Republic Spine Dark Star Spinal System

K150283 · Republic Spine, LLC · MNH · Apr 29, 2015 · Orthopedic

Device Facts

• Record ID: K150283
• Device Name: Republic Spine Dark Star Spinal System
• Applicant: Republic Spine, LLC
• Product Code: MNH · Orthopedic
• Decision Date: Apr 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

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-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)

Device Story

Multi-component posterior spinal fixation system; consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. Used by surgeons in clinical settings to build spinal implant constructs; provides immobilization and stabilization of spinal segments to promote fusion. Implanted via posterior approach to thoracic, lumbar, and sacral spine. Benefits patients by stabilizing unstable or deformed spinal segments. System components are non-sterile, single-use.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing including static/dynamic compression bending, static torsion, static torque to failure, axial pullout, and torsional/axial/flexural grip testing per ASTM F1717-13, ASTM F543-07, and ASTM F1798-97.

Technological Characteristics

Pedicle screw spinal system; components made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Mechanical testing performed per ASTM F1717-13, ASTM F543-07, and ASTM F1798-97. Non-sterile, single-use implants.

Indications for Use

Indicated for skeletally mature patients requiring posterior, non-cervical pedicle fixation for immobilization and stabilization of thoracic, lumbar, and sacral (T1-S1) spinal segments as an adjunct to fusion. Conditions include severe spondylolisthesis (grades 3-4, L5-S1), degenerative spondylolisthesis with neurologic impairment, trauma (fracture/dislocation), spinal stenosis, spinal curvature (scoliosis, kyphosis, lordosis), tumor, and pseudoarthrosis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• STARFIRE Pedicle Screw System (K102204)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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#

| 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 |
| email | [e-mail] |

| 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)<br>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<br>spinal fixation system which consists of pedicle screws, rods, locking<br>spacers, and cross-linking mechanism. The system contains non-sterile<br>single use titanium alloy (Ti-6Al-4V ELI) implantable components that<br>comply with ASTM F136. Various sizes of these implants are available.<br>Instrumentation is available for the delivery and removal of the Republic<br>Spine Dark Star Spinal System. The system allows the surgeon to build a<br>spinal implant construct to stabilize and promote spinal fusion. |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Indications and<br>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<br>Characteristics<br>and Substantial<br>Equivalence | Documentation was provided to demonstrate that the Republic Spine Dark<br>Star Spinal System is substantially equivalent to the legally marketed<br>Predicate. The devices and accessories included in the Subject device and<br>the predicate devices are both pedicle screw systems as defined in 21 CFR |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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| 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<br>Management Plan. |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | All testing met or exceeded the requirements as established by the test<br>protocols and applicable standards. A review of the mechanical data<br>indicates that the components of the Subject device are capable of<br>withstanding expected loads without failure. The Subject device was<br>therefore found to be substantially equivalent to the Predicates. Clinical<br>data was not needed to support the safety and effectiveness of the Subject<br>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,<br>and comparison to predicate devices, the Subject Republic Spine Dark Star<br>Spinal System has been shown to be substantially equivalent to legally<br>marketed predicate device. |