(70 days)
Not Found
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is described as providing "stabilization during the development of a solid spinal fusion," which is a therapeutic intervention for various spinal conditions listed in the indications for use.
No
The SIMPLEX Cervical Fixation System is described as a device used for anterior screw fixation of the cervical spine to provide stabilization during spinal fusion, not to diagnose medical conditions.
No
The device description clearly states the system consists of "plates and is used to build a spinal construct," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The SIMPLEX Cervical Fixation System is a system of plates and screws designed for surgical implantation to stabilize the cervical spine. It is a physical implant used in the body, not a device used to test samples from the body.
- Intended Use: The intended use is for anterior screw fixation of the cervical spine to treat various spinal conditions. This is a surgical procedure, not a diagnostic test.
The information provided clearly describes a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SIMPLEX Cervical Fixation System 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
Warning: "This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The SIMPLEX Cervical Fixation System consists of plates and is used to build a spinal construct. The purpose of the SIMPLEX Cervical Fixation System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes.
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 screws are available in five lengths. The self-tapping thread of the screws eliminates the need for preliminary tapping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed according to ASTM 1717 with results comparable to other cervical plates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.
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Page 1 of 1
510(k) Summary for the SIMPLEX Cervical Fixation System
APR 16 2007
This safety and effectiveness summary for the SIMPLEX Cervical Fixation System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
Date Prepared: January 31, 2007
| 1. | Submitter: | Contact Person: |
|---|---|---|
| Pisharodi Surgicals, Inc. | J.D. Webb | |
| 942 Wildrose Lane | The OrthoMedix Group, Inc. | |
| Brownsville, TX 78520 | 1001 Oakwood Blvd | |
| Telephone: 956-541-6725 | Round Rock, TX 78681 | |
| Telephone: 512-388-0199 |
| 2. Trade name: | SIMPLEX Cervical Fixation System |
|---|---|
| Common Name: | Anterior vertebral body fixation system |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis per 21 CFR section 888.3060 |
- ന് Predicate or legally marketed devices which are substantially equivalent: Radix Cervical Plate - K033951
4. Description of the device:
The SIMPLEX Cervical Fixation System consists of plates and is used to build a spinal construct. The purpose of the SIMPLEX Cervical Fixation System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes.
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 screws are available in five lengths. The self-tapping thread of the screws eliminates the need for preliminary tapping.
ഗ് Intended Use:
The SIMPLEX Cervical Fixation System 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 fordosis)
- . 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."
- Comparison of the technological characteristics of the device to predicate and legally marketed devices: ల్.
The SIMPLEX Cervical Fixation System is similar in material, plate lengths, ability to angulate and lock the bone screws, pre-contoured plates and indications.
7. Summary of Nonclincal Tests
Testing was performed according to ASTM 1717 with results comparable to other cervical plates.
1
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 stylized depiction of an eagle or bird with three wing-like shapes, positioned to the right of a circular border. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pisharodi Surgicals, Inc. % Mr. J.D. Webb Authorized Contact Person 1001 Oakwood Blvd. Round Rock, Texas 78681
APR 16 2007
K070335 Re:
Trade/Device Name: SIMPLEX Cervical Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 16, 2007 Received: March 19, 2007
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.
2
Page 2 - Mr. J.D. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) r market 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 in you attime of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Karbar Bonchra
Mark N. Melkerson Director Division of Gencral, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K070335
Device Name: ___ SIMPLEX Cervical Fixation System
Indications for Use:
The SIMPLEX Cervical Fixation System 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
Warning: "This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saubare Buchun
Division of General, Restorative, and Neurological Devices
510(k) Number Ko 70335