(228 days)
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).
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.
The provided text describes a 510(k) premarket notification for a medical device called the TETRIS™ Spinal Implant. The information focuses on regulatory approval and substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories are not applicable.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from "Functional and Safety Testing") | Reported Device Performance |
|---|---|
| Mechanical testing in accordance with "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." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The study involved mechanical testing, not a clinical test set with human data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on medical images or patient outcomes.
4. Adjudication Method
Not applicable. This was mechanical testing, not an assessment requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
Not applicable. This submission concerns a physical medical implant, not an AI-assisted diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device itself is a standalone implant.
7. The Type of Ground Truth Used
The ground truth used was based on mechanical engineering standards and validated testing protocols as outlined in the "Guidance for Spinal System 510(k)s."
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm requiring a training set. The device's design and manufacturing rely on established engineering principles and materials science.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, this is not an AI algorithm.
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APR 0 8 2003
:
K022793
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SECTION 2. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Submitter: | SIGNUS Medical LLC6713 Lakeway DriveChanhassen, MN 55317 |
|---|---|
| Contact Person: | Mr. Thomas HoghaugSignus Medical LLC6713 Lakeway DriveChanhassen, MN 55317 |
| Date Prepared: | February 4, 2003 |
| Trade Name: | TETRIS™ Spinal Implant |
| Classification Name:and Number: | Vertebral Body ReplacementClass II, 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device(s): | The TETRIS™ Spinal Implant is substantially equivalent tothe Stackable Cage™ System, manufactured by DePuyAcroMed (K001340 and K990148) and the SurgicalTitanium Mesh™ System, manufactured by DePuyAcroMed (K003043). |
| Device Description: | The TETRIS™ Spinal Implant is a hollow, rectangularframe with lateral fenestrations. The upper and loweraspects of the implants are open and the walls featurespikes, which assist in the positive anchorage and seating ofthe implants between the superior and inferior vertebralbodies. The frame is forged from a titanium alloy(Ti6Al4V). |
| The TETRIS™ Spinal Implant is available in a variety ofsizes and a wedge shaped option. This enables the surgeonto choose the size suited to the individual pathology andanatomical condition. The TETRIS™ may be usedindividually or paired based on anatomy and amount ofbone resected by the surgeon. When using two implants,care should be taken not to mix flat and wedged shapeddevices. | |
| Intended Use: | The TETRIS™ Spinal Implant is indicated for use toreplace a vertebral body that has been resected or exciseddue to tumor or trauma/fracture. The device is intended foruse as a vertebral body replacement in the thoracolumbarspine (from T1 to L5).The TETRIS™ Spinal Implant is intended for use withsupplemental internal fixation. The supplemental internalfixations systems that may be used with the TETRIS™Spinal Implant include, but are not limited to, DePuyAcroMed titanium plate or rod systems (Kaneda SR,University Plate, M-2, ISOLA, VSP, Moss, TiMX, andProfile). |
| Functional andSafety Testing | Functional and safety testing of the TETRIS™ SpinalImplant consisted of mechanical testing in accordance withthe "Guidance for Industry and FDA staff, Guidance forSpinal System 510(k)s. The results of the examination andtesting were successful and did not raise any issues ofsafety and effectiveness of the device. |
| Conclusion: | The TETRIS™ Spinal Implant is substantially equivalent tothe Stackable Cage™ System (K001340 and K990148),manufactured by DePuy AcroMed and the SurgicalTitanium Mesh™ System, manufactured by DePuyAcroMed (K003043) based on the device's similarities inmaterials, functional design and indications for use. |
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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.
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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
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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 _
§ 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.