MODIFICATION ORIA SPINAL SYSTEM

K023884 · Ortho Tec, LLC · KWP · Aug 20, 2003 · Orthopedic

Device Facts

• Record ID: K023884
• Device Name: MODIFICATION ORIA SPINAL SYSTEM
• Applicant: Ortho Tec, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• 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 during 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 fit patient anatomy and physiological requirements. Device provides immobilization and stabilization of spinal segments to facilitate fusion. Used in OR by surgeons. Benefits include structural support for spinal instabilities and deformities.

Clinical Evidence

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

Technological Characteristics

Construct components include hooks, screws, rods, and connectors. Materials: titanium, titanium alloy, stainless steel. Mechanical fixation system for spinal stabilization.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for degenerative disc disease, spondylolisthesis (including severe L5-S1 grades 3-4), fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, pseudarthrosis, and failed previous fusion in the thoracic, lumbar, and sacral spine.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Submission Summary (Full Text)

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# AUG 2 0 2003

K023884
Page 1 of 1

# 510(k) SUMMARY

| Sponsor: | Eurosurgical, SA<br>B.P.23-18 rue Robespierre<br>Beaurains, France 62217<br>Phone: [phone], Fax: [phone] |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Emmanuel Margerit, Regulatory Affairs and Quality Manager |
| Proprietary<br>Trade 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<br>of various designs and sizes that allow the surgeon to build an implant system<br>for each of four defined indications and to fit the patient's anatomical and<br>physiological requirements. The components include: Lumbar, thoracic, and<br>pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods<br>in various lengths; Connectors with set screws (sacral, transverse, lateral);<br>Connecting elements; 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.<br><br>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<br>or attached to the lumbar and sacral spine (L3 and below); and (4) who are<br>having the device removed after the development of solid fusion mass.<br><br>When used as a pedicle screw system in the non-cervical spine of skeletally<br>mature patients, the ORIA Spinal Clip System is indicated for immobilization<br>and stabilization of spinal segments as an adjunct to fusion in the treatment of<br>the following acute and chronic instabilities or deformities of the thoracic,<br>lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective<br>evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis,<br>(5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis). |
| Materials: | The ORIA Spinal Clip System components are manufactured from titanium,<br>titanium alloy and stainless steel. |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the ORIA Spinal Clip<br>System components to be substantially equivalent to previously cleared devices.<br>The substantial equivalence is based upon equivalence in indications for use,<br>anatomic sites, design, material of manufacture, and function. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling an abstract representation of a bird or a symbol of health and well-being. The logo is black and white.

AUG 2 0 2003

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eurosurgical S.A. c/o Mr. David Schlerf Buckman Company, Inc. 200 Gregogry Lane, Suite C-100 Pleasant Hill, CA 94523

Re: K023884

Trade/Device Name: ORIA Spinal Clip System Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI Dated: May 16, 2003 Received: May 23, 2003

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'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 - Mr. David Schlerf

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" (21 CFR 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.

Sincerely yours,

Mark N. Milliman

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 Statement

510(k) Number (if known): K023884

### 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) 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 (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 ORIA Spinal Clip System is indicated for immobilization 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).

f
Manh N Milhun
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number **__** K023884

(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) | |

OR

Over-the-Counter Use

Karen E. Warden, ORIA Spinal Clip System DRAFT

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