ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)

K030252 · Ortho Tec, LLC · KWP · Feb 21, 2003 · Orthopedic

Device Facts

• Record ID: K030252
• Device Name: ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
• Applicant: Ortho Tec, LLC
• Product Code: KWP · Orthopedic
• Decision Date: Feb 21, 2003
• Decision: SESE
• Submission Type: Special
• 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 in spinal fusion surgery. Components include lumbar, thoracic, and pedicular hooks; sacral and pedicle screws; set screws; locking nuts; rods; and connectors. Surgeons assemble these components intraoperatively to match patient anatomy and physiological requirements. The system provides immobilization and stabilization of spinal segments. It is intended for use in the thoracic, lumbar, and sacral spine to treat various instabilities and deformities. The device is implanted by a surgeon in an operating room setting. It provides mechanical support to the spine to facilitate fusion and improve patient outcomes in cases of degenerative disease, trauma, or deformity.

Clinical Evidence

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

Technological Characteristics

Construct components include hooks, screws, rods, and connectors. Extended OmniAxial Connectors (CO05 & CO07) are manufactured from titanium alloy (ASTM F136-98). System is a mechanical spinal fixation orthosis.

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization/immobilization for degenerative disc disease, spondylolisthesis (including severe L5-S1 grades 3-4), fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, pseudarthrosis, or failed previous fusion. Used as adjunct to fusion with autogenous bone graft in 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.

Predicate Devices

• OmniAxial Connector (CO04)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K030252
Page 1 of 1

FEB 2 1 2003

Manager

| 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 |

Proprietary ORIA Spinal Clip System Trade Name:

Device The ORIA Spinal Clip System includes components that fit together to form a Description: construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

Intended Use: When used as a nonpedicle, noncervical posterior system, the ORLA 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 (1) degenerative spondylolisthesis with objective evidence of sacral spine: neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis. (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & Materials: CO07) are manufactured from titanium alloy (ASTM F136-98).

Substantial Equivalence: Documentation was provided which demonstrated the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to be substantially equivalent to the previously cleared OmniAxial Connector (CO04). The substantial equivalence is based upon equivalence in indications/intended use. manufacturing methods, interconnection (attachment) mechanism, basic design and materials.

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Public Health Service

Image /page/1/Picture/2 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 an eagle with three overlapping profiles, representing health and human services.

FEB 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eurosurgical, S.A. c/o Ms. Karen E. Warden, MEBE REO Spine Line 7000 Hampton Center, Suite G1 Morgantown, WV 26505

Re: K030252

Trade/Device Name: ORIA Spinal Clip System Extended Omniaxial Connector Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis; Spondylolisthesis spinal fixation device system; Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: January 21, 2003 Received: January 24, 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. Iisting 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

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Page 2 – Ms. Karen E. Warden

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. 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 yours,

Miriam C. Provost

for 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): |< 030252

#### 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 (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).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Miriam C. Provost

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510(k) Number: K030252