(54 days)
Not Found
No
The description focuses on the material, shape, and intended use of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an implant for vertebral body replacement, which is a structural and mechanical function, not a therapeutic action like drugs or radiation.
No
No
The device description clearly states it is a physical implant made of PEEK and Titanium alloy, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, the PEEK 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 spine due to tumor or trauma/fracture. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a physical implant made of PEEK and titanium, designed for structural support in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The PEEK Tetris™ Spinal Implant is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The PEEK 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 PEEK Tetris™ Spinal Implant is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the PEEK 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).
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The PEEK 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 PEEK which is radiolucent and incorporates Titanium alloy marker pins so the device can be located within the body. The PEEK 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.
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)
Representative samples of the device underwent testing to demonstrate comparable functional and performance characteristics to the predicate device.
The patient contact materials of the PEEK Tetris™ are processed in the same manner and are identical to those used in other legally marketed predicate devices from SIGNUS that have undergone appropriate biocompatibility testing. Therefore biocompatibility testing of the PEEK Tetris™ has been fulfilled by analogy to those devices.
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
K031757
Pi of 2
PEEK Tetris™
SIGNUS Medical LLC Special 510(k)
JUL 3 0 2003
Appendix F
510(k) Summary
| Submitter: | SIGNUS Medical LLC |
|---|---|
| 6713 Lakeway Drive | |
| Chanhassen, MN 55317 | |
| Contact Person: | Mr. Thomas Hoghaug |
| Managing Director | |
| Phone: (952) 974-9456 | |
| Fax: (952) 975-0465 | |
| Date Prepared: | June 3, 2003 |
| Trade Name: | PEEK Tetris™ |
| Classification Name | |
| and Number: | 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device | |
| Name and 510(k) | |
| Number | Titanium Tetris™ |
| K022793 | |
| Device Description: | DEVICE DESCRIPTION |
| The PEEK 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 PEEK which is radiolucent and incorporates Titanium | |
| alloy marker pins so the device can be located within the body. | |
| The PEEK 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. | |
| Intended Use: | The PEEK 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 PEEK TETRIST™ Spinal Implant is intended for use with | |
| supplemental internal fixation. | |
| The supplemental internal fixation systems that may be used | |
| with the PEEK 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). | |
| Statement of | |
| Technological | |
| Comparison | Representative samples of the device underwent testing to |
| demonstrate comparable functional and performance | |
| characteristics to the predicate device. | |
| The patient contact materials of the PEEK Tetris™ are | |
| processed in the same manner and are identical to those used in | |
| other legally marketed predicate devices from SIGNUS that | |
| have undergone appropriate biocompatibility testing. Therefore | |
| biocompatibility testing of the PEEK Tetris™ has been fulfilled | |
| by analogy to those devices. | |
| Conclusion: | The PEEK Tetris™ is substantially equivalent to the Titanium |
| Tetris™. This conclusion is based upon the fact that this device | |
| is substantially equivalent to the predicate device in terms of | |
| functional design, indications for use, principles of operation | |
| and test performance characteristics. |
1
PEEK Tetris™
.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized representation of three human figures, possibly representing individuals or families, under a protective wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
Mr. Thomas Hoghaug Managing Director SIGNUS Medical LLC 6713 Lakeway Drive Chanhassen, MN 55317
Re: K031757
Trade Name: PEEK Tetris™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 7, 2003 Received: July 8, 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) 594-4659. 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.
Sincerely yours,
Mark A. Mellar
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
Image /page/4/Picture/0 description: The image shows a sequence of characters and a trademarked name. The characters "K O 3 1 7" are followed by a stylized "5" and a "7". Below the characters, the text "PEEK Tetris™" is visible, indicating a product or brand name.
SIGNUS Medical LLC Special 510(k)
Appendix B
Indications for Use Statement
TBD 510(k) Number (if known)
Device Name PEEK Tetris™
The PEEK Tetris™ Spinal Implant is indicated for use to replace a Indications vertebral body that has been resected or excised due to tumor or for Use trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5).
The PEEK Tetris™ Spinal Implant is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the PEEK 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).
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109)
OR Over-The-Counter Use
[signature]
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number
Appendix B Page 1
06/03/03
CONFIDENTIAL