← Product Code [GWO](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO) · K072758 # SYNTHES (USA) 2.0MM TITANIUM T-PLATE (K072758) _Synthes (Usa) · GWO · Dec 18, 2007 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K072758 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [GWO](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO.md) - **Decision Date:** Dec 18, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5320 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use The Synthes (USA) 2.0mm Titanium T-Plate is intended for use in the reconstruction of the cranium (skull) following surgical decompression procedures of the posterior fossa or transcervical skull based approach, with or without duraplasty, including procedures to treat Chiari Type I Malformation. The plate design is also intended for use in non-load bearing fixation, including cranial bone fixation. The device is intended for single use only. ## Device Story T-shaped titanium plate; used with 2.0mm screws for cranial reconstruction and non-load bearing fixation. Implanted by surgeons during cranial decompression procedures (e.g., posterior fossa or transcervical approaches). Provides structural stabilization of cranial bone; intended for single use. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Material: Titanium. Configuration: T-shaped plate. Compatibility: 2.0mm screws. Application: Non-load bearing cranial fixation. Single-use. ## Regulatory Identification A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material. ## Predicate Devices - Bioplate Rigid Bone Plating System - Synthes Titanium Contourable Mesh Plates - Synthes Matrix Mandible Reconstruction Plate - Synthes Occipital-Cervical Plate ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 3.0 510(k) Summary ## K072758 Page 1 of 1 · | Sponsor: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380 | |----------|--------------------------------------------------------------------------------------------------------------------------------------| | | Contact: Andrea M. Tasker
Regulatory Affairs Manager
Phone: (610) 719-6920
Fax: (484) 356-9682
tasker.andrea@synthes.com | | | DEC 1 8 2007 | |--|--------------| |--|--------------| | Device Name: | Synthes (USA) 2.0mm Titanium T-Plate | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification: | Class II
21 CFR § 882.5320
Common Name: Preformed alterable cranioplasty plate
Product Code: GWO | | Predicate Device: | Bioplate Rigid Bone Plating System
Synthes Titanium Contourable Mesh Plates
Synthes Matrix Mandible Reconstruction Plate
Synthes Occipital-Cervical Plate | | Device Description: | The Synthes (USA) 2.0mm Titanium T-Plate is a T-shaped plate
configuration to be used with the Synthes 2.0mm screws. The plates
are manufactured in titanium and are intended for single use only. | | Intended Use: | The Synthes (USA) 2.0mm Titanium T-Plate is intended for use in the
reconstruction of the cranium (skull) following surgical
decompression procedures of the posterior fossa or transcervical skull
based approach, with or without duraplasty, including procedures to
treat Chiari Type I Malformation. The plate design is also intended
for use in non-load bearing fixation, including cranial bone fixation.
The device is intended for single use only. | | Substantial
Equivalence: | Documentation is provided which demonstrates that the Synthes
(USA) 2.0mm Titanium T-Plate is substantially equivalent to other
legally marketed devices such as the plates in the Bioplate Rigid
Bone Plating System, the Synthes Titanium Contourable Mesh
Plates and the Synthes Matrix Mandible Reconstruction Plate. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's head, body, and tail feathers. Public Health Service DEC 1 8 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Synthes (USA) % Ms. Andrea Tasker 1301 Goshen Parkway West Chester, PA 19380 Re: K072758 Trade/Device Name: Synthes (USA) 2.0mm Titanium T-Plate Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: II Product Code: GWO Dated: September 27, 2007 Received: September 28, 2007 Dear Ms. Tasker: 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. {2}------------------------------------------------ Page 2 - Ms. Andrea Tasker 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Mark N. Mullison Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use K072758 510(k) Number (if known): Device Name: Indications: Synthes (USA) 2.0mm Titanium T-Plate The Synthes (USA) 2.0mm Titanium T-Plate is intended for use in the reconstruction of the cranium (skull) following surgical decompression procedures of the posterior fossa or transcervical skull based approach, with or without duraplasty, including procedures to treat Chiari Type I Malformation. The plate design is also intended for use in non-load bearing fixation, including cranial bone fixation. The device is intended for single use only. Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K072758 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K072758](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K072758) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com