(132 days)
Not Found
No
The device description and intended use focus solely on the mechanical components and surgical application of spinal facet screws. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is intended for fixation to the lumbar spine to provide stability for fusion, treating conditions like degenerative disc disease, trauma, and spondylolisthesis, which are therapeutic interventions.
No
This device is a spinal facet screw system intended for fixation and stabilization of the lumbar spine, used in surgical treatment for various spinal conditions, and does not have a diagnostic function.
No
The device description clearly states the system consists of titanium alloy, cannulated bone screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The X-spine Zygafix Spinal Facet Screw System is a surgical implant designed for posterior fixation of the lumbar spine. It is a physical device implanted into the body to provide structural support and stability.
- Intended Use: The intended use is for surgical treatment of various spinal conditions by providing fixation and stability for fusion. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant, not a diagnostic tool used with in vitro specimens.
N/A
Intended Use / Indications for Use
The X-spine Systems, Inc. Zygafix™ 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 intended for use with only autogenous bone graft material. 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 Zygafix Spinal Facet Screw System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. The system consists of titanium alloy, cannulated bone screws that are available in various lengths and thread configurations to account for variations in patient anatomy. Each screw option contains axial fenestrations to allow the optional packing of bone graft. The screws are manufactured of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136.
This system is not to be used with bone cement. The safety and efficacy of using bone cement with this system has not been established.
The implant components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a Steam Autoclave in accordance with 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)
Biomechanical testing was performed using the following standards:
- ASTM F543 – Standard Specification and Test Methods for Metallic Bone Screws
- Annex 1 (A1) Test Method for Determining the Torsional Properties of Metallic Bone Screws
- Annex 2 (A2) Test Method for the Driving Torque of Medical Bone Screws
- Annex 3 (A3) - Test Method for Determining the Axial Pullout Strength of Medical Bone Screws
- Annex 4 (A4) Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws
- ASTM F2193 - Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- Annex 4 (A4) Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal Screws
Key results: Biomechanical testing results indicate that the Zygafix Spinal Facet Screw System is substantially equivalent to predicate device performance and is capable of safely and effectively 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
510(k) Summary
1 2013 MAY
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:
December 19, 2012
DEVICE NAME
| Trade/Proprietary Name: | Zygafix™ Spinal Facet Screw System |
|---|---|
| Common Name: | Facet Screw |
| Classification Name: | System, Facet Screw Spinal Device |
| Product Code: | MRW |
| Device Class: | Unclassified |
ESTABLISHMENT REGISTRATION NUMBER
The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/ operator number for X-spine Systems, Inc. is 9063903.
INTENDED USE
The X-spine Systems, Inc. Zygafix 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 intended for use with only autogenous bone graft material. 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,
1
- Trauma (i.e., fractures and/or dislocations), .
- Spondylolisthesis, .
- Spondylolysis, ●
- Pseudoarthrosis and/or failed previous fusions. .
DEVICE DESCRIPTION
The X-spine Zygafix Spinal Facet Screw System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. The system consists of titanium alloy, cannulated bone screws that are available in various lengths and thread configurations to account for variations in patient anatomy. Each screw option contains axial fenestrations to allow the optional packing of bone graft. The screws are manufactured of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136.
This system is not to be used with bone cement. The safety and efficacy of using bone cement with this system has not been established.
The implant components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a Steam Autoclave in accordance with 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 Zygafix Spinal Facet Screw System is substantially equivalent to the predicate device based on a comparison including the following characteristics:
- . FDA Product Code
- Intended Uses ●
- . Surgical Approach
- . Anatomical Region
- Implant Materials
- . Product Dimensions
- . Mechanical Performance
PREDICATE DEVICES
- X-spine Systems, Inc. Fixcet Spinal Facet Screw System (K100154) .
- SpineFrontier, Inc. Chameleon Fixation System (K071420) .
PERFORMANCE DATA
The implant components were tested using the following standards:
2
ASTM F543 – Standard Specification and Test Methods for Metallic Bone Screws
- Annex 1 (A1) Test Method for Determining the Torsional Properties of Metallic Bone . Screws
- Annex 2 (A2) Test Method for the Driving Torque of Medical Bone Screws .
- Annex 3 (A3) - Test Method for Determining the Axial Pullout Strength of Medical Bone Screws
- Annex 4 (A4) Test Method for Determining the Self-Tapping Performance of Self-Tapping . Medical Bone Screws
ASTM F2193 - Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- Annex 4 (A4) Test Method for Measuring the Static and Fatigue Bending Strength of . Metallic Spinal Screws
In conclusion, biomechanical testing results indicate that the Zygafix Spinal Facet Screw System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
3
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2013
X-Spine Systems, Incorporated % David Kirschman. M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K123932
Trade/Device Name: Zygafix™ Spinal Facet Screw System Regulatory Class: Unclassified Product Code: MRW Dated: March 27, 2013 Received: March 28, 2013
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K123932
Device Name: Zygafix™ Spinal Facet Screw System
Indications for Use:
The X-spine Systems, Inc. Zygafix 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 intended for use with only autogenous bone graft material. 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 | Over-The-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) X | (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 -S
(Division Sign-Off)
Division of Orthopedic Devices
510(k) Number: K123932