(29 days)
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).
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.
The provided text is a 510(k) summary for the Curved PEEK Tetris™ Spinal Implant. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria through clinical trials or performance testing.
Therefore, the input does not contain information on acceptance criteria, a study that proves the device meets specific criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.
The document primarily focuses on establishing substantial equivalence based on similarities in:
- Intended Use: Used to replace a vertebral body resected due to tumor or trauma/fracture in the thoracolumbar spine (T1 to L5), with supplemental internal fixation.
- Operating Principle: Not explicitly detailed beyond being a vertebral body replacement.
- Basic Design: Hollow, slightly curved frame with tapered edges, open upper and lower aspects, and walls featuring spikes for anchorage.
- Materials: PEEK (PEEK-OPTIMA™ LT1) with Titanium alloy (TiAl6V4) marker pins.
- Surgical Techniques and Equipment: Same as the predicate device.
- Supplemental Internal Fixation Systems: Same as the predicate device (e.g., DePuy AcroMed titanium plate or rod systems).
- Manufacturing Environment, Sterilization Process, and Packaging Configurations: Same as the predicate device.
Conclusion stated in the document: The Curved PEEK Tetris™ is substantially equivalent to the predicate device, PEEK Tetris™ (cleared under K031757), based on functional design, indication for use, principles of operation, materials, and performance characteristics.
Since the provided text does not contain the information requested in the prompt regarding acceptance criteria, studies, and data specific to performance validation, I cannot fill out the requested table or provide those details. The 510(k) process relies on demonstrating equivalence to an existing device, rather than providing new performance data against specific acceptance criteria for a novel device.
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KO41888
ﺗﺄ
510(k) Summary
| Submitter: | SIGNUS Medizintechnik GMBHRannenbergring 54Alzennau, Germany D-63755 | |
|---|---|---|
| Contact Person: | Tracy L. Gray, RN, BS RACSenior ConsultantAlquest, Inc.Phone: (763) 588-9873 Fax: (763) 287-3836 | |
| Date Prepared: | July 9, 2004 | |
| Trade Name: | Curved PEEK Tetris™ | |
| ClassificationName andNumber: | 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 curvedframe with tapered edges. The upper and lower aspects of the implantare open and the walls feature spikes which assist in the positiveanchorage and seating of the implant between the superior and inferiorvertebral bodies.The frame is forged from PEEK (PEEK-OPTIMA™ LT1), which isradiolucent, and incorporates small Titanium alloy (TiAl6V4) markerpins so the device can be located within the body. The marker pinsmeet ASTM F-136 and ISO 5832/3.The Curved PEEK Tetris™ Spinal Implant is available in a variety ofsizes ranging from 7mm to 48mm. This enables the surgeon to choosethe 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 toreplace a vertebral body that has been resected or excised due to tumoror trauma/fracture. The device is intended for use as a vertebral bodyreplacement in the thoracolumbar spine (from T1 to L5) and is intendedfor use with supplemental internal fixation.The Curved PEEK Tetris ™ may be implanted singularly or in pairs. | |
| Statement ofTechnologicalComparison | The supplemental internal fixation systems that may be used with theCurved PEEK Tetris™ Spinal Implant is the same as the PEEK TetrisSpinal Implant and include, but are not limited to, DePuy AcroMedtitanium 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 supplementalinternal fixation systems;The same manufacturing environment;The same sterilization process; andThe 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
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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.
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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
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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
§ 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.