(107 days)
The Trinica Anterior Lumbar Plate System is 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. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instabliity as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.
The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6Al-4V).
This document describes a 510(k) summary for the Zimmer Spine Trinica Anterior Lumbar Plate System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results as one might find for a novel AI/software medical device.
Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable or cannot be extracted from this specific document.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Claim)
This 510(k) submission does not establish or report performance against specific quantitative acceptance criteria for a novel device. Instead, it claims substantial equivalence to existing predicate devices. The "acceptance criteria" in this context are implicitly that the device's technological characteristics and intended use are similar enough to existing legally marketed devices, such as the Synthes Anterior Tension Band (ATB) System and DePuy Spine AEGIS Anterior Lumbar Plate System.
The "device performance" is therefore not demonstrated through a study with outcome metrics but rather by stating that its characteristics (materials, range of sizes, intended use) are similar to the predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Substantial Equivalence: Device must have the same technological characteristics (materials, sizes, intended use) as predicate devices. | "The Zimmer Spine Trinica Anterior Lumbar Plate System shares the same technological characteristics as the Synthes Anterior Tension Band (ATB) System and the Depuy Spine's AEGIS Anterior Lumbar Plate System. These characteristic include materials, range of sizes, and intended use." "The Zimmer Spine Trinica Anterior Lumbar Plate System is substantially equivalent to the Synthes Anterior (ATB) System and the Depuy Spine's AEGIS Anterior Lumbar Plate System in design, materials, function and intended use." |
Detailed information based on the request, where applicable:
-
A table of acceptance criteria and the reported device performance:
- Refer to the table above. The acceptance criteria are implicitly met by demonstrating technological equivalence to predicate devices, rather than through specific performance metrics.
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Sample size used for the test set and the data provenance:
- N/A. This document does not describe a clinical trial or performance study with a test set of data. It is a 510(k) submission based on technological comparison.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No test set or ground truth establishment by experts is described as this is a device based on mechanical design and materials, not an AI/diagnostic device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set with adjudication is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a hardware medical device (spinal implant), not an AI/software device. MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware device; "standalone algorithm performance" is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. For this type of device, ground truth would typically relate to mechanical testing standards or clinical outcomes from previous studies of similar devices, none of which are detailed in this 510(k) summary provided. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
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The sample size for the training set:
- N/A. Not applicable for a hardware medical device submission of this nature.
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How the ground truth for the training set was established:
- N/A. Not applicable for a hardware medical device submission of this nature.
Summary of the K061353 Filing:
The Zimmer Spine Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device for the spine. The 510(k) submission (K061353) asserts its substantial equivalence to two predicate devices: the Synthes Anterior Tension Band (ATB) System and the DePuy Spine AEGIS Anterior Lumbar Plate System. The basis for this claim is the similarity in design, materials (Titanium alloy Ti-6Al-4V), functional aspects ("locked into a variety of configurations," "anti-migration locking caps"), range of sizes, and intended use as a spinal fixation system to treat L1-S1 instability resulting from conditions like fracture, tumor, degenerative disc disease, etc. The FDA's review led to a determination of substantial equivalence, allowing the device to be marketed. This type of submission relies on demonstrating that the new device does not raise new questions of safety and effectiveness compared to a legally marketed predicate.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Spine. The logo consists of a circle with a stylized "Z" inside it, above the words "zimmer" and "spine", with "spine" underlined. The text is in a sans-serif font, and the logo is in black and white.
AUG 3 0 2006
061353
Pa lof 2
510(k) Summary
Submitter:
...
Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439
Company Contact:
Tim Crabtree Senior Regulatory Affairs Specialist
Date Prepared: May 12, 2006
Trinica® Anterior Lumbar Plate System Device Name:
Common Name: Spinal Fixation System
Classification Name: Spinal intervertebral body fixation orthosis
Classification: 21 CFR §888.3060
Product Code: KWQ
- Predicate Devices: Synthes Anterior Tension Band (ATB) System DePuy Spine AEGIS Anterior Lumbar Plate System
Description of Device: The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6Al-4V).
Intended Use: The Trinica Anterior Lumbar Plate System is 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. This system is indicated in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined
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061353 9 20F 2
as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.
Comparison of Technological Characteristics: The Zimmer Spine Trinica Anterior Lumbar Plate System shares the same technological characteristics as the Synthes Anterior Tension Band (ATB) System and the Depuy Spine's AEGIS Anterior Lumbar Plate System. These characteristic include materials, range of sizes, and intended use.
Substantial Equivalence: The Zimmer Spine Trinica Anterior Lumbar Plate System is substantially equivalent to the Synthes Anterior (ATB) System and the Depuy Spine's AEGIS Anterior Lumbar Plate System in design, materials, function and intended use.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
AUG 3 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer Spine, Inc. % Mr. Tim Crabtree Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K061353
Trade Name: Trinica® Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 22, 2006 Received: August 25, 2006
Dear Mr. Crabtree:
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 - Mr. Tim Crabtree
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 Office of Compliance at (240) 276- 0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Barbara Preem
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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KO61353
Indications for Use Statement
510(k) Number (if known):
Device Name: Trinica® Anterior Lumbar Plate System
Indications for Use: The Trinica Anterior Lumbar Plate System is 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. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instabliity as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.
× Prescription Use Over-The-Counter Use AND/OR (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)
Barbara Buchum
Division of General, Restorative. and Neurological Devices
, Page 6 of 31 510(k) Number_K
§ 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.