(95 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a spinal fixation system intended to improve stability of the spine and is used to treat various spinal conditions like degenerative disk disease, spondylolisthesis, and fractures, which indicates a therapeutic purpose.
No.
The device description and intended use indicate it is an implantable spinal fixation system used for stabilization, not for diagnosing conditions.
No
The device description clearly states it is a "spinal fixation system," which is a hardware implant. The performance studies also describe mechanical and dynamic testing of this hardware.
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 for stabilizing the spine. It addresses conditions like degenerative disk disease, spondylolisthesis, spinal stenosis, etc., which are treated through surgical intervention, not by analyzing samples from the body.
- Device Description: The device is described as a "spinal fixation system," which is a type of medical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the SOLANAS III™ Posterior Stabilization System is a surgical implant, not an in vitro diagnostic device.
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 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
- l Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- 피 Spinal Stenosis
- 트 Fracture/Dislocation
- 트 Atlanto/Axial fracture with instability
- 트 Revision of previous cervical spine surgery
- I Tumors
Product codes
NKB, KWP, MNI
Device Description
The SOLANAS III™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical and thoracolumbar area of the spine (C1-T3), C1-C7, upper thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
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)
Mechanical and dynamic testing of the posterior stabilization system was performed. The test results demonstrate that the mechanical performance of the SOLANAS III™ Posterior Stabilization System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) SUMMARY
SOLANAS ™ Posterior Stabilization System 510(k) SUMMARY May 2007
AUG 2 0 2007
| Company: | Alphatec Spine, Inc.
2051 Palomar Airport Road#100
Carlsbad, CA 92011 USA
Telephone: (760) 431-9286
Fax: (760) 431-9132 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula Morgan, Director of Regulatory Affairs/Compliance |
| Trade/Proprietary Name: | SOLANAS ™ Posterior Stabilization System |
| Common Name: | Spinal Interlaminal Orthosis Fixation |
| Classification Name: | Spinal Interlaminal Orthosis Fixation (888.3050) |
| | Orthosis, Spinal Pedicle Fixation for Degenerative
Disc Disease (888.3070) |
Product Description:
The SOLANAS III™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
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
- l Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- 피 Spinal Stenosis
- 트 Fracture/Dislocation
- 트 Atlanto/Axial fracture with instability
page 1 of ?...
1
1071380
- 트 Revision of previous cervical spine surgery
- I Tumors
Substantial Equivalence:
The SOLANAS III™ Posterior Stabilization System is substantially equivalent to the following predicate devices:
Trade/Proprietary Name SOLANAS™ Posterior Stabilization System
Manufacturer Alphatec Spine, Inc. Clearance K052201
Performance Data:
Mechanical and dynamic testing of the posterior stabilization system was performed. The test results demonstrate that the mechanical performance of the SOLANAS III™ Posterior Stabilization System is substantially equivalent to the predicate devices.
page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2007
Alphatec Spine, Inc. % Ms. Paula Morgan Director of Regulatory Affairs & Compliance 2051 Palomar Airport Road, #100 Carlsbad, California 92011
Re: K071380
Trade/Device Name: SOLANASTM Posterior Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNI Dated: July, 30, 2007 Reccived: August 1, 2007
Dear Ms. Morgan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Paula Morgan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buchner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K071380
Device Name: SOLANAS TM Posterior Stabilization System
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
- l Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- 트 Spondylolisthesis
- . Spinal Stenosis
- 트 Fracture/Dislocation
- Atlanto/Axial fracture with instability
- 트 Revision of previous cervical spine surgery
- 트 Tumors
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
urrence of CDRH, Office of Device Evaluation (ODE)
Qarban Brielm Pfaixm
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
ge 1 of
510(k) Numbe