← Product Code [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ) · K063430 # ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM (K063430) _Stryker Spine · KWQ · Mar 22, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K063430 ## Device Facts - **Applicant:** Stryker Spine - **Product Code:** [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ.md) - **Decision Date:** Mar 22, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3060 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Zero Profile Anterior Cervical Plating (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: - Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - Trauma (including fractures) - Tumors - Deformities or curvatures (including kyphosis, lordosis, or scoliosis) - Pseudarthrosis - Failed previous fusion - Decompression of the spinal cord following total or partial cervical vertebrectomy - Spondylolisthesis - Spinal stenosis WARNING: This device is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. ## Device Story Zero Profile ACP System provides anterior cervical spine stabilization; intended for use with Reflex Hybrid ACP bone screws. System consists of one-level and two-level plates (12mm-42mm lengths). Surgeon implants device during cervical fusion procedures to provide temporary fixation. Lower profile design compared to predicate Reflex Hybrid ACP plates; maintains identical material composition and intended use. Device supports spinal fusion by stabilizing vertebral segments. ## Clinical Evidence No clinical data. Substantial equivalence supported by engineering analysis and performance testing. ## Technological Characteristics Materials: Ti6Al4V alloy per ASTM F-136. Configuration: One-level and two-level anterior cervical plates, 12mm-42mm lengths. Fixation: Uses predicate Reflex Hybrid ACP bone screws. Sterilization: Provided non-sterile. ## 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 - Reflex™ Hybrid ACP System ([K062310](/device/K062310.md), [K040261](/device/K040261.md)) - Synthes Cervical Spine Locking Plate System ([K000536](/device/K000536.md) and [K000742](/device/K000742.md)) ## 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}------------------------------------------------ Line Extension to the Stryker Spine Reflex ™ Hybrid ACP System ## Special 510(k) Summary: Special 510(k) Sv.mary: Zero Profile Anterior Cervical Plate System, MAR 2 2 2007 Line Extension to the Stryker Spine Reflex™ Hybrid ACP System | Proprietary Name: | Zero Profile Anterior Cervical Plate (ACP) System | |----------------------------|----------------------------------------------------------------------------------------------------------------------| | Common Name: | Anterior Cervical Plate System | | Proposed Regulatory Class: | Class II | | | Spinal Intervertebral Body Fixation Orthosis, | | | 21 CFR 888.3060 | | Device Product Code: | KWQ | | Sponsor: | Stryker Spine | | For Information contact: | Simona Voic | | | Regulatory Affairs Project Manager | | | Stryker Spine | | | 2 Pearl Court | | | Allendale, NJ 07401
Telephone: (201) 760-8145
Fax: (201) 760-8345
Email: Simona.Voic@stryker.com | | Date Summary Prepared: | February 28, 2007 | | Predicate Device | Reflex™ Hybrid ACP System (K062310, K040261)
Synthes Cervical Spine Locking Plate System
(K000536 and K000742) | {1}------------------------------------------------ ## Device Description Intended Use Summary of the Technological Characteristics The Zero Profile ACP System includes anterior cervical plates in one-level and two-level configurations, and in lengths from 12mm to 42mm, depending on the configuration. The subject plates are intended for use with the predicate Reflex HybridTM ACP bone screws. The components of the Zero Profile ACP system are manufactured from Ti6Al4V alloy per ASTM F-136 and will be provided non-sterile. The Zero Profile Anterior Cervical Plating (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: - Degenerative Disc Disease (as defined by neck pain I of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - 트 Trauma (including fractures) - 트 Tumors - I Deformities or curvatures (including kyphosis, lordosis, or scoliosis) - 페 Pseudarthrosis - 트 Failed previous fusion - I Decompression of the spinal cord following total or partial cervical vertebrectomy - 발 Spondylolisthesis - 트 Spinal stenosis WARNING: This device is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The intended use and materials of the subject anterior cervical plates are identical to those of the predicate anterior cervical plates. The new plates feature a lower profile design than the predicate Reflex HybridTM Anterior Cervical Plates, but are used with the predicate Reflex Hybrid™ ACP System screw. {2}------------------------------------------------ Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol. The logo is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Stryker Spine c/o Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401 MAR 2 2 2007 Re: K063430 Trade/Device Name: Zero Profile Anterior Cervical Plate System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 10, 2006 Received: November 13, 2006 Dear Ms. Voic: 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. {4}------------------------------------------------ Page 2 - Ms. Simona Voic 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. 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 yours. Barbara Boehm Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): __K063430_ Device Name: Zero Profile Anterior Cervical Plate System The Zero Profile Anterior Cervical Plating (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: - Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration ■ of the disc confirmed by patient history and radiographic studies) - 트 Trauma (including fractures) - 트 Tumors - Deformities or curvatures (including kyphosis, lordosis, or scoliosis) - 트 Pseudarthrosis - Failed previous fusion - 트 Decompression of the spinal cord following total or partial cervical vertebrectomy - 트 Spondylolisthesis - 트 Spinal stenosis WARNING: This device is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. 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) Verbere Buelld (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page of **510(k) Number** K063430 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K063430](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K063430) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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