ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ

K023994 · Ortho Tec, LLC · MNH · Feb 5, 2003 · Orthopedic

Device Facts

• Record ID: K023994
• Device Name: ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
• Applicant: Ortho Tec, LLC
• Product Code: MNH · Orthopedic
• Decision Date: Feb 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. ORIA Spinal 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 Spinal 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 Spinal Clip System is a posterior spinal fixation construct used in spinal fusion surgery. Components include lumbar, thoracic, and pedicular hooks; sacral and pedicle screws; set screws; locking nuts; rods; and connectors. Surgeon assembles construct intraoperatively to match patient anatomy and physiological requirements. System provides immobilization and stabilization of spinal segments to facilitate fusion. Used in clinical settings by surgeons. Benefits include structural support for spinal instabilities and deformities.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Components manufactured from pure commercial titanium (ASTM F-67-95 GR2), titanium alloy (ASTM F-136-98), or 316LVM stainless steel (ASTM F-138-97, Grade 2). System includes hooks, screws, rods, and connectors for posterior spinal fixation.

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization/immobilization for degenerative disc disease, spondylolisthesis (including severe L5-S1), fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, dislocation, or failed previous fusion. Used as adjunct to fusion with autogenous bone graft 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.

Predicate Devices

• Type "V" screws

Submission Summary (Full Text)

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## 510(k) SUMMARY

# FEB 0 5 2003

| 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 Spinal Clip System |
| Device<br>Description: | The ORIA Spinal Clip System includes components that fit together to form a<br>construct for use during spinal fusion surgery. The system contains components of<br>various designs and sizes that allow the surgeon to build an implant system for each<br>of four defined indications and to fit the patient's anatomical and physiological<br>requirements. The components include: Lumbar, thoracic, and pedicular hooks;<br>Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths;<br>Connectors with set screws (sacral, transverse, lateral); Connecting elements;<br>Instruments and Sterilizer trays. |
| Intended Use: | When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip<br>System is indicated for: (1) degenerative disc disease (defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by history and<br>radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5)<br>deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7)<br>tumor resection, and/or (8) failed previous fusion. |
| | ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having<br>severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving<br>fusions using autogenous bone graft only; (3) who are having the device fixed or<br>attached to the lumbar and sacral spine (L3 and below); and (4) who are having the<br>device removed after the development of solid fusion mass. |
| | When used as a pedicle screw system in the non-cervical spine of skeletally mature<br>patients, the ORIA Spinal Clip System is indicated for immobilization and<br>stabilization of spinal segments as an adjunct to fusion in the treatment of the<br>following acute and chronic instabilities or deformities of the thoracic, lumbar, and<br>sacral spine: (1) degenerative spondylolisthesis with objective evidence of<br>neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6)<br>spinal tumor, and (7) failed previous fusion (pseudarthrosis). |
| Materials: | The ORIA Spinal Clip System components are manufactured from implant grade<br>materials of pure commercial titanium and titanium alloy described by ASTM<br>Standards F-67-95 GR2 and ASTM F-136-98, respectively, or of implant grade<br>stainless steel described by ASTM Standard F-138-97, Grade 2 (316LVM Stainless<br>Steel). |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the ORIA Spinal Clip System<br>Polyaxial Screws to be substantially equivalent to the previously cleared Type "V"<br>screws. The substantial equivalence is based upon equivalence in fundamental<br>scientific technology and indications/intended use. |

Confidential: VORIA SPINAL CLIP SYSTEM Polyaxial Screw Modification

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings.

Public Health Service

FEB 0 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K023994 Re:

Trade Name: ORIA Spinal Clip System Regulation Number: 888.3070 and 888.3050 Regulation Name: Pedicle Screw Spinal System and Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI and KWP Dated: January 7, 2003 Received: January 8, 2003

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 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. 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 yours,

Mike N Milken

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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### Indications for Use Statement

### 510(k) Number (if known): K023994

#### Device Name: ORIA Spinal Clip System

Indications for Use:

When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at LS-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 Spinal 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 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).

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

| | for Mark N |
|--|------------|
|--|------------|

concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off) | | |
|-----------------------------------------------------------|---------|----------------------|
| Division of General, Restorative and Neurological Devices | | |
| 510(k) Number | K023994 | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use |

Confidential: ORIA SPINAL CLIP SYSTEM Polyaxial Screw Modification

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