(44 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or capabilities.
Yes
The device is intended to stabilize the spine as an aid to fusion and is indicated for the treatment of various degenerative and traumatic spinal conditions, which are therapeutic interventions.
No
The device is described as a system intended to stabilize the spine as an aid to fusion, comprising screws and instrumentation. Its purpose is mechanical support and immobilization, not the identification or diagnosis of a condition.
No
The device description explicitly details physical components made of surgical grade titanium alloy, including screws and instrumentation, which are hardware.
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 for stabilizing the spine as an aid to fusion through bilateral immobilization of the facet joints. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a system of screws and instrumentation made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is an implantable surgical device used inside the body.
N/A
Intended Use / Indications for Use
The ILLICO® FS Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. ILLICO® FS Facet Fixation System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1 inclusive. The facet fixation system is indicated for treatment of any or all of the following:
- degenerative disc disease (DDD) as defined by back pain of discogenic origins i confirmed by history and radiographic studies
- degenerative disease of the facets with instability
- trauma (i.e. fracture or dislocation)
- spondylolisthesis
- spondylolysis
- pseudoarthrosis and failed previous fusion which are symptomatic or which may ・ cause secondary instability or deformity
Product codes (comma separated list FDA assigned to the subject device)
MRW
Device Description
The ILLICO FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The system is comprised of the Facet Screw and Facet Lag Screw offered in two diameters (4.5mm and 5.0mm) and instrumentation. The implant provides bilateral facet fixation, with or without bone graft, at single or multiple levels and can be used in conventional or percutaneous surgical procedures. The implants are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back pain of discogenic origins, facet joints, L1-S1 inclusive
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 static and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed comparing the subject and predicate devices per the recognized consensus standards and per the guidance document, Guidance for Industry and FDA Staff: Spinal System 510(k)s (2004). The following testing was performed per ASTM F 543-07 and ASTM F 2193-02:
- . Torsion Yield Strength
- . Pull Out Force
- . Static Bending and Dynamic Testing
The above tests produced acceptable results and demonstrate that the ILLICO® FS Facet Fixation System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RaptorTM Facet Fixation System - K110170, Chameleon Fixation System - K071420
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
510(k) Summary
ILLICO® FS Facet Fixation System Date Prepared: July 20th, 2012
NOV 2 8 2012
| I | Company: | Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008.
USA |
|------|------------------------------|--------------------------------------------------------------------------------------------------|
| II. | Contact: | Trevor J. Denbo
Regulatory Affairs Specialist
Telephone: 760-494-6951
Fax: 760-431-0289 |
| III. | Product Name: | ILLICO® FS FACET FIXATION SYSTEM |
| IV. | Common Name: | Facet Screw Spinal Device |
| V. | Regulation Number: | None |
| VI. | Classification Product Code: | MRW |
| VII. | Predicate Devices: | RaptorTM Facet Fixation System - K110170
Chameleon Fixation System - K071420 |
VIII. Description:
The ILLICO FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The system is comprised of the Facet Screw and Facet Lag Screw offered in two diameters (4.5mm and 5.0mm) and instrumentation. The implant provides bilateral facet fixation, with or without bone graft, at single or multiple levels and can be used in conventional or percutaneous surgical procedures. The implants are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI).
IX. Indications for Use:
The ILLICO® FS Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. ILLICO® FS Facet Fixation System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1 inclusive. The facet fixation system is indicated for treatment of any or all of the following:
- degenerative disc disease (DDD) as defined by back pain of discogenic origins i confirmed by history and radiographic studies
- degenerative disease of the facets with instability ।
- trauma (i.e. fracture or dislocation) ।
- spondylolisthesis
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- spondylolysis
- pseudoarthrosis and failed previous fusion which are symptomatic or which may ・ cause secondary instability or deformity
X. Summary of the Technological Characteristics:
The technological characteristics, materials, and indications for use of the ILLICO® FS Facet Fixation System is substantially equivalent to the previously cleared predicates. The subject device differs from the predicates as follows:
- Addition of Facet Screws with diameters of 4.5mm and Facet Lag Screws with . diameters of 4.5mm and 5.0mm and a range of lengths for each.
- A minor dimensional change of the screw head and screw driver .
The facet screw is a dual lead self-tapping titanium screw with a positive (male) hexalobular drive feature. The spherical feature of the screw mates with the spherical surface of the washer allowing for angulations of the washer to accommodate differences in the anatomy between patients. The washer also distributes the compression force across a larger surface area, reducing the stress on the dorsal surface of inferior facet joint. The internal threads located in the hexalobular feature are used if axial force is needed during the removal of the screw. The ILLICO® FS Facet Fixation System thread profile is designed to the standard for cortical bone screws (ASTM F543-07). The thread is also a dual lead, which minimizes the number of rotations needed to implant the screw. The integral tapping flutes allow the screw to be placed without tapping prior to screw placement
XI. Discussion of the Non-clinical Testing:
Mechanical static and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed comparing the subject and predicate devices per the recognized consensus standards and per the guidance document, Guidance for Industry and FDA Staff: Spinal System 510(k)s (2004). The following testing was performed per ASTM F 543-07 and ASTM F 2193-02:
- . Torsion Yield Strength
- . Pull Out Force
- . Static Bending and Dynamic Testing
The above tests produced acceptable results and demonstrate that the ILLICO® FS Facet Fixation System is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion on the left. The eagle symbol is composed of three thick, curved lines that suggest the shape of a bird in flight. The text is in all caps and is arranged to follow the curve of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 28, 2012
Alphatec Spine, Incorporated % Mr. Trevor J. Denbo Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K123218
Trade/Device Name: ILLICO FS Facet Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: October 12, 2012 Received: October 31, 2012
Dear Mr. Denbo:
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 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 – Mr. Trevor J. Denbo
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/Medica!Devices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ronald P. Jean 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): K123218
Device Name: ILLICO FS Facet Fixation System
Indications For Use:
The ILLICO® FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The ILLICO FS System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1 inclusive. The ILLICO FS System is indicated for treatment of any or all of the following:
degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies
degenerative disease of the facets with instability l
trauma (i.e. fracture or dislocation) -
spondylolisthesis -
spondylolysis
pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity
Prescription Use ਮ (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)
Ronald P. Jean
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123218
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