(16 days)
Not Found
No
The document describes a spinal fixation system and its intended use, device description, and performance testing. There is no mention of AI or ML technology.
Yes.
The device is a spinal fixation system intended to improve the stability of the spine and is used to treat various spinal conditions like degenerative disc disease, spondylolisthesis, spinal stenosis, etc., which are therapeutic purposes.
No
This device is a spinal fixation system intended to improve stability, not diagnose conditions. Its intended use focuses on treatment after a diagnosis has already been made (e.g., degenerative disc disease, spinal stenosis).
No
The device description clearly states it is a "spinal fixation system" with "components" and "rods," indicating it is a physical hardware device intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for spinal fixation and stabilization, used in vivo (within the body) to treat various spinal conditions. This is a surgical implant.
- Device Description: The description confirms it's a spinal fixation system with components like rods and screws, designed to be implanted in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is an implantable medical device used inside the body.
N/A
Intended Use / Indications for Use
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.
The components in the Solanas® Posterior System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods.
- Degenerative Disc Disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- Spondylolisthesis
- Spinal Stenosis
- Fracture/Dislocation
- Atlanto/Axial fracture with instability
- Revision of previous cervical spine surgery
- Tumors.
Product codes
NKB, KWP
Device Description
The Solanas® Posterior Stabilization System is a spinal fixation system intended to improve stability of the occipital, cervical, and thoracic areas of the spine (C1-T3).
The purpose of this submission is to obtain premarket clearance for Co-Cr28-Mo6 rods for the Solanas® Posterior Stabilization System and to demonstrate that the subject device, Solanas® Posterior Stabilization System, is substantially equivalent to the predicate devices. Co-Cr28-Mo6 rods are for cervical/thoracic use only.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
occipital, cervical, and thoracic areas of the spine (C1-T3)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance data and engineering analysis demonstrate that the subject Solanas System is substantially equivalent to the predicates. Testing and analysis include Static and Dynamic Compression Bending, Static and Dynamic Torsion and Axial Grip.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
November 30, 2017
Alphatec Spine, Inc Natalia Shirina Regulatory Affairs Project Manager 5818 El Camino Real Carlsbad, California 92008
Re: K173522
Trade/Device Name: Solanas® Posterior Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw Systems Regulatory Class: Class II Product Code: NKB, KWP Dated: November 13, 2017 Received: November 14, 2017
Dear Natalia Shirina:
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, 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) 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@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S for
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)
K173522
Device Name Solanas® Posterior Stabilization System
Indications for Use (Describe)
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.
The components in the Solanas® Posterior System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods.
· Degenerative Disc Disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- · Spondylolisthesis
- · Spinal Stenosis
- Fracture/Dislocation
- Atlanto/Axial fracture with instability
- · Revision of previous cervical spine surgery
- Tumors.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| ------------------------------------------------------------- | ------------------------------------------------------------ |
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510(k) Summary K173522
November 30, 2017
| I. | SUBMITTER: | Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|----|-----------------|-------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Natalia Shirina
Regulatory Affairs Project Manager
Contact Phone: (760) 494-6740 |
Date Summary Prepared:
II. DEVICE
| Name of Device: | Solanas® Posterior Stabilization System |
|---|---|
| Common or Usual Name: | Occipital Cervical Thoracic System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| (21 CFR 888.3070) | |
| Spinal Interlaminal Fixation Orthosis | |
| (21 CFR 888.3050) | |
| Regulatory Class: | Class II |
| Product Code: | NKB, KWP |
III. PREDICATE DEVICE
Alphatec Spine, Inc., Solanas® Posterior Stabilization System, K071380 (Primary Predicate) Medicrea International, PASS OCT Spinal System, K150918 (Additional Predicate)
DEVICE DESCRIPTION IV.
The Solanas® Posterior Stabilization System is a spinal fixation system intended to improve stability of the occipital, cervical, and thoracic areas of the spine (C1-T3).
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The purpose of this submission is to obtain premarket clearance for Co-Cr28-Mo6 rods for the Solanas® Posterior Stabilization System and to demonstrate that the subject device, Solanas® Posterior Stabilization System, is substantially equivalent to the predicate devices. Co-Cr28-Mo6 rods are for cervical/thoracic use only.
V. INDICATIONS FOR USE
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.
The components in the Solanas® Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods.
- . Degenerative Disc Disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- Spondylolisthesis ●
- Spinal Stenosis ●
- Fracture/Dislocation
- Atlanto/Axial fracture with instability ●
- Revision of previous cervical spine surgery ●
- Tumors. ●
TECHNOLOGICAL COMPARISON TO PREDICATES VI.
The technological design features of the subject Solanas implants were compared to the predicates in intended use, design, function, materials, and sizes and it was demonstrated that they are substantially equivalent.
VII. PERFORMANCE DATA
Performance data and engineering analysis demonstrate that the subject Solanas System is substantially equivalent to the predicates. Testing and analysis include Static and Dynamic Compression Bending, Static and Dynamic Torsion and Axial Grip.
VIII. CONCLUSION
Based upon the information provided in this Special 510(k) submission, it has been determined that the subject Solanas System devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.