(210 days)
Not Found
No
The summary describes a mechanical plating system for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to provide fixation of the spine as an adjunct to fusion for treating various instabilities or deformities, such as degenerative disc disease, spinal stenosis, and trauma, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is a spinal fixation system, used to provide stability and support fusion, not to diagnose a medical condition.
No
The device description explicitly states that the system consists of "various plates and screws," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Lanx Anterior Plating System is described as a system of plates and screws used to provide fixation and stabilization of the spine during surgery. It is an implantable device used directly on the patient's anatomy.
- Intended Use: The intended use is to provide fixation as an adjunct to fusion in the treatment of various spinal instabilities and deformities. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided clearly indicates that this is a surgical implant used for structural support and stabilization within the body, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Lanx Anterior Plating System is intended to provide fixation of the thoracic, lumbar and/or sacral spine (T1-51) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the treatment of the following instabilities or deformities:
- Degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies);
- Spinal stenosis (indicated for L1- S1 only); .
- Spondylolisthesis; .
- Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); .
- Trauma (i.e., fracture, dislocation, or subluxation); .
- . Spondylolysis;
- Tumor; .
- . Pseudoarthrosis; and/or
- . Failed previous fusion.
The Lanx Anterior Plating System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.
Product codes
KWQ
Device Description
The Lanx Anterior Plating System consists of various plates and screws that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and/or sacral spine (T1-51)
Indicated Patient Age Range
skeletally mature patients
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)
Performance testing and engineering analysis were conducted to characterize the performance of the Lanx Anterior Plating System. The subject device was evaluated under ASTM F1717 construct testing for static axial compression, static torsion and dynamic axial compression testing versus a predicate device. 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)
K922543, K982875, K043548, K061229, K022791
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
-7 2010
510(k) SUMMARY
Lanx Anterior Plating 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: April 6, 2010
Name of Device
Lanx Anterior Plating System
Common or Usual Name
Spinal Fixation System
Classification
KWQ - 21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis
Predicate Device
Medtronic Sofamor Danek Z-Plate (K922543, K982875) Blackstone Medical Unity (K043548, K061229) Synthes ATB (K022791)
Intended Use / Indications for Use
The Lanx Anterior Plating System is intended to provide fixation of the thoracic, lumbar and/or sacral spine (T1-51) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the treatment of the following instabilities or deformities:
- Degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies);
- Spinal stenosis (indicated for L1- S1 only); .
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- Spondylolisthesis; .
- Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); .
- Trauma (i.e., fracture, dislocation, or subluxation); .
- . Spondylolysis;
- Tumor; .
- . Pseudoarthrosis; and/or
- . Failed previous fusion.
The Lanx Anterior Plating System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.
Device Description
The Lanx Anterior Plating System consists of various plates and screws that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.
Performance Data
Performance testing and engineering analysis were conducted to characterize the performance of the Lanx Anterior Plating System. The subject device was evaluated under ASTM F1717 construct testing for static axial compression, static torsion and dynamic axial compression testing versus a predicate device. The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices.
Substantial Equivalence
The Lanx Anterior Plating 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 Anterior Plating System is substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized image of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff entwined with snakes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 7 2010
Lanx, Inc. % Mr. Michael Funk 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021
Re: K092765
Trade/Device Name: Lanx Anterior Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 19, 2010 Received: March 23, 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, listing of devices, good manufacturing practice, labcling, 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
3
Page 2 - Mr. Michael Funk
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark A. Mulkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K092765
Device Name: Lanx Anterior Plating System
Indications for Use:
The Lanx Anterior Plating System is intended to provide fixation of the thoracic, lumbar and/or sacral spine (T1-51) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the treatment of the following instabilities or deformities:
- Degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies);
- Spinal stenosis (indicated for L1-S1 only); .
- . Spondylolisthesis;
- Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); .
- . Trauma (i.e., fracture, dislocation, or subluxation);
- Spondylolysis; .
- . Tumor;
- Pseudoarthrosis; and/or .
- ♥ Failed previous fusion.
The Lanx Anterior Plating System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.
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)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092765