GII SPINAL FIXATION SYSTEM

K051089 · Co-Ligne AG · MNH · Oct 26, 2005 · Orthopedic

Device Facts

• Record ID: K051089
• Device Name: GII SPINAL FIXATION SYSTEM
• Applicant: Co-Ligne AG
• Product Code: MNH · Orthopedic
• Decision Date: Oct 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass. The GII system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

Device Story

GII OstaPek® Plate is a spinal fixation component designed for use within the GII Spinal Fixation System. The plates are manufactured from a polymer matrix of Polyetherketoneketone (PEKEKK) resin and long carbon fiber filaments. They are provided precurved to match the lumbar lordotic curve and are available in various sizes based on slot/hole count. The device is intended for use by experienced spinal surgeons in the OR to provide immobilization and stabilization of the non-cervical spine as an adjunct to fusion. It integrates with existing GII system pedicle screws, nuts, washers, and cross-links. Because the material is non-metallic, it eliminates concerns regarding galvanic or corrosive interactions with existing metallic implants. The output is a stabilized spinal construct that facilitates bone fusion, potentially reducing pain and correcting spinal deformities.

Clinical Evidence

Bench testing only. Fatigue, static, and biocompatibility testing were performed according to accepted engineering and scientific principles. Results demonstrate performance equivalent or superior to the previously cleared GII Spinal Fixation System plates.

Technological Characteristics

Material: Polyetherketoneketone (PEKEKK) resin with long carbon fiber filaments. Form factor: Precurved plates with varying slot/hole configurations. Connectivity: None (mechanical implant). Sterilization: Not specified. Standards: Utilizes voluntary standards including ASTM, ISO materials standards, and ISO 13485 series quality regulations.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical posterior spinal fixation for degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion, or degenerative disc disease. Specific pedicle screw use indicated for L5-S1 severe spondylolisthesis (Grades 3-4) using autogenous bone graft, with fixation at L3 and below.

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

• GII Spinal Fixation System (K980852 - K032604)

Submission Summary (Full Text)

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| <b>510(k) Summary Information</b><br>Premarket Notification, Section 510(k) | COLIGNE AG.<br>OCTOBER 21, 2005 |
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Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

Device Name: 1.

> Trade Name: GII OstaPek® Plate

Common Pedicle screw spinal system Name(s):

Classification Pedicle screw spinal system, spine plate Name(s):

### Establishment Name & Registration Number: 2.

| Name: | coLigne AG |
|---------|------------|
| Number: | 9614472 |

#### 3. Classification(s):

# Sec. & 888.3070 Pedicle screw spinal system

(a) Identification. Pedicle screw spinal systems are multiple component devices, made from a variety of matcrials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, 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 anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

(b) Classification. (1) Class II (special controls), when intended to provide immobilization 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; spinal turnor; 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 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 LS-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal turnor, 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."

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(2) Class III (premarket approval), when intended to provide immobilization and stabilization of sainal (2) Class in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc signifits in the moracie, and sither severe spondylolisthesis (grades 3 and 4) at LS-SI or degenerative spondylolisthesis with objective evidence of neurologic impairment.

| Device Class: | Class II or Class III for the requested indications |
|-----------------------|-----------------------------------------------------|
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
| Product Code(s): | MNI, MNH, KWP |

### Equivalent Predicate Device: 4.

COLIGNE AG. believes that the GII OstaPek® Plate is substantially equivalent to the plates currently offered in the GII Spinal Fixation System identified below:

# K980852 - K032604, GII Spinal Fixation System

Equivalence can be seen in the design, material composition, surgical technique and intended use.

#### Device Description: 5.

# General description of the new plate.

General description of the new patel.
The new plates are offered in a series of sizes designated by the number of slots or holes within the plates. The I ho w plates are single slot. The new plates are provided precurved to more closely match the natural lordotic curve of the lumbar spine. Two different curves are offered in each size.

The devices are produced of a polyner matrix of Polyetherketonekctone (PEKEKK) Resins and long fiber carbon filaments.

The new plates are intended to be used with the existing pedicle screws, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. Because the new material is not a metallic material, precautions against mixing dissimilar metals or of a galvanic/corrosive interaction with the existing implants is eliminated.

The previously cleared indications for use are unchanged.

Testing Summary. Fatigue, static and biocompatibility testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the new plates perform in a manner equivalent or superior to the previously cleared GII Spinal Fixation System plates.

Indications for Use. The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spinc in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (LS-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The GII system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

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### Applicant Name & Address: 6.

coLigne AG Utoquai 43 Zurich, Switzerland 8008 41-433-438000 41-433-438009 - fax Registration Number: 9614472

### 7. Company Contact:

Robert Lange coLigne AG Utoquai 43 Zurich, Switzerland 8008 41-433-438000 41-433-438009 – fax

### Submission Correspondent: 8.

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

#### 0. Performance Standards:

United States Food and Drug Administration mandated performance s tandards for this device do not exist. Various voluntary performance are utilized. Voluntary standards utilized include ASTM, Standard Various volunary performance as certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 13485 series quality regulations.

coLigne AG. also meets appropriate general controls authorized under Sections 501, 502, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2005

CoLigne AG c/o David W. Schlerf Buckman Company, Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389

Re: K051089

Trade/Device Name: GII Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, KWP, MNH Dated: September 22, 2005 Received: September 26, 2005

Dear Mr. Schlerf:

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 is 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 numsi 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,

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Page 2- David W. Schlerf

This letter will allow you to begin marketing your device as described in your Section 5 10(k) i his letter will anow you to ocgin nameoning your article of your device to a legally premarket nothleadon: The FDA mining of basistants
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 device on our an and one as note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the No contact the Office of Complance at (21) = 1) = 1 = 1 807.97). You may obtain "Misoranding by reference to premanterialities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number : K051089

GII Spinal Fixation System Device Name(s):

# Indications For Use:

The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ In the foll correcar posteries of the following: (1) degenerative Spondylolisthesis with objective evidence of neurologic impairment, (2) spondylonomon (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the GII@ Spinal In addition, which about for skeletally mature patients: (1) having severe System 16 Thereates 3 and 4) of the fifth lumbar/first sacral (L5-S 1) spondylonstiles. (eseiving fusions using autogenous bone graft only; (3) who John, (2) who are receiving or attached to the lumbar and sacral spine (L3 and are having the device intos in g the device removed after the development of a solid fusion mass.

The GII system is also a hook and sacral/iliac screw fixation system of the The On System 15 also a 1100r (1) degenerative disc disease (defined as back non of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degencrative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use __

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

(Per 21 CFR 801.109)

(Optional format 1-2-96)

510(k) Number 4051 084