(101 days)
Not Found
No
The device description and intended use describe a mechanical spinal fixation system made of titanium alloy, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is a spinal fixation system indicated for the temporary stabilization of the human spine, which aligns with the definition of a therapeutic device.
No
This device is a spinal fixation device used for stabilization during fusion of the lumbar or lumbosacral spine, not for diagnosis.
No
The device description explicitly states that the system consists of a titanium alloy plate and bone screws, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a plate and screws) used for stabilizing the spine during fusion. This is a device that is physically implanted into the body for structural support and fixation.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely mechanical and structural.
Therefore, based on the provided information, the Biomet Anterior Lumbar Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Anterior Lumbar Plate System is an anterior or antereolateral spinal fixation device indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels in the fusion of the lumbar or lumbosacral spine at levels L1 through S1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of solid spinal fusions in patients with degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis, spondylovsis, spondylolisthesis, stenosis and/or failed previous fusion.
Product codes
KWQ
Device Description
The Biomet Anterior Lumbar Plate System consists of a titanium alloy plate and bone screws. The plates are available with two different lordotic curves for the lumbar or lumbosacral regions. Plates will be available in different lengths. The plates have threaded holes to accommodate bone screws, which will be available in different diameters and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar or lumbosacral spine at levels L1 through S1
Indicated Patient Age Range
Not Found
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)
Based upon the mechanical testing, the Biomet Anterior Lumbar Plate is substantially equivalent for its intended use to other spinal systems currently on the market.
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
§ 888.3060 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
Image /page/0/Picture/0 description: The image shows the text "Ko 82187" in a handwritten style. The characters are bold and slightly uneven, giving them a casual appearance. The text appears to be a code or identifier, possibly a serial number or a reference code.
Image /page/0/Picture/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with the letters connected to each other. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.
NOV 1 3 2008
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | November 11, 2008 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Vivian Kelly |
| Phone: 973-299-9300 x2214 | |
| Fax: 973-257-0232 | |
| Trade name: | Biomet Lumbar Plate System |
| Common Name: | Lumbar spinal fixation system |
| Classification Name -Product Code: | Spinal intervertebral body fixation orthosis - KWQ |
| Device Panel - Regulation No .: | Orthopedic - 21 CFR 888.3060 |
Device Description:
The Biomet Anterior Lumbar Plate System consists of a titanium alloy plate and bone screws. The plates are available with two different lordotic curves for the lumbar or lumbosacral regions. Plates will be available in different lengths. The plates have threaded holes to accommodate bone screws, which will be available in different diameters and lengths.
Indications for Use:
The Anterior Lumbar Plate System is an anterior or antereolateral spinal fixation device indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels in the fusion of the lumbar or lumbosacral spine at levels L1 through S1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of solid spinal fusions in patients with degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis, spondylovsis, spondylolisthesis, stenosis and/or failed previous fusion,
Summary of Technologies:
The Biomet Anterior Lumbar Plate System has similar technologics to the predicate devices.
Substantial Equivalence:
The Biomet Lumbar Plate is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness. Example of predicates include Synthes Anterior Tension Band (ATB) System (K022791), Zimmer Trinica® Anterior Lumbar Plate System (K061353) and EBI's Top Loading MAS Spinal Fixation System (K033312). Based upon the mechanical testing, the Biomet Anterior Lumbar Plate is substantially equivalent for its intended use to other spinal systems currently on the market.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2008
EBI, L.P. % Ms. Vivian Kelly, MS, RAC Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K082187
Trade/Device Name: Biomet Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: II Product Codc: KWQ Dated: November 03, 2008 Received: November 05, 2008
Dear Ms. Kelly:
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.
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.
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Page 2 - Ms. Vivian Kelly, MS, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 its 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.
Mark M. Milligan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use
510(k) Number (if known): K082187
Device Name: Biomet Anterior Lumbar Plate System
Indications for Use:
The Anterior Lumbar Plate System is an anterior or antereolateral spinal fixation device indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels in the fusion of the lumbar or lumbosacral spine at levels L1 through S1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of solid spinal fusions in patients with degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis, spondyloysis, spondylolisthesis, stenosis and/or failed previous fusion.
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)
Neil Rephle for axn
Page 1 of 1
(Division Division of General. Restorative, and Neurological Devices
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510(k) Number K082187