← Product Code [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ) · K061353 # TRINICA ANTERIOR LUMBAR PLATE SYSTEM (K061353) _Zimmer Spine, Inc. · KWQ · Aug 30, 2006 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K061353 ## Device Facts - **Applicant:** Zimmer Spine, Inc. - **Product Code:** [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ.md) - **Decision Date:** Aug 30, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3060 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## 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 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. ## Device Story Trinica Anterior Lumbar Plate System is a temporary supplemental spinal fixation device; consists of titanium alloy plates and screws. Used for correction and stabilization of spine; augments spinal fusion; supplements interbody devices. Implanted via anterior, lateral, or anterolateral surgical approaches. Features anti-migration locking caps to secure fixation screws. Components are customizable to individual patient anatomy. Used by surgeons in clinical/OR settings to provide temporary stabilization for spinal instability. Benefits patient by facilitating solid spinal fusion and restoring spinal stability. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons. ## Technological Characteristics Materials: Titanium alloy (Ti-6Al-4V). Components: Plates, screws, and anti-migration locking caps. Design: Low-profile, anatomically contoured for anterior/lateral approaches. Mechanical fixation system. ## Regulatory 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. ## Predicate Devices - Synthes Anterior Tension Band (ATB) System - DePuy Spine AEGIS Anterior Lumbar Plate System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {1}------------------------------------------------ 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ ## 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K061353](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K061353) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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