(238 days)
Synthes (USA) Locking Reconstruction Plate with Condylar Head is 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 Locking Reconstruction Plate with Condylar Head is a one piece reconstruction plate with a solid condylar head. The plate features compression screw holes that are internally threaded to accept the 2.4 - 3.0 mm locking screws or standard 2.4 mm self-tapping cortex screws and has notched sides and undersides to facilitate contouring. The plates are available in three sizes for right and left placement.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is primarily a 510(k) submission letter and a summary of safety and effectiveness information for a medical device (Synthes (USA) Locking Reconstruction Plate with Condylar Head). It details the device's description, intended use, classification, and regulatory status, but it does not include details on performance acceptance criteria or study results to demonstrate those criteria were met.
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001 22 1999
- Summary of Safety and Effectiveness Information 3.0
R990687
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Angela Silvestri |
|---|---|
| DEVICE NAME: | Synthes (USA) Locking Reconstruction Plate with Condylar Head |
| CLASSIFICATION: | 21 CFR 872.4760 Bone Plate |
| PREDICATE DEVICE: | Synthes (USA) Locking Reconstruction Plate System |
| DEVICE DESCRIPTION: | The Locking Reconstruction Plate with Condylar Head is a one piecereconstruction plate with a solid condylar head. The plate featurescompression screw holes that are internally threaded to accept the 2.4 - 3.0mm locking screws or standard 2.4 mm self-tapping cortex screws and hasnotched sides and undersides to facilitate contouring. The plates areavailable in three sizes for right and left placement. |
| INTENDED USE: | Synthes (USA) Locking Reconstruction Plate with Condylar Head isintended for temporary reconstruction in patients undergoing ablative tumorsurgery requiring the removal of the mandibular condyle. This device is notfor permanent implantation, for patients with TMJ or traumatic injuries, orfor treatment of temporomandibular joint disease (TMD). |
| MATERIAL: | Titanium |
Synthes (USA) LRP with Condylar Head 510(k) Confidential
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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 & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Public Health Service
APR 28 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela J. Silvestri Manager, Regulatory Affairs SYNTES (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K990637
Trade/Device Name: Synthes (USA) Locking Reconstruction Plate (LRP) with Condylar Head Regulation Number: 21 CFR 872.3960(c)(2) Regulation Name: Mandibular Condyle Prosthesis Regulatory Class: III Product Code: NEI Dated: July 23, 1999 Received: July 26, 1999
Dear Ms. Silvestri:
This letter corrects our substantially equivalent letter of October 22, 1999.
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. Silvestri
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Susan Cane
Susan Runner, D.D.S., M.A. Acting 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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2.0 Indications for Use Statement
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| Page | 1 of 1 |
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| 510(k) Number (if known): | K990637 |
| Device Name: | Synthes (USA) Locking Reconstruction Plate with Condylar Head |
| Indications/Contraindications: | Synthes (USA) Locking Reconstruction Plate with Condylar Head is 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). |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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| --------------------------------------- | ---- | ---------------------- |
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number | |
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Synthes (USA) LRP with Condylar Head 510(k) Confidential
§ 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.