(228 days)
Not Found
No
The 510(k) summary describes a physical spinal implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a spinal implant used to replace resected vertebral bodies, which directly treats a medical condition (tumor or trauma/fracture) and restores function, fitting the definition of a therapeutic device.
No
The TETRIS™ Spinal Implant is a physical implant designed to replace resected vertebral bodies. Its description focuses on its structural properties, materials, and surgical use, not on assessing or diagnosing medical conditions.
No
The device description clearly states it is a "hollow, rectangular frame with lateral fenestrations" forged from a titanium alloy, indicating it is a physical implant, not software.
Based on the provided information, the TETRIS™ Spinal Implant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to replace a vertebral body in the thoracolumbar spine due to tumor or trauma/fracture. This is a surgical implant used directly within the body.
- Device Description: The device is a physical implant made of titanium alloy, designed to be surgically placed.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The TETRIS™ Spinal Implant does not perform any such function.
Therefore, the TETRIS™ Spinal Implant is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TETRIS™ Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5).
The TETRIS™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixations systems that may be used with the TETRIS™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and Profile).
Product codes
MQP
Device Description
The TETRIS™ Spinal Implant is a hollow, rectangular frame with lateral fenestrations. The upper and lower aspects of the implants are open and the walls feature spikes, which assist in the positive anchorage and seating of the implants between the superior and inferior vertebral bodies. The frame is forged from a titanium alloy (Ti6Al4V).
The TETRIS™ Spinal Implant is available in a variety of sizes and a wedge shaped option. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The TETRIS™ may be used individually or paired based on anatomy and amount of bone resected by the surgeon. When using two implants, care should be taken not to mix flat and wedged shaped devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (from T1 to L5)
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)
Functional and safety testing of the TETRIS™ Spinal Implant consisted of mechanical testing in accordance with the "Guidance for Industry and FDA staff, Guidance for Spinal System 510(k)s. The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 0 8 2003
:
K022793
page 1 of 2
SECTION 2. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Submitter: | SIGNUS Medical LLC
6713 Lakeway Drive
Chanhassen, MN 55317 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Thomas Hoghaug
Signus Medical LLC
6713 Lakeway Drive
Chanhassen, MN 55317 |
| Date Prepared: | February 4, 2003 |
| Trade Name: | TETRIS™ Spinal Implant |
| Classification Name:
and Number: | Vertebral Body Replacement
Class II, 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device(s): | The TETRIS™ Spinal Implant is substantially equivalent to
the Stackable Cage™ System, manufactured by DePuy
AcroMed (K001340 and K990148) and the Surgical
Titanium Mesh™ System, manufactured by DePuy
AcroMed (K003043). |
| Device Description: | The TETRIS™ Spinal Implant is a hollow, rectangular
frame with lateral fenestrations. The upper and lower
aspects of the implants are open and the walls feature
spikes, which assist in the positive anchorage and seating of
the implants between the superior and inferior vertebral
bodies. The frame is forged from a titanium alloy
(Ti6Al4V). |
| The TETRIS™ Spinal Implant is available in a variety of
sizes and a wedge shaped option. This enables the surgeon
to choose the size suited to the individual pathology and
anatomical condition. The TETRIS™ may be used
individually or paired based on anatomy and amount of
bone resected by the surgeon. When using two implants,
care should be taken not to mix flat and wedged shaped
devices. | |
| Intended Use: | The TETRIS™ Spinal Implant is indicated for use to
replace a vertebral body that has been resected or excised
due to tumor or trauma/fracture. The device is intended for
use as a vertebral body replacement in the thoracolumbar
spine (from T1 to L5).
The TETRIS™ Spinal Implant is intended for use with
supplemental internal fixation. The supplemental internal
fixations systems that may be used with the TETRIS™
Spinal Implant include, but are not limited to, DePuy
AcroMed titanium plate or rod systems (Kaneda SR,
University Plate, M-2, ISOLA, VSP, Moss, TiMX, and
Profile). |
| Functional and
Safety Testing | Functional and safety testing of the TETRIS™ Spinal
Implant consisted of mechanical testing in accordance with
the "Guidance for Industry and FDA staff, Guidance for
Spinal System 510(k)s. The results of the examination and
testing were successful and did not raise any issues of
safety and effectiveness of the device. |
| Conclusion: | The TETRIS™ Spinal Implant is substantially equivalent to
the Stackable Cage™ System (K001340 and K990148),
manufactured by DePuy AcroMed and the Surgical
Titanium Mesh™ System, manufactured by DePuy
AcroMed (K003043) based on the device's similarities in
materials, functional design and indications for use. |
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K022793
page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 8 2003
Mr. Thomas Hoghaug SIGNUS Medical LLC 6713 Lakeway Drive Chanhassen, MN 55317
K022793 Re:
Trade Name: TETRIS™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: February 4 and 7, 2003 Received: February 7 and 10, 2003
Dear Mr. Hoghaug:
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.
3
Page 2 - Mr. Thomas Hoghaug
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- . 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/dsma/dsmamain.html
Sincerely yours,
Mark N Miller
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
4
Indications for Use Page
Device Name: TETRIS™ Spinal Implant
Indications for Use: The TETRIS™ Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5).
The TETRIS™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixations systems that may be used with the TETRIS™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. McKenna
Division Sign-Off) Division of General, Restorative and Neurological Devices
022793 510(k) Number _