VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM

K050588 · Innovative Spinal Design, LLC · KWQ · Apr 21, 2005 · Orthopedic

Device Facts

Record IDK050588
Device NameVERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
ApplicantInnovative Spinal Design, LLC
Product CodeKWQ · Orthopedic
Decision DateApr 21, 2005
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3060
Device ClassClass 2
AttributesTherapeutic

Intended Use

This system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or dislocation), 3) tumors, 4) spinal stenosis, 5) spondylolisthesis, 6)deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions. WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

Device Story

Verteview Anterior Cervical Plate System is a spinal fixation orthosis used for temporary stabilization during cervical fusion. System components include titanium alloy plates, variable angle bone screws, and locking tabs. Implants are inserted via anterior approach into vertebral bodies. Screws are color-anodized to differentiate type and diameter. Device is used by surgeons in clinical settings to provide structural support during bone healing. Benefits include stabilization of the cervical spine in patients with degenerative, traumatic, or deformity-related conditions.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ASTM F1717-04, 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model,' to demonstrate mechanical equivalence to the predicate device.

Technological Characteristics

Titanium alloy construction with titanium anodization per AMS 2488 Type II. System includes plates, variable angle bone screws, and locking tabs. Mechanical testing per ASTM F1717-04. Components supplied clean, non-sterile.

Indications for Use

Indicated for temporary stabilization of anterior spine during cervical fusion in patients with degenerative disc disease, trauma (fractures/dislocation), tumors, spinal stenosis, spondylolisthesis, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, or failed previous fusions. Contraindicated for posterior element (pedicle) attachment.

Regulatory Classification

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ APR 2005 OSDSS88 // 510(k) Premarket Notification Submission -Verteview Anterior Cervical Plate System # 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS ### DEVICE INFORMATION | Date Prepared: | March 7, 2005 | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Submitter Name/Address: | Innovative Spinal Design, LLC<br>1115 Jupiter Park Drive #4<br>Jupiter, FL 33458 | | Contact: | Leigh Cowden | | Telephone Number: | 561.741.1108 | | Fax Number: | 561.741.1870 | | Email: | leigh@innovativespinaldesign.com | | Device Trade Name: | Verteview Anterior Cervical Plate System | | Common Name:<br>Regulatory Number:<br>Classification:<br>Product Code: | Spinal Intervertebral Body Fixation Orthosis, Anterior Cervical Plate System<br>888.3060<br>Class II<br>KWQ | # SUMMARY INTENDED USES/INDICATIONS This system is indicated for use in the temporary stabilization of the anterior spine during the I his system is final fusions in the tomatients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or dislocation), 3) tumors, 4) spinal stenosis, 5) spondylolisthesis, 6)deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions. WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT TO THE POSTERIOR WANNINGS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE. ## SUMMARY DEVICE DESCRIPTION SUMMAN i DEVICE System is a fixation device consisting of a variety of a variety of sizes of The veltew / menor our fiate your variable angle bone screws, and associated instruments. cervical places, locking tabs, fixod and Terred into the vertebral body of the cervical spine using the Frixation is provided by bone serews moorted into the released and and the many of the in antenor approad. The screws have various diameters. All components are supplied clean not sterile. The Verteview Anterior Cervical Plate System implant components are made from titanium alloy The Verteview Antenor Ocenour nato eyeten interested with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter. #### EQUIVALENT DEVICE EQUIVALENT DEVIOE Testing in accordance with ASTM F1717-04 "Standard Test Methods for Spinal Implant Contructs in a Testing in accordance with : Verteview Anterior Cervical Plate System demonstrates that the device venebreconty Moder of the Vertenew Anterior CSLP System (K030866, concurrence date Is sustantially equivalent to the Oynthos Opine Anterior Cervical Plate System (K010003, concurrence date January 31, 2001.) {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird. Public Health Service APR 2 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Leigh Cowden CEO Innovative Spinal Design, LLC 1555 Jupiter Park Drive, Suite 4 Jupiter, Florida 33458 Re: K050588 Trade/Device Name: Verteview Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 7, 2005 Received: March 9, 2005 Dear Ms. Cowden: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becternined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to tegans actment date of the Medical Device Amendments, or to commerce provide that have been reclassified in accordance with the provisions of the Federal Food. Drug. de vices mat have been receire approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that ac novice, subject to the general controls provisions of the Act. The I ou may, mercere, mailer are a Act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device is classified (500 abor of the Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outseenents concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri 3 localited on the vice complies with other requirements of the Act that IDA has made a decormination an administered by other Federal agencies. You must or any receral statutes and regulations and adming, but not limited to: registration and listing (21 comply with an the Act 3 requirements, morading, worder of the requirements as se CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 -- Ms. Leigh Cowden This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your arrantial equivalence of your device to a legally premarket nothication: "The PDA midning of backannal or p 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 If you desire specific advice for your do not our called on our and the regulation entitled, and contact the Office of Comphance at (210) 21 0 0 0 0 0 0 0 0 0 0 0 may obtain other IMISoraniumly by reference to premaibilities under the Act from the Division of Small general information on your responsionnes Assistance at its toll-free number (800) 638-2041 or and Manufacturers, International and Consultation of the consideration of the many in the saltml. Sincerely yours, Stypt Rhodes Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number: K050588 Device Name: Verteview Anterior Cervical Plate System Indications for Use: This system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or the use committentures, 4) spinal stenosis, 5) spondylolisthesis, 6)deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions. warning: This device is not intended for Screw atTACHMENT TO THE POSTERIOR WANNING: THIS DEVISE IS THE CERVICAL, THORACIC, OR LUMBAR SPINE. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Stupt Cluorlu tern). Restorative. Division of Ge and Neurologial Devices KOSO588 510(k) Number_
Innolitics
510(k) Summary
Decision Summary
Classification Order
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