(150 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a spinal fixation system intended to provide immobilization and stabilization of spinal segments for treatment of various spinal conditions, which are therapeutic functions.
No
Explanation: The device is described as a "Spinal Fixation System" intended to provide "immobilization and stabilization of spinal segments" as an adjunct to fusion for treating various spinal instabilities and deformities. These are therapeutic functions, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description explicitly states it is a "posterior attachment pedicle fixation system" made up of "screws, rods, cross-links and interlocking mechanisms," 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. This testing is done outside of the body (in vitro).
- Lanx Spinal Fixation System: The description clearly states that this system is a "posterior attachment pedicle fixation system" intended for "immobilization and stabilization of spinal segments." It is a physical implant used within the body during surgery.
The intended use, device description, and lack of any mention of analyzing biological specimens all indicate that this is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Lanx Spinal Fixation System is 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; spinal tumor; and failed previous fusion (pseudarthrosis).
Product codes
MNI
Device Description
The Lanx Spinal Fixation System is a posterior attachment pedicle fixation system. The system is made up of a series of screws, rods, cross-links and interlocking mechanisms.
Materials: Titanium Alloy ASTM F136-92 ISO 5832-3
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1 vertebra
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)
Fatigue and static testing conducted in accordance with ASTM F-1717-01 are complete. The test results demonstrate that the device will perform in a manner substantially equivalent to available spinal fixation systems.
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
§ 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
MAY 1 6 2005
| 510(k) Summary Information
Premarket Notification, Section 510(k) | LANX, LLC.
MAY 11, 2005 |
|-----------------------------------------------------------------------|----------------------------|
| Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 | |
Regulatory Authority: Safe Medical L
Device Name: 1.
Lanx Spinal Fixation System Trade Name: Posterior lumbar spine system Common Name(s): Classification Name(s): Pedicle Screw Spinal System (888.3070)
Establishment Name & Registration Number: 2. Number: 3004485144 Name: LANX, LLC.
Equivalent Predicate Device: 3.
LANX, LLC. believes that the Lanx Spinal Fixation System is substantially equivalent to the following:
- Orthopedic Alliance, LLC, K033826, Orthopedic Alliance Spine System .
Equivalence can be seen in the design, material composition, surgical technique and intended use.
Device Description: 4.
The Lanx Spinal Fixation System is a posterior attachment pedicle fixation system. The system is made up of a series of screws, rods, cross-links and interlocking mechanisms.
Materials: Titanium Alloy ASTM F136-92 ISO 5832-3
Testing Summary: Fatigue and static testing conducted in accordance with ASTM F-1717-01 are complete. The test results demonstrate that the device will perform in a manner substantially equivalent to available spinal fixation systems.
ਨ Intended Use:
The Lanx Spinal Fixation System is 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; spinal tumor; and failed previous fusion (pseudarthrosis).
Applicant Name & Address: 6.
Lanx, LLC, 1155 Alpine Avenue, Suite 320, Boulder, CO 80304
7. Company Contact:
Michael Fulton, M.D., Lanx, LLC, 1155 Alpine Avenue, Suite 320, Boulder, CO 80304 Phone: 303-443-7500
8. Submission Correspondent:
Mr. David W. Schlerf, Buckman Company, Inc., 200 Gregory Lane, Suite C-100 Phone: 925.356.2640 - Fax:925.356.2654 david(@fda-help.com Pleasant Hill, CA 94523-3389
9. Performance Standards:
LANX, LLC. meets required general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
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1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or a stylized caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2005
Lanx, LLC C/o Mr. David W. Schlerf, V.P. Buckman Company Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389
Re: K043484
Trade/Device Name: Lanx Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI Dated: March 21, 2005 Received: March 23, 2005
Dear Mr. Schlerf:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regard child be of the Medical Device Americal Ford, Days commerce proof to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mail have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM alle Costlictic Act (71ct) that to noverceps of the general controls provisions of the Act. The You may, therefore, market the de resuirements for annual registration, listing of general controls provisions of the 110 libeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a00 roy ols. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oba' or reents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dris issualite over device complies with other requirements of the Act that I DA has made a actornmancis is as administered by other Federal agencies. You must of any Federal statutes and regarants and admitted to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTK in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Mr. David W. Schlerf, V.P.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to obgen mailing of substantial equivalence of your device to a legally premits that notification. "The PDF imaling of evice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do needed on our meeting of the regulation entitled, Contact the Office of Companies notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
tyt Rlurdu
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K043484 510(k) Number:
Lanx Spinal Fixation System Device Name(s):
Indications for Use(s) of the Device:
The Lanx Spinal Fixation System is intended to provide immobilization and The Lanx Spinal Fexation Bysten skeletally mature patients as an adjunct to Stabilization of spinal segments following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with (grades 5 and 4) of the LS BF (crosiment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Over-The-Counter Use _ OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Stipt Curdu
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Koy3484 510(k) Number_
(Optional format 1-2-96)
(Per 21 CFR 801.109)