(29 days)
Not Found
No
The description focuses on the material, design, and intended use of a physical spinal implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a spinal implant used to replace resected vertebral bodies due to tumor or trauma/fracture, indicating its use in treating a medical condition.
No
This device is an implant used to replace a vertebral body, not to diagnose a condition.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for replacing a vertebral body due to tumor or trauma/fracture. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implant made of PEEK and titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant used to replace a damaged anatomical structure.
N/A
Intended Use / Indications for Use
The Curved 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) and is intended for use with supplemental internal fixation.
The Curved PEEK Tetris ™ may be implanted singularly or in pairs.
The supplemental internal fixation systems that may be used with the Curved PEEK Tetris™ Spinal Implant is the same as the Curved PEEK Tetris™ Spinal Implant and 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 Curved PEEK Tetris® Spinal implant is a hollow, slightly curved frame with tapered edges. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies.
The frame is forged from PEEK (PEEK-OPTIMA™ LT1), which is radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker pins so the device can be located within the body. The marker pins meet ASTM F-136 and ISO 5832/3.
The Curved PEEK Tetris™ Spinal Implant is available in a variety of sizes ranging from 7mm to 48mm. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The Curved PEEK Tetris™ may be implanted individually or in pairs.
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)
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
KO41888
ﺗﺄ
510(k) Summary
| Submitter: | SIGNUS Medizintechnik GMBH
Rannenbergring 54
Alzennau, Germany D-63755 | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Tracy L. Gray, RN, BS RAC
Senior Consultant
Alquest, Inc.
Phone: (763) 588-9873 Fax: (763) 287-3836 | |
| Date Prepared: | July 9, 2004 | |
| Trade Name: | Curved PEEK Tetris™ | |
| Classification
Name and
Number: | 21 CFR 888.3060 | |
| Product Code: | MQP | |
| Predicate Device | PEEK Tetris™ cleared under K031757 on 7/30/03. | |
| Device Description: | The Curved PEEK Tetris® Spinal implant is a hollow, slightly curved
frame with tapered edges. The upper and lower aspects of the implant
are open and the walls feature spikes which assist in the positive
anchorage and seating of the implant between the superior and inferior
vertebral bodies.
The frame is forged from PEEK (PEEK-OPTIMA™ LT1), which is
radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker
pins so the device can be located within the body. The marker pins
meet ASTM F-136 and ISO 5832/3.
The Curved PEEK Tetris™ Spinal Implant is available in a variety of
sizes ranging from 7mm to 48mm. This enables the surgeon to choose
the size suited to the individual pathology and anatomical condition.
The Curved PEEK Tetris™ may be implanted individually or in pairs. | |
| Intended Use: | The Curved 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) and is intended
for use with supplemental internal fixation.
The Curved PEEK Tetris ™ may be implanted singularly or in pairs. | |
| Statement of
Technological
Comparison | The supplemental internal fixation systems that may be used with the
Curved PEEK Tetris™ Spinal Implant is the same as the PEEK Tetris
Spinal Implant and 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 subject device have the following similarities:
• The same indication for use;
• The same operating principle;
• The same basic design; | |
| | The same materials;
Implanted using the same surgical techniques and equipment;
Used in conjunction with the same types of supplemental
internal fixation systems;
The same manufacturing environment;
The same sterilization process; and
The same packaging configurations.
In summary, the Curved PEEK Tetris™, as described in this submission is, in the opinion of Signus GMBH, substantially equivalent to the predicate device. | |
| Conclusion: | The Curved PEEK Tetris™ as modified in this submission, is substantially equivalent to the predicate device, PEEK Tetris™ cleared under K031757. This conclusion is based upon the similarities of the devices in terms of functional design, indication for use, principles of operation, materials, and performance characteristics. | |
AUG 1 0 2004
1
·
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a bird or eagle, with three curved lines representing its wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2004
SIGNUS Medizintechnik GMBH C/o Ms. Tracy L. Gray, RN, BS, RAC Senior Consultant Alquest Incorporated 4050 Olson Memorial Highway, Suite 350 Minneapolis, Minnesota 55422
Re: K041888
R041600
Trade/Device Name: Curved 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 11, 2004 Received: July 12, 2004
Dear Ms. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bection of the device is substantially equivalent (for the indications felerenced above und nave decembers and and marketed predicate devices marketed in interstate 101 use stated in the encrosure) to regars actment date of the Medical Device American be to Connices prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been roctasined in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mereloro, manot of the Act include requirements for annual registration, listing of general controls provisions of aactice, 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 If your device is classimod (500 a0070) as Existing major regulations affecting your device can may be subject to back as a sateral 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 I lease of advised that i Dristian that your device complies with other requirements of the Act that I DA has intace a and regulations administered by other Federal agencies. You must of any I catal statutes and regirements, including, but not limited to: registration and listing (21 Compry with an the Her 3 requirements, 01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms. Tracy L. Gray, RN, BS, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogin maniening of substantial equivalence of your device to a legally premarket notification: "The PDF intembly sification 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 If you desire specific acriosis - at (301) 594-4659. Also, please note the regulation entitled, Colliation of Compullier and (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation on Jour Copsumer 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,
R. Mark A. Millman
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
510(k) Number (if known): _ ← ○ 4 | 仓 名 용
Curved PEEK Tetris™ Spinal Implant Device Name:
Indications for Use:
The Curved 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) and is intended for use with supplemental internal fixation.
The Curved PEEK Tetris ™ may be implanted singularly or in pairs.
The supplemental internal fixation systems that may be used with the Curved PEEK Tetris™ Spinal Implant is the same as the Curved PEEK Tetris™ Spinal Implant and 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)
| Prescription Use
| (Per 21 CFR 801.109) | Or | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K041888 |
|---|---|
| --------------- | --------- |
| SIGNUS GMBH | Curved PEEK Tetris™ | Special 510(k) |
|---|---|---|
| ------------- | --------------------- | ---------------- |
07/09/2004
Curved PEEK Tetris
Appendix B Page 1