MODIFICATION TO ORIA TOP CLIP SYSTEM

K040346 · Ortho Tec, LLC · MNI · Mar 12, 2004 · Orthopedic

Device Facts

• Record ID: K040346
• Device Name: MODIFICATION TO ORIA TOP CLIP SYSTEM
• Applicant: Ortho Tec, LLC
• Product Code: MNI · Orthopedic
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ORIA Top Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 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 solid fusion mass. When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Top Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

Device Story

ORIA Top Clip System is a pedicle screw spinal system; components include pedicle screws, set screws, top locking clips, and rods. Used by surgeons in clinical settings to build custom implant constructs for spinal stabilization and immobilization. Device provides mechanical support to spinal segments as an adjunct to fusion; facilitates stabilization in patients with acute/chronic instabilities or deformities. Surgeon selects and assembles components to match patient anatomy; device remains in situ to support fusion and may be removed after solid fusion mass development.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67 GR2) and titanium alloy (ASTM F136). Components: Pedicle screws, set screws, top locking clips, rods. Mechanical fixation system for spinal stabilization.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions: severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis. Used in thoracic, lumbar, and sacral spine.

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)

{0}------------------------------------------------

## · Attachment VII: 510(k) Summary

K040346
page 1 of 1

| Sponsor: | Eurosurgical, SA<br>B.P.23-18, rue Robespierre<br>Beaurains, France 62217<br>Phone: [phone], Fax: [phone] |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact<br>Person: | Emmanuel Margerit, Regulatory Affairs and Quality Manager |
| Proprietary Trade<br>Name: | ORIA Top Clip System |
| Device<br>Description: | The ORIA Top Clip System includes components made from commercially pure<br>titanium and titanium alloy described by ASTM Standards F67 GR2 and ASTM<br>F136, respectively. These components are available in various designs and sizes that<br>allow the surgeon to build an implant construct suited to a patient's anatomical and<br>physiological requirements. The components include: pedicle screws, set screws, top<br>locking clips and rods. |
| Intended Use: | ORIA Top Clip System is indicated for skeletally mature patients: (1) having severe<br>spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions<br>using autogenous bone graft only; (3) who are having the device fixed or attached to<br>the lumbar and sacral spine (L3 and below); and (4) who are having the device<br>removed after the development of solid fusion mass. <p> When used as a pedicle screw system in the non-cervical spine of skeletally mature<br/>patients, the ORIA Top Clip System is indicated for immobilization and stabilization<br/>of spinal segments as an adjunct to fusion in the treatment of the following acute and<br/>chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1)<br/>degenerative spondylolisthesis with objective evidence of neurological impairment,<br/>(2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7)<br/>failed previous fusion (pseudarthrosis). </p> |
| Materials: | The ORIA Top Clip System components are manufactured from implant grade<br>materials of pure commercial titanium and titanium alloy described by ASTM<br>Standards F67 GR2 and ASTM F136, respectively. |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the ORIA Top Clip System to be<br>substantially equivalent to a previously cleared system. The substantial equivalence<br>is based upon equivalence in fundamental scientific technology (manufacturing,<br>attachment configuration, basic design and materials) and indications/intended use. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three lines representing its wings.

MAR 1 2 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eurosurgical, SA C/o Ms. Karen E. Warden, MEBE REO Spine Line 7000 Hampton Center, Suite G1 Morgantown, West Virginia 26505

Re: K040346

Trade/Device Name: ORIA Top Clip System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: February 11, 2004 Received: February 12, 2004

Dear Ms. Warden:

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 complics 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.

{2}------------------------------------------------

Page 2 - o Ms. Karen E. Warden, MEBE

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 vours.

Sincerey, yours,

Mark A. Mellema

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

{3}------------------------------------------------

## Attachment II: Indications for Use Statement

510(k) Number (if known): Kod 03d

Device Name: ORIA Top Clip System

Indications for Use:

ORIA Top Clip System is indicated for skelctally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 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 (1,3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the OR1A Top Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

Mark N. Melkerso

K040346

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

ાર

Over-the-Counter Use_