(28 days)
Not Found
No
The device description focuses on mechanical components for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are non-clinical mechanical tests.
Yes
This device is intended to promote fusion of the spine and provide supplemental stabilization of spinal segments, which are therapeutic functions.
No
The device description clearly states that the Lanx Posterior Cervicothoracic Spinal Fixation System consists of various components used to build a construct that provides "supplemental stabilization of spinal segments to support fusion." This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states it consists of various physical components like screws, hooks, plates, rods, and connectors made from titanium and cobalt chrome alloys, which are hardware implants.
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, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Lanx Posterior Cervicothoracic Spinal Fixation System consists of "various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion." These are physical implants used within the body.
- Intended Use: The intended use is to "promote fusion of the occipito-cervico-thoracic region of the spine" and address various spinal conditions. This is a surgical intervention, not a diagnostic test performed on samples.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:
- Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- . Spondylolisthesis
- Spinal Stenosis ♥
- . Trauma/Fracture/Dislocation
- Atlanto-Axial Fracture with Instability .
- Occipito-Cervical Dislocation .
- . Failed Previous Fusion
- . Tumor
The use of occipital bone screws is limited to placement in the occiput only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-73) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, KWP
Device Description
The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, plates, rods, connectors, etc. 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, with the anchors and connectors rigidly locked to the rod, allowing the surgeon to tailor the construct to the particular needs of the patient.
The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy per ASTM F136 and cobalt chrome alloy per ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
occipito-cervico-thoracic region of the spine (occiput-T3)
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)
Non-clinical performance testing was conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System. Static and dynamic axial compression bending construct testing was performed in accordance ASTM F1717 on the modified and predicate systems, and the results compared. The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device.
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.
K103040, K100888, K100191, K092656, K071905
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
DEC 1 9 2011
510(k) SUMMARY
Lanx Posterior Cervicothoracic Spinal Fixation System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Lanx, Inc. 310 Interlocken Parkway, Suite 120 Broomfield, CO 80021
Phone: 303-443-7500 Facsimile: 303-443-7501
Contact Person: Michael Funk Date Prepared: December 19, 2011
Name of Device and Name/Address of Sponsor
Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)
Lanx, Inc. 310 Interlocken Parkway, Suite 120 Broomfield, CO 80021
Common or Usual Name
Spinal Fixation System
Classification Name/Device Class
NKB, MNI - 21 CFR 888.3070 - Pedicle Screw Spinal System KWP - 21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis Class II and Class III
Predicate Device(s)
Lanx PCFS K103040, K100888, K100191, K092656, K071905
Intended Use / Indications for Use
When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:
- Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- . Spondylolisthesis
Page 1 of 2
1
- Spinal Stenosis ♥
- . Trauma/Fracture/Dislocation
- Atlanto-Axial Fracture with Instability .
- Occipito-Cervical Dislocation .
- . Failed Previous Fusion
- . Tumor
The use of occipital bone screws is limited to placement in the occiput only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-73) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Technological Characteristics
The purpose of this 510(k) submission is to add modified hooks of various configurations to the Lanx Posterior Cervicothoracic Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, plates, rods, connectors, etc. 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, with the anchors and connectors rigidly locked to the rod, allowing the surgeon to tailor the construct to the particular needs of the patient.
The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy per ASTM F136 and cobalt chrome alloy per ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.
Performance Data
Non-clinical performance testing was conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System. Static and dynamic axial compression bending construct testing was performed in accordance ASTM F1717 on the modified and predicate systems, and the results compared. The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device.
Substantial Equivalence
The modified Lanx Posterior Cervicothoracic Spinal Fixation System has the same intended use, indications, technological characteristics, and principles of operation as the predicate system. The modifications to the Lanx Posterior Cervicothoracic Spinal Fixation System do not raise new issues of safety or effectiveness. Mechanical testing demonstrated comparable mechanical properties to the predicate device. Thus, the modified Lanx Posterior Cervicothoracic Spinal Fixation System is substantially equivalent to the predicate device.
page 2 of 2
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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 lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 9 2011
Lanx, Inc. % Mr. Michael Funk 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021
Re: K113434
Trade/Device Name: Lanx Posterior Cervicothoracic Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, KWP Dated: November 18, 2011 Received: November 25, 2011
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, 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
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Page 2 - Mr. Michael Funk
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 (OS) 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,
Sincerely yours,
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 (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Lanx Posterior Cervicothoracic Spinal Fixation System
Indications for Use:
When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:
- Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Spinal Stenosis .
- . Trauma/Fracture/Dislocation
- Atlanto-Axial Fracture with Instability .
- Occipito-Cervical Dislocation .
- Failed Previous Fusion .
- . Tumor
The use of occipital bone screws is limited to placement in the occiput only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
| Prescription Use X | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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, Orthopedie, and Restorative Devices
Page | of |
K 1134 34 510(k) Number.
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