Who is the manufacturer of CURVED PEEK TETRIS SPINAL IMPLANT?

Signus Medizintechnik GmbH filed the 510(k) submission for CURVED PEEK TETRIS SPINAL IMPLANT (K041888).

What is the FDA product code for CURVED PEEK TETRIS SPINAL IMPLANT?

MQP. It is classified under 21 CFR 888.3060 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for CURVED PEEK TETRIS SPINAL IMPLANT?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like CURVED PEEK TETRIS SPINAL IMPLANT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CURVED PEEK TETRIS SPINAL IMPLANT

K041888 · Signus Medizintechnik GmbH · MQP · Aug 10, 2004 · Orthopedic

Device Facts

Record ID	K041888
Device Name	CURVED PEEK TETRIS SPINAL IMPLANT
Applicant	Signus Medizintechnik GmbH
Product Code	MQP · Orthopedic
Decision Date	Aug 10, 2004
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3060
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Curved PEEK Tetris™ is a hollow, slightly curved spinal implant with tapered edges and wall spikes for anchorage between vertebral bodies. Forged from radiolucent PEEK-OPTIMA™ LT1; incorporates Titanium alloy (TiAl6V4) marker pins for radiographic localization. Available in sizes 7mm to 48mm; implanted singularly or in pairs by surgeons in clinical settings. Device acts as a structural spacer to replace resected/excised vertebral bodies; requires supplemental internal fixation (e.g., titanium plate or rod systems) to stabilize the spinal segment. Benefits include structural support and restoration of spinal column integrity following tumor or trauma-related resection.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: PEEK-OPTIMA™ LT1; Titanium alloy (TiAl6V4) marker pins per ASTM F-136 and ISO 5832/3. Design: Hollow, curved frame with tapered edges and spikes. Dimensions: 7mm to 48mm. Energy: None (passive implant). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for vertebral body replacement in the thoracolumbar spine (T1-L5) following resection or excision due to tumor or trauma/fracture. Requires use with supplemental internal fixation.

Regulatory Classification

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.

Predicate Devices

PEEK Tetris™ (K031757)

Related Devices

K031757 — PEEK TETRIS SPINAL IMPLANT · Signus Medical, LLC · Jul 30, 2003
K051659 — SEMIAL SPINAL IMPLANT · Signus Medizintechnik GmbH · Jul 13, 2005
K043316 — RABEA SPINAL IMPLANT · Signus Medizintechnik GmbH · Feb 7, 2005
K050861 — PEEK CAS · Interpore Cross Intl. · May 27, 2005
K062132 — AVS PL PEEK SPACER SYSTEM · Stryker Spine · Aug 16, 2006

Submission Summary (Full Text)

{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