GII SPINAL FIXATION SYSTEM

K980852 · Karen E. Warden, M.E.B.E. · MNH · May 1, 1998 · Orthopedic

Device Facts

• Record ID: K980852
• Device Name: GII SPINAL FIXATION SYSTEM
• Applicant: Karen E. Warden, M.E.B.E.
• Product Code: MNH · Orthopedic
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GII Spinal Fixation System using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of pedicle screw fixation may be from L3 to the sacrum.

Device Story

GII Spinal Fixation System; orthopedic implant for spinal stabilization. Components: stainless steel or titanium alloy plates, screws, optional spacers. Screws feature cancellous and mechanical threads. Device implanted by surgeons to provide rigid fixation during fusion of L3-sacrum segments; specifically indicated for severe spondylolisthesis (Grades 3-4) at L5-S1. Post-fusion, device is intended for removal. Provides mechanical support to facilitate autogenous bone graft fusion. Risks include component fracture, loss of fixation, non-union, vertebral fracture, neurological/vascular injury.

Clinical Evidence

Bench testing only; static and fatigue mechanical testing performed to support safety and effectiveness.

Technological Characteristics

Materials: stainless steel or titanium alloy. Components: plates (41.1-141.2mm), screws (cancellous/mechanical threads), spacers (3-5mm). Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint requiring spinal fusion with autogenous bone graft. Fixation levels: L3 to sacrum. Contraindicated for use above L5-S1 or in patients with stable spines.

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.

Submission Summary (Full Text)

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216-696-7702

K980852

MAY 1 1998

## 510(k) SUMMARY of Safety and Effectiveness

Sponsor:

Proposed Proprictary Trade Name: Device Description:

Intended Use:

Materials:

Substantial Equivalence:

Performance Characteristics:

Co-Ligne AG

Utoquai 43 8008 Zurich Switzerland

GI Spinal Fixation System

The GII Spinal Fixation System is available in stainless steel and titanium alloy and includes plates, screws and optional spacers. Plates are offered in a variety of lengths (41.1 to 141.2mm) and have longitudinal openings to accommodate the mechanical thread portion of the screw. Screws are have hoth cancellous and mechanical threads, and are available with mechanical thread lengths of 27 or 12mm, cancellous thread lengths ranging from 37 to 52mm in 5mm increments and cancellous thread outer diameters ranging from 5.5 10 8.5mm. Optional spacers are available in 3 or 5mm heights or in a 1.5 to 5mm angled height.

The GII Spinal Fixation System using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the 1.5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of pedicle screw fixation may be from 1.3 to the sacrum.

The GII Spinal Fixation System components are manufactured from cither stainless steel or titanium alloy.

The GII Spinal Fixation System was determined to be substantially equivalent to several commercially available systems.

Static and fatigue mechanical testing were supplied in support of the Gli Spinal Fixation System 510(k) notification.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1998

Ms. Gabriele Treichler Co-Liqne AG Utoquai 43 8008 Zurich Switzerland

K980852 Re : GII Spinal Fixation System Regulatory Class: Unclassified Product Code: MNH Dated: February 18, 1998 March 5, 1998 Received:

Dear Ms. Treichler:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act). found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified 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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.

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This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513 (f.) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

- All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:

## WARNINGS :

- . When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- The screws of this device system are not intended ● for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- . Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
- . Potential risks identified with the use of this device system, which may require additional surgery, include:

device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

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See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

- Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- Any previous warning statements identified as part of 4 . previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531- ----through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.

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Page 4 - Ms. Gabriele Treichler

This letter will allow you to begin marketing your device as fill feece wirr allow for market notification immediately. an 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriance at (50), and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note ons regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5 10(k) Number (if known): K980852 Device Name: GII Spinal Fixation System

Indications For Use:

The GII Spinal Fixation System using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass, The levels of pedicle screw fixation may be from L3 to the sacrum.

## (PLEASE DO NOT WRITE BELOW THIS I.INE - CONTINUE ON ANOTHIER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K960852

| Prescription Use | X |
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(Per 21 CFR 801.109)
OR

| Over-the-Counter Use | _____ |
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