(90 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components.
Yes
The device is a spinal fixation system intended to improve stability and treat conditions like degenerative disk disease, spondylolisthesis, and fractures, which directly alleviate or treat a disease or condition.
No
The device is a spinal fixation system intended to improve stability, not diagnose conditions. Its indications for use are for conditions confirmed by history and radiographic studies, implying diagnosis occurs separately.
No
The device description explicitly states it is a "spinal fixation system" with "implants" including "cervical hooks, polyaxial pedicle screws and rods," all made from "titanium alloy." This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for stabilizing the cervical and upper thoracic spine to treat various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a spinal fixation system made of titanium alloy, consisting of hooks, screws, and rods. These are physical implants used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Input Imaging Modality: While radiographic studies are mentioned, they are used to confirm the condition and likely to guide the placement of the implant, not as the primary input for a diagnostic test performed by the device itself.
- Performance Studies: The performance studies mentioned are mechanical testing, which is relevant for the structural integrity of a surgical implant, not for the analytical or clinical performance of a diagnostic test.
In summary, the SOLANAS™ Posterior Stabilization System is a surgical implant designed for spinal fixation, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use: It is intended that this device, in any system configuration, be removed after 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.
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- Degenerative disk disease (DDD), defined as neck pain of discogenic origin with deqeneration 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
KWP, MNI
Device Description
The SOLANAS™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and upper thoracic spine, C1-T3. There are a variety of implants that can be used for this procedure including cervical hooks, polyaxial pedicle screws and rods. All components are made from titanium alloy (ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical and upper thoracic spine, C1-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 testing of the SOLANAS™ Posterior Stabilization System was performed and submitted in this application.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Koszol.
SOLANAS™ Posterior Stabilization System 510(k) SUMMARY August 2005
NOV 1 0 2005
- Alphatec Spine, Inc. l. Company: 2051 Palomar Airport Road Suite 100 Carlsbad, CA 92011, USA (760) 431-9286
- Ellen Yarnall, Vice President of Compliance, ll Contact Person Regulatory Affairs and Quality Assurance
- SOLANAS™ Posterior Stabilization System ||| Trade/Proprietary Name:
IV Product Description:
The SOLANAS™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and upper thoracic spine, C1-T3. There are a variety of implants that can be used for this procedure including cervical hooks, polyaxial pedicle screws and rods. All components are made from titanium alloy (ASTM F136).
V. Classification
Pedicle Screw Spinal System KWP (21 CFR 888.3050) MNI (21 CFR 888.3070) Spinal Interlaminal Fixation Orthosis
VI Indications for Use
Indications for Use: It is intended that this device, in any system configuration, be removed after 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.
- Degenerative disk disease (DDD), defined as neck pain of discogenic origin with 1. 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 റ.
-
- Tumors
VII Substantial Equivalence:
The SOLANAS™ Posterior Stabilization System is substantially equivalent to Summit™ system (K002733).
VIII Performance Data:
Mechanical testing of the SOLANAS™ Posterior Stabilization System was performed and submitted in this application.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2005
Ellen A. Yarnall Vice President, RA/QA Alphatec Spine, Inc. 2051 Palomar Airport Road, Suite 100 Carlsbad, California 92011
Re: K052201
K052201
Trade/Device Name: SOLANAS™ Posterior Stabilization System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI Dated: October 27, 2005 Received: October 28, 2005
Dear Ms. Yarnall:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of the device is substantially equivalent (for the indications ferenced above und have acterimes ally marketed predicate devices marketed in interstate for use stated in the enclosure for regally manette to for the Medical Device Amendments, or to conninered proc to may 20, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 devices mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dierelore, mains 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 If your device 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 r rease of a rised that I termination 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.
2
Page 2-Ellen A. Yarnall
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): HOS 226)
Device Name: SOLANAS™ Posterior Stabilization System
Indications for Use:
Indications for Use: It is intended that this device, in any system configuration, be removed after 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.
-
- Degenerative disk disease (DDD), defined as neck pain of discogenic origin with deqeneration 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
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
ision of General, Restorative, no from ological Devices
) Number K052201
000012 Page 1 of 1 .