MODIFIED VERTIFLEX SPINAL SCREW SYSTEM

K073143 · Vertiflex, Inc. · MNI · Apr 7, 2008 · Orthopedic

Device Facts

Record IDK073143
Device NameMODIFIED VERTIFLEX SPINAL SCREW SYSTEM
ApplicantVertiflex, Inc.
Product CodeMNI · Orthopedic
Decision DateApr 7, 2008
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3070
Device ClassClass 2
AttributesTherapeutic

Intended Use

When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.

Device Story

Posterior, non-cervical spinal instrumentation system; consists of polyaxial or monoaxial pedicle screws and rigid or semi-rigid connecting rods. Implanted via conventional or minimally-invasive/percutaneous surgical techniques by surgeons. Provides mechanical immobilization and stabilization of spinal segments as an adjunct to fusion. Components are non-sterile; require user sterilization. System accommodates single-level and multi-level procedures. Benefits include structural support for spinal fusion in patients with acute/chronic instabilities.

Clinical Evidence

No clinical testing was conducted to support this submission. Substantial equivalence established via bench testing, including biomechanical studies per ASTM F1717.

Technological Characteristics

Pedicle screw system; polyaxial/monoaxial top-loading screws; rigid/semi-rigid rods. Materials: Titanium alloy (ASTM F136-02) and Titanium (ASTM F67-06). Manual instrumentation for conventional or minimally-invasive implantation. Non-sterile; requires user sterilization.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine instabilities including degenerative spondylolisthesis with neurological impairment, kyphosis, and pseudoarthrosis. Also indicated for patients receiving autogenous graft fusions requiring lumbar or sacral fixation, with subsequent device removal after solid fusion.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K073143 Page 1 of 2 APR - 7 2008 # 5.0 510(k) SUMMARY In accordance with Title 21 Code of Federal Regulations (21 CFR). Part 807, and in particular, §807.92, the following 510(k) summary is provided for the Modified VertiFlex® Spinal Screw System: #### 5.1 Submitted By: VertiFlex®, Incorporated 1351 Calle Avanzado San Clemente, California 92673 Contact: Steve Reitzler, Vice President of Regulatory & Quality Assurance Date Prepared: November 2, 2007 ### 5.2 Device Name Trade or Proprietary Name: Modified VertiFlex® Spinal Screw System Common or Usual Name: Pedicle Screw System Classification Name: Pedicle Screw Spinal System Classification Regulation: 21 CFR, §888.3070 Product Codes: MNH, MNI, NKB # 5.3 Predicate Devices The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate device: VertiFlex® Spinal Screw System - (VertiFlex®, Inc.; K062670) Isobar® TTL System - (Scient'x; K991326, et seq) Dynesvs TM System - (Zimmer Spine: K031511, et seq) N Fix II (N Flex) System -- (N Spine; K061774) CD HORIZON® System - (Medtronic; K063670 & K060615) AccuFlex™ (ProtexTM) System -- (Globus Medical; K0520690 ZODIAC® DYNAMO™ System - Alphatec; K072081) ### Device Description 5.4 The Modified VertiFlex® Spinal Screw System is, like the predicate VertiFlex® Spinal Screw System, a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polvaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136-02, and are available in a range of diameters and lengths to accommodate anatomical requirements. Rods are available in rigid or semi-rigid forms, and are composed of titanium conforming to ASTM F67-06, or titanium alloy (Ti 6Al-4V) conforming to ASTM F136-02. Rods are available in both straight and curved styles, and in a range of lengths to accommodate both single-level and multi-level procedures. The Modified VertiFlex® Spinal Screw System may be implanted by either conventional surgical methods, or using minimallyinvasive/percutaneous techniques. Manual instrumentation for implantation of the Modified VertiFlex® Spinal Screw System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile, and are intended to be sterilized by the user before use. {1}------------------------------------------------ # 073143 Page 2 of 2 # ર્સ્ડ Intended Use When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass. ### 5.6 Comparison to Predicate Devices Testing and comparisons of design characteristics and features have established that the subject Modified VertiFlex® Spinal Screw System is substantially equivalent in design, materials of composition, indications, performance, and other features, to other commercially-available predicate pedicle screw systems having semi-rigid rods. # 5.7 Summary of Non-Clinical Tests Non-clinical tests, including biomechanical studies, and those conducted in accordance with such recognized standards as ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, have demonstrated the substantial equivalence of the subject device to commerciallyavailable predicate devices in terms of performance. ## Summary of Clinical Tests 5.8 No clinical testing was conducted to support this submission. ### 5.9 Conclusions The results of testing and comparisons have established the substantial equivalence of the subject device to the identified predicate devices. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing. Public Health Service APR - 7 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 VertiFlex™, Inc. % Mr. Steve Reitzler VP. Regulatory and Quality Assurance 1351 Calle Avandazo San Clemente, California 92673 Re: K073143 Trade/Device Name: Modified VertiFlex™ Spinal Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NKB, MNI, MNH Dated: March 24, 2008 Received: March 27, 2008 Dear Mr. Reitzler: 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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. The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling: The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established. Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling. {3}------------------------------------------------ Page 2- Mr. Steve Reitzler The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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. Anuley B. Baran Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K073143 Device Name: Modified VertiFlex™ Spinal Screw System Indications for Use: When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass. Prescription Use ﮨﮯ (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R.P. Gdl forman Division of General. Restorative. and Neurological Devices 510(k) Number Ko73143
Innolitics
510(k) Summary
Decision Summary
Classification Order
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