(272 days)
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).
The ORIA Spinal Clip System includes components that fit together to form a 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.
The provided text is a 510(k) summary for the ORIA Spinal Clip System. It describes the device, its intended use, and states that it is substantially equivalent to previously cleared devices. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-enabled devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, primarily through comparison of indications for use, anatomic sites, design, materials, and function, rather than through performance metrics for an AI algorithm.
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AUG 2 0 2003
K023884
Page 1 of 1
510(k) SUMMARY
| Sponsor: | Eurosurgical, SAB.P.23-18 rue RobespierreBeaurains, France 62217Phone: 33-3-2121 5960, Fax: 33-3-2121 5970 |
|---|---|
| ContactPerson: | Emmanuel Margerit, Regulatory Affairs and Quality Manager |
| ProprietaryTrade Name: | ORIA Spinal Clip System |
| DeviceDescription: | The ORIA Spinal Clip System includes components that fit together to form aconstruct for use during spinal fusion surgery. The system contains componentsof various designs and sizes that allow the surgeon to build an implant systemfor each of four defined indications and to fit the patient's anatomical andphysiological requirements. The components include: Lumbar, thoracic, andpedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rodsin 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 ORIA Spinal ClipSystem is indicated for: (1) degenerative disc disease (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic 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) havingsevere spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receivingfusions using autogenous bone graft only; (3) who are having the device fixedor attached to the lumbar and sacral spine (L3 and below); and (4) who arehaving the device removed after the development of solid fusion mass.When used as a pedicle screw system in the non-cervical spine of skeletallymature patients, the ORIA Spinal Clip System is indicated for immobilizationand stabilization of spinal segments as an adjunct to fusion in the treatment ofthe following acute and chronic instabilities or deformities of the thoracic,lumbar, and sacral spine: (1) degenerative spondylolisthesis with objectiveevidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis,(5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis). |
| Materials: | The ORIA Spinal Clip System components are manufactured from titanium,titanium alloy and stainless steel. |
| SubstantialEquivalence: | Documentation was provided which demonstrated the ORIA Spinal ClipSystem components to be substantially equivalent to previously cleared devices.The substantial equivalence is based upon equivalence in indications for use,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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
PAGE 3
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
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.(b)
Classification. Class II.