Radix Cervical Plate is intended for anterior screw fixation of the cervical spine.
Device Story
Radix Cervical Plate is a spinal intervertebral body fixation orthosis used in anterior cervical spine surgery. Device consists of a pre-contoured metal plate (38mm-60mm lengths) secured to anterior vertebral bodies via self-tapping unicortical bone screws (3.9mm diameter, 10mm-18mm lengths). Plate features six holes allowing variable screw angulation. Surgeon implants device during open procedure to provide stabilization. Pre-contouring and self-tapping screws facilitate anatomical adaptation and reduce operative time. Device provides structural support to facilitate fusion in patients with degenerative, traumatic, or neoplastic spinal conditions.
Clinical Evidence
Bench testing only. Mechanical testing performed according to ASTM 1717 standards; results comparable to predicate cervical plates.
Technological Characteristics
Spinal intervertebral body fixation orthosis. One or two-level plate with six holes for variable-angle screw fixation. Materials: metal (unspecified). Dimensions: 38mm-60mm plate lengths; 3.9mm diameter screws (10mm-18mm lengths). Features: pre-contoured geometry, self-tapping screw threads. Mechanical testing per ASTM 1717.
Indications for Use
Indicated for patients requiring anterior cervical spine fixation for degenerative disc disease (discogenic pain confirmed by history/radiography), spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion. Not for posterior element (pedicle) fixation.
Regulatory Classification
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
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510(k) Summarv
Date December 19, 2003
Submitter Pisharodi Surgicals, Inc. 942 Wildrose Lane Brownsville, TX 78520
Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681
512-388-0199
Common name Anterior vertebral body fixation system
### Classification name
Spinal Intervertebral Body Fixation Orthosis per 21 CFR section 888.3060.
### Equivalent Device
The Radix Cervical Plate is equivalent in design, material and indications as the Synthes Anterior CLSP System (K030866) and EBI VueLock Cervical Plate (K010003).
#### Device Description
The Radix Cervical Plate is a one or two level plate that is secured to the anterior cervical vertebral bodies with unicortical bone screws. The plate is available in twelve lengths ranging from 38mm to 60mm in lengthe. It has six holes to receive the bone screws. The screw holes allow variable angulation of the screws.
Ease of intra-operative handling is enhanced by pre-contouring the plates in two directions to facilitate adaptation to the patient's anatomy and self-tapping uni-cortical screws, which shorten operating time. The acrews are 03.9mm and are available in five lengths, 10mm to 18mm. The self-tapping thread of the screws eliminates are ed or preliminary tapping.
# Intended Use
Radix Cervical Plate is intended for anterior screw fixation of the cervical spine.
Indications for use include:
- degenerative disc disease (ddd) defined as back pain of discogenic o rigin with degeneration of the disc . confirmed by history and radiographic studies.
- . spondylolisthesis
- trauma (i.e., fracture or dislocation) .
- . spinal stenosis
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- . tumor
- . pseudoarthrosis
- . failed previous fusion
Warning:'' This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."
# Summary of Technological Characteristics Compared to Predicate Device
The Radix Cervical Plate is similar in material, plate lengths, ability to angulate and lock the bone screws, precontoured plates and indications.
## Summary Nonclinical Tests
Testing was performed according to ASTM 1717 with results comparable to other cervical plates.
JUL 0 1 2004
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 1 2004
Pisharodi Surgicals, Inc. C/o J.D. Webb The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K033951
Trade/Device Name: Radix Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 19, 2004 Received: April 22, 2004
Dear Mr. Webb:
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 - J.D. Webb
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) 594-4692. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html.
Sincerely vours.
Miriam C. Provost
Calia 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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510(k) number (if known): KO3399
Device Name: Radix Cervical Plate
Indications for Use:
# Radix Cervical Plate Indications for Use
Radix Cervical Plate is intended for anterior screw fixation of the cervical spine.
Indications for use include:
- · degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- · spondylolisthesis
- · trauma (i.e., fracture or dislocation)
- · spinal stenosis
- · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- tumor
- · pseudoarthrosis
- · failed previous fusion
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use V (per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional format 1-2-96)
)
Muriam C. Provost
(Division Sign-off) Division of General, Neurological and Restorative Devices
510(k) Number K633951
