(78 days)
Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
The Synthes Condylar Head Add-on System is an adjustable height add-on system for use with the 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. It consists of a condylar head, 2 screws, and one of four (4) fixation plates, each with a different screw hole spacing that determines the height of the condylar head.
The provided documents do not contain information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
The documents are a 510(k) summary and an FDA clearance letter for the "Synthes (USA) Condylar Head Add-on-System - Modification". These documents focus on establishing substantial equivalence to a predicate device, an existing Synthes Condylar Head Add-on-System.
Specifically, the 510(k) summary states that "Documentation is provided which demonstrates the Synthes (USA) Condylar Head Add-on-System - Modification to be substantially equivalent to other legally marketed devices such as: Synthes (USA) Condylar Head Add-on-System." This implies that the device's acceptance is based on its similarity to an already approved device, rather than a new study proving specific performance metrics against defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
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ISEP - 5 2008
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1301 Goshen parkwayWest Chester, PA 19380Contact: Andrea M. Tasker(610) 719-6290 | |
| Device Name: | Synthes (USA) Condylar Head Add-on-System - Modification | |
| Classification: | 21 CFR 872.3960: Mandibular condyle prosthesis | |
| Predicate Devices: | Synthes (USA) Condylar Head Add-on-System | |
| Device Description: | The Synthes Condylar Head Add-on System is an adjustable heightadd-on system for use with the 2.4 mm Locking ReconstructionPlate System and MatrixMANDIBLE Plate System. It consists of acondylar head, 2 screws, and one of four (4) fixation plates, eachwith a different screw hole spacing that determines the height of thecondylar head. | |
| Intended Use: | Intended for temporary reconstruction in patients undergoingablative tumor surgery requiring the removal of the mandibularcondyle. This device is not for permanent implantation, for patientswith TMJ or traumatic injuries, or for treatment oftemporomandibular joint disease (TMD). | |
| Substantial Equivalence: | Documentation is provided which demonstrates the Synthes (USA)Condylar Head Add-on-System - Modification to be substantiallyequivalent to other legally marketed devices such as:Synthes (USA) Condylar Head Add-on-System |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2008
Ms. Andrea M. Tasker Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K081747
Trade/Device Name: Synthes (USA) Condylar Head Add-on System Regulation Number: Unclassified Regulation Name: None Regulatory Class: II Product Code: NEI Dated: June 16, 2008 Received: June 19, 2008
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.
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Page 2 - Ms. Tasker
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.
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) 276-0115. 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 the reporting 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 yours,
JK Vammels-Lindner foreh
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of l
2.0 Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes (USA) Condylar Head Add-on System
Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular This device is not for permanent implantation, for condyle. patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Prescription Use X (Per 21 CFR 801.109)
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, Offic içe Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K081247
§ 872.4770 Temporary mandibular condyle reconstruction plate.
(a)
Identification. A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.(b)
Classification. Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.