(121 days)
Not Found
No
The device description and intended use are solely focused on a mechanical spinal facet screw system and do not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for posterior fixation to the lumbar spine, specifically for fusion and stability to treat various spinal conditions like degenerative disc disease, trauma, and spondylolisthesis, which aims to provide a medical benefit to patients.
No
The device is a spinal facet screw system intended for posterior fixation and stabilization of the lumbar spine for fusion, not for diagnosing medical conditions.
No
The device description clearly states that the system consists of titanium alloy bone screws, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the X-spine Fixcet Spinal Facet Screw system is an implantable device intended for posterior fixation to the lumbar spine. It is a physical screw system used in surgery to stabilize the spine.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition through testing of bodily fluids or tissues.
The device is a surgical implant used for structural support and stabilization, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The X-spine Systems, Inc. Fixcet Spinal Facet Screw system is intended for posterior fixation to the lumbar spine (L1 to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system.is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc . as confirmed by patient history and radiographic studies),
- . Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
- . Trauma (i.e., fractures and/or dislocations),
- . Spondylolisthesis,
- . Spondylolysis,
- . Pseudoarthrosis and/or failed previous fusions.
Product codes (comma separated list FDA assigned to the subject device)
MRW
Device Description
The X-spine Fixcet Spinal Facet Screw System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. This system consists of titanium alloy bone screws designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. The self-tapping 4.5mm diameter facet screws are available in two configurations: (1) single-threaded screws offered in lengths of 25-45mm (in 5 mm increments); and (2) dual-threaded screws offered in lengths of 30-45mm (in 5 mm increments). The screws are composed of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F-136.
The implant components are provided clean and non-sterilized by a healthcare professional using Steam Autoclave in accordance to the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the Autoclave.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L1 to 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)
The implant components were tested using the following standards:
ASTM F2193 – Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- Static Compression Bending .
- Fatigue Compression Bending .
ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws - . Torsional Yield Strength
- . Insertion Torque
- Removal Torque .
- . Pullout Force
- Self-Tapping Performance
In conclusion, biomechanical testing results indicate that the Fixcet Spinal Facet Screw System is substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use.
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.
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
100154
MAY 2 1 2010
510(k) SUMMARY
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | X-spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg, OH 45342 |
|-------------------------|--------------------------------------------------------------------------|
| | Telephone (937) 847-8400
FAX (937) 847-8410 |
| Official Contact: | David Kirschman, M.D.
Chief Medical Officer |
| Date Prepared: | January 15, 2010 (revised April 21, 2010) |
| DEVICE NAME | |
| Trade/Proprietary Name: | Fixcet™ Spinal Facet Screw System |
| Classification Name: | System, Facet Screw Spinal Device |
| Common Name: | Facet Screw |
ESTABLISHMENT REGISTRATION NUMBER
X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.
DEVICE CLASSIFICATION
FDA has classified facet screw spinal devices as Unclassified. The product code for System, Facet Screw Spinal Device is MRW. These device classifications are reviewed by the Orthopedic Devices Branch.
INTENDED USE
The X-spine Systems, Inc. Fixcet Spinal Facet Screw system is intended for posterior fixation to the lumbar spine (L1 to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system.is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:
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1
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc . as confirmed by patient history and radiographic studies),
- . Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
- . Trauma (i.e., fractures and/or dislocations),
- . Spondylolisthesis,
- . Spondylolysis,
- . Pseudoarthrosis and/or failed previous fusions.
DEVICE DESCRIPTION
The X-spine Fixcet Spinal Facet Screw System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. This system consists of titanium alloy bone screws designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. The self-tapping 4.5mm diameter facet screws are available in two configurations: (1) single-threaded screws offered in lengths of 25-45mm (in 5 mm increments); and (2) dual-threaded screws offered in lengths of 30-45mm (in 5 mm increments). The screws are composed of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F-136.
The implant components are provided clean and non-sterilized by a healthcare professional using Steam Autoclave in accordance to the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the Autoclave.
EQUIVALENCE TO MARKETED PRODUCT
X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Fixcet Spinal Facet Screw system is substantially equivalent to the Depuy Spine Discovery System (K012773) and the SpineFrontier Chameleon System (K071420) based on a comparison of the following:
- . FDA Product Code
- . Intended Uses
- Surgical Approach ●
- . Levels of Fixation
- Implant Materials .
- � Product Dimensions
- . Mechanical Performance
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2
PERFORMANCE DATA
The implant components were tested using the following standards:
ASTM F2193 – Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- Static Compression Bending .
- Fatigue Compression Bending .
ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws
- . Torsional Yield Strength
- . Insertion Torque
- Removal Torque .
- . Pullout Force
- � Self-Tapping Performance
In conclusion, biomechanical testing results indicate that the Fixcet Spinal Facet Screw System is substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use.
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3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings and a flowing design below, possibly representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MAY 2 1 2010
X-Spine Systems, Inc. % David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K100154
Trade/Device Name: Fixcet™ Spinal Facet Screw System Regulation Number: Unclassified Product Code: MRW Dated: April 21, 2010 Received: May 19, 2010
Dear Dr. Kirschman:
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. Iisting 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.
4
Page 2 - David Kirschman, M.D.
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.
Soubare buchanD
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K100154
Device Name: Fixcet™ Spinal Facet Screw System
Indications for Use:
The X-spine Systems, Inc. Fixcet Spinal Facet Screw System is intended for posterior fixation to the lumbar spine (L1 to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:
- . Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
- Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral . radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
- . Trauma (i.e., fractures and/or dislocations),
- . Spondylolisthesis,
- . Spondylolysis,
- . Pseudoarthrosis and/or failed previous fusions.
Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)
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)
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ K100154
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