(78 days)
Not Found
Not Found
No
The summary describes a mechanical implant system with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a temporary reconstruction system for patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. While it is used in a medical context, it serves a reconstructive purpose rather than directly treating a disease or condition in a therapeutic manner.
No
The device is described as an "adjustable height add-on system" for "temporary reconstruction" in patients undergoing tumor surgery. Its purpose is to physically replace a removed mandibular condyle, not to diagnose a condition.
No
The device description explicitly states it consists of physical components: a condylar head, screws, and fixation plates. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical reconstruction within the body (specifically, the mandibular condyle). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a physical implantable system (condylar head, screws, plates) used during surgery. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical implant or device, not an IVD.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
NEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular condyle
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes (USA) Condylar Head Add-on-System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a horizontal line underneath the word "SYNTHES".
ISEP - 5 2008
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen parkway | ||
| West Chester, PA 19380 | ||
| Contact: 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 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. | ||
| Intended Use: | 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). | ||
| Substantial Equivalence: | 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 |
1
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.
2
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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold black letters, with a circled symbol to the left of the word. There is a line underneath the word. To the right of the word is the handwritten text "K081747", with a line underneath it.
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