CONKLUSION PEDICLE SCREW SYSTEM

K031455 · Signus Medical, LLC · MNI · Oct 22, 2003 · Orthopedic

Device Facts

• Record ID: K031455
• Device Name: CONKLUSION PEDICLE SCREW SYSTEM
• Applicant: Signus Medical, LLC
• Product Code: MNI · Orthopedic
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Conklusion Pedicle Screw System, including hooks, is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Device Story

ConKlusion Pedicle Screw System is a spinal fixation assembly comprising hooks, screws, rods, and connectors. Used by surgeons via posterior approach to stabilize thoracic, lumbar, and sacral spinal segments. Provides immobilization as an adjunct to fusion. Implants are attached to the spine to treat instabilities or deformities; for severe L5-S1 spondylolisthesis, implants are removed after solid fusion is achieved. System provides mechanical support to the vertebral body to facilitate bone healing.

Clinical Evidence

No clinical data. Bench testing only. Mechanical testing included three static tests (compression bending, tensile bending, torsion) and one dynamic test (compression bending fatigue) conducted in accordance with ASTM F1717. Results were successful, confirming the device met or exceeded all product specifications.

Technological Characteristics

Spinal fixation system consisting of hooks, screws, rods, and connectors. Mechanical testing performed per ASTM F1717. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions: degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudoarthrosis. Also indicated for severe spondylolisthesis (Grade 3-4) at L5-S1 when using autogenous bone graft with implants at L3-S1.

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

• Plus Pivot Link Universal System (K022271)
• Global Spinal Fixation System (K001668)
• Triple-Fix Spinal Fixation System (K992147)

Submission Summary (Full Text)

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# OCT 2 2 2003

# SECTION 2. SUMMARY AND CERTIFICATION

### 510(k) Summary A.

| Submitter: | SIGNUS Medical, LLC. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Thomas Hoghaug, Managing Director<br>SIGNUS Medical LLC<br>6713 Lakeway Drive<br>Chanhassen, MN 55317<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | May 5, 2003 |
| Trade Name: | The ConKlusion Pedicle Screw System |
| Classification, Name<br>and Number: | Class II<br>Pedicle Screw System<br>21 CFR 888.3070 |
| Product Code: | MNI and MNH |
| Predicate Device(s): | The subject device is substantially equivalent to the following<br>devices:<br>● Plus Pivot Link Universal System (K022271), manufactured by<br>SpineVision, Inc.<br>● Global Spinal Fixation System (K001668), manufactured by<br>D.K.M Co., LTD.<br>● Triple-Fix Spinal Fixation System (K992147), manufactured<br>by Advanced Spine Technology, Inc. |
| Device Description: | The ConKlusion Pedicle Screw System is a spinal system that<br>consists of a variety of hooks, screws, rods, connectors, and<br>associated instruments. Fixation is provided by bone (pedicular)<br>screws inserted into the vertebral body of the spine using posterior<br>approach. |
| Intended Use: | The Conklusion Pedicle Screw System, including hook, is intended<br>to provide immobilization and stabilization of spinal segments in<br>skeletally mature patients as an adjunct to fusion in the treatment<br>of the following acute instabilities or deformities of the thoracic,<br>lumbar, and sacral spine: degenerative spondylolisthesis with<br>objective evidence of neurological<br>impairment, fracture. |

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dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Functional and Mechanical testing of the subject device consisted of three static Safety Testing: mechanical tests and one dynamic test to evaluate the spinal implant assemblies. The three static mechanical tests are compression bending, tensile bending, and torsion. The dynamic test is compression bending fatigue. All testing was conducted in accordance with ASTM F1717. The result of the testing was successful. The device performed as designed and met, or exceeded, all product specifications.

SIGNUS Medical LLC considers the ConKlusion Pedicle Screw Conclusion: System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials、 and a indications for use.

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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person's profile.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

SIGNUS Medical, LLC C/o Ms. Tracy L. Gray, R.N., B.S., RAC Senior Consultant Alquest, Inc. 4050 Olson Memorial Hwy., Suite 350 Minneapolis, Minnesota 55422

Re: K031455

> Trade Name: Conklusion® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: September 8, 2003 Received: September 9, 2003

Dear Ms. Gray:

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'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.

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Page 2 - Ms. Tracy L. Gray, R.N., B.S., RAC

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark N. Millers

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

Enclosure

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#### Indications for Use Page .

## Device Name: The Conklusion® Pedicle Screw System

The Conklusion Pedicle Screw System, including hooks, is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to S l ) with removal of the implants after the attainment of a solid fusion.

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A Wilkerson

vision Sion. ision of General, Restorative ad Neurologic

10(k) Number