System is substantially equivalent to the predicate device.