(94 days)
Not Found
No
The description focuses on the mechanical components and materials of a spinal implant system, with no mention of AI or ML capabilities.
Yes
The device is intended to stabilize the spine as an aid to fusion and is indicated for the treatment of various spinal conditions, directly providing a therapeutic effect.
No
The device, a facet screw system, is intended to stabilize the spine as an aid to fusion and is used for treatment, not for diagnosing conditions.
No
The device description explicitly states that the system consists of "various screws and washers" fabricated from "medical grade titanium alloy," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of screws and washers made from medical grade titanium alloy. These are physical implants used in surgery.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Lanx Facet Screw System is indicated for treatment of any or all of the following:
- pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
- spondylolisthesis;
- spondylolysis;
- degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
- degeneration of the facets with instability and; ●
- trauma including spinal fractures and/or dislocations.
Product codes
MRW
Device Description
The Lanx Facet Screw System consists of various screws and washers designed to compact juxtaposed facet articular processes to enhance spinal fusion and stability. The screws are available partially threaded or fully threaded, cannulated or non-cannulated, and in various diameters and lengths to accommodate patient anatomy. Lanx Facet Screw System implants are fabricated from medical grade titanium alloy (per ASTM F-136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to S1, L1 to S1
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)
Performance testing and engineering analysis were conducted to characterize the performance of the Lanx Facet Screw System. Testing performed included dynamic and static three-point bend per ASTM F1264-03, cantilever bend per ASTM F2193, torsion and axial pull-out testing per ASTM F543. The device functioned as intended and the observed test results demonstrate substantial equivalence 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
N/A
0
510(k) SUMMARY
Lanx Facet Screw System
Name of Firm and Contact
Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021 Phone: 303-443-7500 Contact Person: Michael Funk Date Prepared: May 13, 2010
AUG 1 6 2010
Name of Device
Lanx Facet Screw System
Common or Usual Name
Facet Screw System
Classification
Unclassified, Product Code - MRW
Predicate Device
NuVasive Facet Screw (K020411, K001323) Globus Corridor Fixation System (K083442)
Intended Use / Indications for Use
The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Lanx Facet Screw System is indicated for treatment of any or all of the following:
- pseudoarthrosis and failed previous fusions which are symptomatic or which may cause . secondary instability or deformity;
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- spondylolisthesis; .
- spondylolysis;
- degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic . origin as confirmed by radiographic studies;
- degeneration of the facets with instability and; ●
- . trauma including spinal fractures and/or dislocations.
Device Description
The Lanx Facet Screw System consists of various screws and washers designed to compact juxtaposed facet articular processes to enhance spinal fusion and stability. The screws are available partially threaded or fully threaded, cannulated or non-cannulated, and in various diameters and lengths to accommodate patient anatomy. Lanx Facet Screw System implants are fabricated from medical grade titanium alloy (per ASTM F-136).
Performance Data
Performance testing and engineering analysis were conducted to characterize the performance of the Lanx Facet Screw System. Testing performed included dynamic and static three-point bend per ASTM F1264-03, cantilever bend per ASTM F2193, torsion and axial pull-out testing per ASTM F543. The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices.
Substantial Equivalence
The Lanx Facet Screw System has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate systems. Equivalency of this device is based on similarities in intended use, materials and design. Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices. Thus, the Lanx Facet Screw System is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wings and tail. The eagle is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lanx, Inc. % Mr. Michael Funk Director of Engineering, Lumbar 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021
Re: K101364
Trade/Device Name: Lanx Facet Screw System Regulatory Class: Unclassified Product Code: MR W Dated: May 13, 2010 Received: May 19, 2010
Dear Mr. Funk:
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.
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
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Page 2 - Mr. Michael Funk
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 yours,
Qaulage Bneem
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K101364
Device Name: Lanx Facet Screw System
Indications for Use:
The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Lanx Facet Screw System is indicated for treatment of any or all of the following:
- pseudoarthrosis and failed previous fusions which are symptomatic or which may cause � secondary instability or deformity;
- . spondylolisthesis;
- spondylolysis;
- degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic ● origin as confirmed by radiographic studies:
- . degeneration of the facets with instability and;
- trauma including spinal fractures and/or dislocations. .
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
| 510(k) Number | K101364 |
|---|---|
| --------------- | --------- |
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