(85 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as promoting fusion of the cervical spine and providing stabilization during bone graft healing and/or fusion mass development, which are therapeutic actions.
No
The provided text describes a spinal fixation system intended to promote fusion and provide stabilization. It does not mention any diagnostic capabilities or functions.
No
The device description explicitly states it is a spinal fixation system consisting of non-sterile, single-use plates and screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Posterior Fixation System" intended to "promote fusion of the cervical spine and the occipito-cervico-thoracic junction." This describes a surgical implant used in vivo (within the body) to provide structural support and stabilization.
- Device Description: The device is described as a "spinal fixation system that consists of a variety of non-sterile, single-use plates and screws." These are physical implants.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided description does not mention any such use or components.
Therefore, the Solanas Avalon Posterior Fixation System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The SOLANAS AVALON Posterior Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). It is intended that this device, in any system configuration, be removed after development of solid fusion mass. The occipital bone screws are limited to occipital fixation only. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws are intended for placement only in T1-T3 for anchoring of the system. These screws and offset connectors are not intended to be placed in the cervical spine. The components in the Solanas Posterior Fixation 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. However, the components of the SOLANAS AVALON Posterior Fixation System are not intended to work with the Zodiac System.
It is intended for the following:
- 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
- Occipito-cervical dislocation
Product codes
NKB, MNI, KWP
Device Description
The Solanas Avalon Posterior Fixation System is a spinal fixation system that consists of a variety of non-sterile, single-use plates and screws. All implants are manufactured from titanium alloy conforming to ASTM F136 or commercially pure titanium conforming to ASTM F67. The system also contains Class I manual instruments. The implants provide stabilization during bone graft healing and/or fusion mass development.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and the occipito-cervico-thoracic junction (occiput-T3), Occipital bone, C1-C7, T1-T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The in-vitro mechanical testing was performed per ASTM 2706-08 for axial compression, dynamic compression, static torsion, and dynamic torsion testing of occipital fusion devices. The test results demonstrate that the mechanical performance of the Solanas Avalon Posterior Fixation 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.
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page 1 of 2
JUL 1 2 2011
510(k) SUMMARY June 2011
| Submitter: | Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008
Direct: (760) 494-6942
Fax: (760) 431-0289 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Joyce Vu, RAC, Director Regulatory Affairs |
| Trade/Model Name: | Solanas Avalon Posterior Fixation System |
| Common Name: | Rod and Screw Spinal Instrumentation |
| Classification Regulation: | Spinal Interlaminal Fixation Orthosis |
Device Description:
The Solanas Avalon Posterior Fixation System is a spinal fixation system that consists of a variety of non-sterile, single-use plates and screws. All implants are manufactured from titanium alloy conforming to ASTM F136 or commercially pure titanium conforming to ASTM F67. The system also contains Class I manual instruments. The implants provide stabilization during bone graft healing and/or fusion mass development.
Substantial Equivalence:
The Solanas Avalon Posterior Fixation System is substantially equivalent to the following predicate devices:
| System | Clearance | Company |
|---|---|---|
| Vertex Reconstruction System | K093434 | Medtronic |
| Ascent POCT System | K080394 | Blackstone Medical |
| Solanas Posterior Stabilization | K071380 | Alphatec Spine |
Intended Use
The SOLANAS AVALON Posterior Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). It is intended that this device, in any system configuration, be removed after development of solid fusion mass. The occipital bone screws are limited to occipital fixation only. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws are intended for placement only in T1-T3 for anchoring of the system. These screws and offset connectors are not intended to be placed in the cervical spine. The components in the Solanas Posterior Fixation System can be linked to the components in the Zodiac Polyaxial spinal fixation system offered by Alphatec Spine using the axial rod connectors, parallel
1
K111076 page 2 of 2
rod connectors or transitional rods. However, the components of the SOLANAS AVALON Posterior Fixation System are not intended to work with the Zodiac System.
It is intended for the following:
- Degenerative disc 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
- న. Atlanto/Axial fracture with instability
- Revision of previous cervical spine surgery 6.
-
- Tumors
- Occipito-cervical dislocation 8.
Technological Characteristics Comparison:
The Solanas Avalon Posterior Fixation System is equivalent to the predicate devices in that it is intended to be used to provide temporary internal occipito-cervico-thoracic spine fixation and stabilization during bone graft healing and/or fusion mass development. It is similar in terms of general design, intended use, and technological characteristics to the predicate device. Material composition is identical to numerous other Alphatec Spine products that have been cleared via the 510(k) process.
Nonclinical Performance Data:
The in-vitro mechanical testing was performed per ASTM 2706-08 for axial compression, dynamic compression, static torsion, and dynamic torsion testing of occipital fusion devices. The test results demonstrate that the mechanical performance of the Solanas Avalon Posterior Fixation System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above three wavy lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 2 2011
Alphatec Spine, Inc. % Ms. Karla Schaffner Regulatory Affairs Submissions Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K111076
Trade Name: Solanas Avalon Posterior Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, KWP Dated: June 16, 2011 Received: June 17, 2011
Dear Ms. Schaffner,
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
3
Page 2 – Ms. Karla Schaffner
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
E. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 11 Indications for Use Statement
510(k) Number (if known): K111076
Device Name: Solanas® Avalon™ Posterior Fixation System
Indications for Use:
The SOLANAS A VALON Posterior Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). It is intended that this device, in any system the occipito-corviol after development of solid fusion mass. The occipital bone screws are limited to comiguration, be removed and components are indicated for use at CI-C7. Polyaxial pedicle screws are occipital fixation only - Trook oomponono are the system. These screws and offset connectors are million of placed in the cervical spine. The components in the Solanas Posterior Fixation System not melled 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. However, the components of the using the axial roa connecters, parkation System are not intended to work with the Zodiac System.
It is intended for the following:
- Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the l. disc confirmed by history and radiographic studies.
- Spondylolisthesis. 2.
-
- Spinal stenosis.
- Fracture/Dislocation. 4.
- Atlanto/Axial fracture with instability. న్న
- Revision of previous cervical spine surgery. 6.
-
- Tumors.
- Occipito-cervical dislocation. 8.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The Counter Use --------
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Dwision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIII676 510(k) Number_