(70 days)
Not Found
No
The summary describes a mechanical implant system (screws and plates) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a stabilization system for the cervical spine, used in cases of instability, fractures, spinal stenosis, deformities, tumors, or pseudarthrosis, which are conditions that require therapeutic intervention.
No
Explanation: The device is described as screws and plates for anterior stabilization of the cervical spine, indicating it is an implant used for structural support rather than for diagnosis. Its intended use and device description focus on surgical fixation and stabilization, not on identifying or evaluating medical conditions.
No
The device description explicitly states it consists of "screws and plates" which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The SIMAL Cervical Stabilization Device is described as screws and plates for anterior stabilization of the cervical spine. This is a surgical implant used directly within the body.
- Intended Use: The intended use is "anterior screw fixation of the cervical spine," which is a surgical procedure.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The SIMAL Cervical Stabilization Device is anterior screw fixation of the cervical spine. Fixation is done via ventral or transoral approach. Indications for Use: Spondylolisthesis(instability), fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, or pseudarthrosis
The TSP Cervical Stabilization System is intended for anterior screw fixation.
Indications for Use:
- Spondylolisthesis (instability)
- Fractures
- Spinal Stenosis
- Deformities (Scholiosis, Kyphosis, Lordosis)
- Tumors
- Pseudarthrosis
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The SIMAL Cervical Stabilization System are screws and plates for anterior stabilization of the cervical spine and for anterior C2. C1 stabilization from the transoral approach.
The anterior stabilization plates have large length varieties with four lengths per segment to fit all patient sizes. For the Trans-oral approach "winged" models secure placement of articular grafts.
Both of the types of plates are anchored by titanium screws, which are available in various sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2, C1
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)
Not Found
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.
0
X981008
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MAY 27 1998
510(k) Summary
Top Surgical SIMAL Cervical Stabilization System
1. Submitter's Name, Address and Telephone Number, and Contact Person:
Miss Karenann J. Brozowski
Top Surgical Products c/o TFX Medical Group of Teleflex, Inc. Tall Pines Park Jaffrey, NH 03452
Telephone Number: (603) 532-7706
Contact Person: Karenann J. Brozowski
- Name of the Device, including the trade or proprietary name, if applicable, and the common name, and the classification name, if known.
Trade Name: SIMAL Cervical Stabilization System
Common Name: Spinal Intervertebral Stabilization System
Classification Name: Spinal Intervertebral Body Fixation Orthosis
3. Identification of the legally marketed device that the submitter claims equivalence.
The devices in consideration are substantially equivalent to the devices currently marketed by Aesculap, Caspar Anterior Cervical Fusion Instrumentation System, K953720; Synthes Anterior Cervical Vertebrate Plate System, K945700; and Synthes Cervical Vertebrate Plates, K792352.
A Telefiex Compan,
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4. A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or the promotional material of the device.
The SIMAL Cervical Stabilization System are screws and plates for anterior stabilization of the cervical spine and for anterior C2. C1 stabilization from the transoral approach.
The anterior stabilization plates have large length varieties with four lengths per segment to fit all patient sizes. For the Trans-oral approach "winged" models secure placement of articular grafts.
Both of the types of plates are anchored by titanium screws, which are available in various sizes.
5. Statement of intended use of the device that is the subject of the premarket notification submission.
The intended use of the SIMAL Cervical Stabilization Device is anterior screw fixation of the cervical spine. Fixation is done via ventral or transoral approach. Indications for Use: Spondylolisthesis(instability), fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, or pseudarthrosis
- If the device has the same technological characteristics as the predicate device identified in paragraph (a)(3) of this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to the legally marketed device.
The technological characteristics of the devices are the same. Each of the devices are made of titanium segmented plates and screws with the same characteristic shapes and are anchored by two diameters of titanium screws of various lengths
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are connected by a flowing, ribbon-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 1998
Ms. Karenann J. Brozowski Group Regulatory Affairs Director Top Surgical Products c/o TFX Medical Group of Teleflex, Inc. Tall Pines Park Jaffrey, New Hampshire 03452
Re: K981008 SIMAL Cervical Stabilization System Regulatory Class: II Product Code: KWQ Dated: March 17, 1998 Received: March 18, 1998
Dear Ms. Brozowski:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.
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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f)(1) of the Act.
FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
-
- You may not label or in any way promote this device system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the package insert must include the following statement, "WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";
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- All labeling for this device system, including the package label, must state that there 2. are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and
- Pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral 3. column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note; this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the
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Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page
510(k) Number (if known): K981008
Device Name:__SIMAL Cervical Sterilization System
Indications For Use:
. .
The TSP Cervical Stabilization System is intended for anterior screw fixation
Indications for Use:
-
- Spondylolisthesis (instability)
-
- Fractures
-
- Spinal Stenosis
-
- Deformities (Scholiosis, Kyphosis, Lordosis)
-
- Tumors
-
- Pseudarthrosis
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| 144 | ||
| (Pina. | ||
| esturative Devices | ||
| 3/00B | ||
| ్ | ||
| SIMIN SUITIDE | ||
| Prescription Use_ | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
(Optional Format 1-2-96)