(94 days)
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.
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).
The provided text describes a 510(k) premarket notification for the Lanx Facet Screw System and not a study assessing the performance of a device against acceptance criteria in the context of AI or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical testing.
Therefore, many of the requested categories are not applicable to this document. I will fill in the available information and indicate where data is not present or relevant for this type of submission.
Acceptance Criteria and Device Performance Study for Lanx Facet Screw System
This 510(k) submission for the Lanx Facet Screw System focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific clinical performance acceptance criteria for diagnostic accuracy or AI-assisted decision-making. The "performance data" presented relates to mechanical testing to ensure the device is physically robust and comparable to existing, legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated as Numerical Targets) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | - Ability to withstand dynamic and static three-point bend (per ASTM F1264-03). - Ability to withstand cantilever bend (per ASTM F2193). - Ability to withstand torsion. - Ability to withstand axial pull-out (per ASTM F543). - Comparable mechanical properties to predicate devices (NuVasive Facet Screw and Globus Corridor Fixation 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." - Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices. |
| Intended Use/Indications | - Stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. - Used from C2 to S1 (for 3.5mm and 4.0mm screws) and L1 to S1 (for 4.5mm screws). - Indicated for conditions such as pseudoarthrosis, spondylolisthesis, DDD, degeneration of facets with instability, and trauma. | - The 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. - The system is indicated for the specified conditions. |
| Material Composition | - Fabricated from medical grade titanium alloy. | - Implants are fabricated from medical grade titanium alloy (per ASTM F-136). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This is a mechanical testing submission, not a clinical study involving patients. The "test set" refers to the number of screws and components subjected to mechanical testing. The document does not specify the exact number of units tested for each mechanical test, but references standard ASTM methods which typically define sample size requirements.
- Data Provenance: The data originates from laboratory mechanical testing and engineering analysis conducted by Lanx, Inc. (the manufacturer). It is not patient or clinical data, retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a mechanical testing submission for substantial equivalence. "Ground truth" in the diagnostic or AI context (e.g., expert consensus on medical images or pathology) is not relevant here. The "truth" is established by adherence to ASTM standards and engineering principles for mechanical performance.
4. Adjudication Method for the Test Set
- Not Applicable. As this is mechanical testing, there is no "adjudication" in the sense of reconciling divergent expert opinions or labeling for diagnostic accuracy. The performance is objectively measured against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This document describes a medical device (surgical implant) and its mechanical performance evaluation for substantial equivalence, not a diagnostic device or AI system. Therefore, MRMC studies improving human reader performance with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm or software device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Engineering Standards: The "ground truth" or reference for evaluating the device's performance is adherence to established ASTM mechanical testing standards (e.g., ASTM F1264-03, ASTM F2193, ASTM F543) and engineering principles, demonstrating comparable mechanical properties to predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI system that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, no training set is involved.
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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
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| 510(k) Number | K101364 |
|---|---|
| --------------- | --------- |
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