(182 days)
No
The device description focuses on patient-specific design based on CT data and surgical plans, with no mention of AI or ML for analysis, planning, or manufacturing.
Yes.
The device is used for internal fixation of maxillofacial bone following trauma or reconstructive surgery, which directly addresses an injury or condition to facilitate healing and restore function.
No
The device is a metallic bone plate used for internal fixation in maxillofacial surgery, which is a therapeutic function, not diagnostic.
No
The device description explicitly states that the device is a "metallic bone plate" and is "manufactured from commercially pure titanium." This indicates a physical hardware component, not a software-only device. While software is likely used in the design process based on CT scan data, the final medical device is a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Synthes Patient Specific Plates are a metallic bone plate intended for internal fixation of bone in the maxillofacial region. It is a surgical implant used within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states surgical procedures (oral and maxillofacial surgery, trauma and reconstructive surgery) and specific bone fixation applications.
- Device Description: The description details a physical implantable device, not a diagnostic test kit or instrument.
Therefore, the Synthes Patient Specific Plates fall under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Synthes Patient Specific Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery.
Specific Indications for Use:
- Primary mandibular reconstruction with bone graft
- Temporary bridging until delayed secondary reconstruction
- Secondary mandibular reconstruction
- Comminuted mandibular fractures
- Fractures of edentulous and/or atrophic mandibles
- Unstable mandibular fractures
- Maxillary reconstruction with or without bone graft
- Maxillary trauma
Product codes
JEY
Device Description
Synthes Patient Specific Plates are a metallic bone plates used in conjunction with metallic bone screws for the internal fixation of maxillofacial bone, specifically in the areas of the mandible and maxilla. The design and dimensions (number and placement of holes, hole angulation, plate length, etc.) of each plate are based on of the patient's anatomic (CT scan) data, the surgical plan, and input from the surgeon. Synthes Patient Specific Plates are not intended to be further bent or contoured during surgery. Synthes Patient Specific Plates are manufactured from commercially pure titanium, are provided non-sterile, must be sterilized prior to use, and are intended for single use only.
The proposed device has a constant thickness along the entirety of the plate length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
maxillofacial bone, specifically in the areas of the mandible and maxilla.
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)
Bench testing was used to demonstrate that any differences, where they do exist, do not negatively impact safety and effectiveness.
A cross-sectional analysis compared the in-plane resistance to bending of the proposed and predicate devices. The bending resistance of the proposed plates was determined to be equivalent or better to the predicate devices. Therefore, it is concluded that the proposed plates do not raise any new questions of safety or efficacy in terms of bending resistance.
Mechanical testing compared the cantilever bend fatigue life of the proposed and predicate devices. The fatigue life of the proposed plates was determined to be equivalent or better to the predicate devices. Therefore, it is concluded that the proposed plates do not raise any new questions of safety or efficacy in terms of cantilever bend fatigue life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
510(k) Sümmary 5
Page 1 of 3
FEB 2 8 2013
| Date Prepared | February 15, 2013 |
|---|---|
| Submitter | Synthes (USA) |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact | Alan T. Haley |
| haley.alan@synthes.com | |
| (484) 356-9763 | |
| Device Name | Synthes Patient Specific Plates |
| Classification Name | Class II |
| Regulation: | 21 CFR 872.4760 |
| Product Code | JEY |
| Common Name: | Bone Plate |
Predicate Devices
- . Synthes MatrixMANDIBLE Plating System (K063790)
- Synthes MatrixMANDIBLE Preformed Reconstruction Plates (K091144) .
Indications for Use
Synthes Patient Specific Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery.
Specific Indications for Use:
- . Primary mandibular reconstruction with bone graft
- . Temporary bridging until delayed secondary reconstruction
- ◆ Secondary mandibular reconstruction
- � Comminuted mandibular fractures
- Fractures of edentulous and/or atrophic mandibles .
- . Unstable mandibular fractures
- Maxillary reconstruction with or without bone graft .
- Maxillary trauma .
Device Description
Synthes Patient Specific Plates are a metallic bone plates used in conjunction with metallic bone screws for the internal fixation of maxillofacial bone, specifically in the areas of the mandible and maxilla. The design and dimensions (number and placement of holes, hole angulation, plate length, etc.) of each plate are based on of the patient's anatomic (CT scan) data, the surgical plan, and input from the surgeon. Synthes Patient Specific Plates are not intended to be further bent or contoured during surgery. Synthes Patient Specific Plates are manufactured from commercially pure titanium, are provided non-sterile, must be sterilized prior to use, and are intended for single use only.
1
VATHES
5 510(k) Summary
Comparison to Predicate Devices
Indications
The Indications statement for the proposed device and both predicate devices includes use in oral and maxillofacial surgery, trauma, and reconstructive surgery. Both the proposed device and predicate Synthes MatrixMANDIBLE Preformed Reconstruction Plate list specific Indications for Use in addition to the more general intended use statement. All of the specific Indications for the proposed device are within the scope of the general use of the device.
The differences in the Indications statement for the proposed device in comparison to the predicates do not constitute a new intended use.
Technological Similarities
- The proposed device and the predicate devices share fundamental principle of operation -. metallic plates used in conjunction with metallic screws for oral and maxillofacial surgery, trauma, and reconstructive surgery.
- . The proposed device and the predicate devices are manufactured from commercially pure titanium, which meets the requirements of ASTM standard F67. Titanium has a long, established history of use as a surgical implant material.
- . The proposed device is offered in thicknesses of 2.0 mm and 2.5 mm. The thicknesses of the predicate devices range from 2.0 mm to 2.8 mm.
- . The proposed device and both predicate devices feature the same screw hole geometry and are compatible. with all previously cleared MatrixMANDIBLE bone screws.
- . The proposed device and both predicate devices can be cut intraoperatively.
- The proposed plate and both predicates are compatible with the Synthes Condylar Head Add-on-. System (K081747).
- The proposed device has a constant thickness along the entirety of the plate length. The body section . of the predicate MatrixMANDIBLE Preformed Reconstruction plates has a similar constant thickness.
Technological Differences
- The angles and dimensions of each Synthes Patient Specific Plate are determined based on the patient . anatomy and surgical plan and should not be further contoured intraoperatively. The predicate Synthes MatrixMANDIBLE Reconstruction plate is flat and is intended to be contoured intraoperatively to the required shape. The ramus and symphysis sections of the predicate Synthes MatrixMANDIBLE Preformed Reconstruction Plate are intraoperatively contoured to the required shape.
- . The proposed device has a constant thickness along the plate length. The predicate Synthes MatrixMANDIBLE Reconstruction Plates and the ramus and symphysis sections of the predicate Synthes MatrixMANDIBLE Preformed Reconstruction plates have bending notches and resulting variations.
2
C SYNTHES
5 510(k) Summary
Non-clinical performance data
Bench testing was used to demonstrate that any differences, where they do exist, do not negatively impact safety and effectiveness.
A cross-sectional analysis compared the in-plane resistance to bending of the proposed and predicate devices. The bending resistance of the proposed plates was determined to be equivalent or better to the predicate devices. Therefore, it is concluded that the proposed plates do not raise any new questions of safety or efficacy in terms of bending resistance.
Mechanical testing compared the cantilever bend fatigue life of the proposed and predicate devices. The fatigue life of the proposed plates was determined to be equivalent or better to the predicate devices. Therefore, it is concluded that the proposed plates do not raise any new questions of safety or efficacy in terms of cantilever bend fatigue life.
Clinical performance data
Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence
The proposed device has the same intended use as the predicate devices. The bench testing included in this submission demonstrates that the differences in technological characteristics do not raise any new questions of safety and effectiveness. The information submitted supports substantial equivalence.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2013
Mr. Alan Haley Regulatory Affairs Specialist Synthes, Incorporated 1301 Goshen Parkway WEST CHESTER PA 19380
Re: K122647
Trade/Device Name: Synthes Patient Specific Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 15, 2013 Received: February 19, 2013
Dear Mr. Haley:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Mr. Haley
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Image /page/4/Picture/7 description: The image shows the name "Kwame O. Ulmer" in a stylized font. The first name, "Kwame," is written in a simple, bold typeface. The middle initial and last name, "O. Ulmer," are incorporated into a geometric design, with the letters forming a pattern of concentric shapes and lines. To the right of the name, the word "for" is written in a smaller, plain font.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized figure inside. A horizontal line is present below the word, adding emphasis to the brand name. The overall impression is a strong and recognizable brand identity.
Indications for Use Statement 4
510(k) Number (if known): ___
Device Name:
Synthes Patient Specific Plates
Indications for Use:
Synthes Patient Specific Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery.
Specific Indications for Use:
- Primary mandibular reconstruction with bone graft ●
- Temporary bridging until delayed secondary reconstruction ●
- Secondary mandibular reconstruction .
- Comminuted mandibular fractures .
- Fractures of edentulous and/or atrophic mandibles ●
- Unstable mandibular fractures .
- Maxillary reconstruction with or without bone graft .
. :: i
- Maxillary trauma �
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mary S. Runner -S | |
|---|---|
| Susan Runner, DDS, MA 2013.02.28 | |
| 09:58:05 -05'00' |
Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K122647 |
|---|---|
| ---------------- | --------- |
Synthes Patlent Specific Plate