(81 days)
Not Found
Not Found
No
The 510(k) summary describes a passive, mechanical implant (a titanium plate) and makes no mention of AI, ML, image processing, or any software-driven functionality.
No
The device is a non-load bearing fixation plate used for reconstruction of the skull, which is an implantable structural component rather than a device that directly performs therapy.
No
The device is a titanium plate used for surgical reconstruction and fixation of the cranium, not for diagnosing medical conditions.
No
The device description explicitly states it is a "T-shaped plate configuration" manufactured in titanium, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Synthes 2.0mm Titanium T-Plate clearly state it is a physical implant used for the reconstruction and fixation of the skull. It is a surgical device, not a device that analyzes biological samples.
The information provided about the device's function, materials, and intended anatomical site all point to it being a surgical implant, not an IVD.
N/A
Intended Use / 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.
Product codes
GWO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium (skull), posterior fossa
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
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.(b)
Classification. Class II (performance standards).
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
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