(62 days)
Not Found
No
The description focuses on mechanical components and materials, with no mention of AI/ML terms or functionalities.
Yes
The device is intended to treat various spinal instabilities and deformities, providing immobilization and stabilization as an adjunct to fusion, which are therapeutic actions.
No
The device is a spinal fixation system, intended to provide immobilization and stabilization, rather than diagnose a medical condition.
No
The device description clearly states it is a "posterior attachment pedicle fixation system" consisting of physical components like screws, rods, and connectors made of titanium, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural problems of the spine.
- Device Description: The description details components like "polyaxial screws, rods, cross connectors and interlocking mechanisms" made from titanium. These are physical implants designed to be surgically placed.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or components.
Therefore, the Lanx Spinal Fixation System 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; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Product codes
KWP, MNI
Device Description
The Lanx Spinal Fixation System is a posterior attachment pedicle fixation system. The system consists of a series of polyaxial screws, rods, cross connectors and interlocking mechanisms. The components are manufactured from alloyed titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
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)
Mechanical testing also demonstrated comparable mechanical properties to the predicate device.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
510(k) SUMMARY
Lanx Deformity System
AUG 1 5 2007
| Submitter Information | |
|---|---|
| Name and Address of Sponsor of the 510(k) Submission: | Lanx, LLC |
| 390 Interlocken Crescent, Suite 890 | |
| Broomfield, CO 80021 | |
| Contact Person: | Ryan Fredricey |
| Date of Summary Preparation: | June 13, 2007 |
| Device Identification | |
| Proprietary Name: | Lanx Spinal Fixation System |
| Common Name: | Spinal Fixation System |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis |
| 21 CFR §888.3050 |
Pedicle Screw Spinal System
21 CFR §888.3070 |
Predicate Device Information
K043484 Lanx Spinal Fixation System
Predicate Device Identification
The Lanx Spinal Fixation System is a posterior attachment pedicle fixation system. The system consists of a series of polyaxial screws, rods, cross connectors and interlocking mechanisms. The components are manufactured from alloyed titanium.
Description of Device Modification
This submission is intended to address a line extension to the Lanx Spinal Fixation System. The line extension includes additional pedicle screw sizes/configurations, hooks, connectors and the introduction of unalloyed titanium rods.
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
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1671633
(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).
Statement of Technological Comparison
The Lanx Deformity System has the same intended use and similar indications, principles of operation, and technological characteristics as the Lanx Spinal Fixation System. The minor differences in the line item extensions items do not raise any new questions of safety or effectiveness. Mechanical testing also demonstrated comparable mechanical properties to the predicate device.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2007
Lanx, LLC Janice M. Hogan % Hogan and Hartson, LLP 1835 Market Street, 28th Floor Philadelphia, PA 19102
K071633 Re:
Trade/Device Name: Lanx Deformity System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNI Dated: July 19, 2007 Received: July 19, 2007
Dear Ms. Hogan:
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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees mat have been 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 – Ms. Janice M. Hogan
This letter will allow you to begin marketing your device as described in your Section 510(k) 1 mm let notification. The FDA finding of substantial equivalence of your device to a legally prematted predicate device results in a classification for your device 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Noubara Buelup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_KO71633
Device Name: Lanx Spinal Fixation System
Indications for Use:
The Lanx Spinal Fixation System is intended to provide immobilization and I the Hans Opinal 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 (); ative evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Prescription Use _ X (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General. Restorative. and Neurological Devices
510(k) Number K071633
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