(164 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI or ML.
Yes
The device is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies and temporary stabilization to maintain proper occlusion during bone fixation and healing, which aligns with the definition of a therapeutic device.
No
The device is described as a system for temporary fixation of mandibular and maxillary fractures and osteotomies, which is a treatment function, not a diagnostic one.
No
The device description explicitly details physical components made of titanium and titanium alloy (plates, screws), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the MatrixWAVE MMF System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the temporary treatment of mandibular and maxillary fractures and osteotomies. This is a surgical/mechanical intervention on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a bone-borne fixation system consisting of plates and screws. This is a physical implant/device used to stabilize bone, not a reagent, instrument, or system used to examine specimens from the human body.
- No mention of diagnostic testing: The description focuses on the mechanical function and application of the device for fracture fixation and healing. There is no mention of analyzing biological samples or providing diagnostic information.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The MatrixWAVE MMF System does not fit this description.
N/A
Intended Use / Indications for Use
The MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
Product codes
JEY
Device Description
MatrixWAVE MMF is a bone-borne maxillomandibular fixation (MMF) system that consists of wave shaped plates (made from commercially pure Titanium) that are attached to the dental arches with self-drilling locking screws (made from Titanium alloy, Ti-6Al-7Nb). The system is intended for temporary stabilization of mandibular and maxillary fractures and osteotomies to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (approximately 6-8 weeks). The dental arches are brought into occlusion by wiring around the plate hooks and/or accessible screw heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular and maxillary
Indicated Patient Age Range
adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
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)
Non-clinical testing and analyses comparing the proposed devices to the predicate within this submission includes: Mechanical Construct Testing, Screw Testing, Corrosion Testing, Hook Testing, and Biocompatibility Testing according to ISO 10993-18:2005. The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixWAVE MMF System is comparable to that of the predicate.
Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human profiles. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5,2014
Synthes (USA) Products LLC Damon Lees Senior Manager, Regulatory Affairs-CMF 1302 Wrights Lane East West Chester, PA 19380
Re: K141165
Trade/Device Name: Matrix WAVE MMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 29, 2014 Received: September 2, 2014
Dear Mr. Lees:
This letter corrects our substantially equivalent letter of October 17, 2014.
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno, DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4 Indications for Use Statement
510(k) Number (if known): K141165
Device Name:
MatrixWAVE MMF System
Indications for Use:
The MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
Prescription Use × (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)
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Image /page/3/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, black letters on the right. There is a registered trademark symbol to the upper right of the word "SYNTHES". A horizontal line is located at the bottom of the logo.
5 510(k) Summary
Page 1 of 2
| Date Prepared: | October 14, 2014 |
|---|---|
| Submitter: | Synthes (USA) Products LLC |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact: | Damon Lees |
| lees.damon@synthes.com |
(610) 719-5608 (610) 719-6533 (fax)
MatrixWAVE MMF System Device Name:
Device Classification Information
| Product Code | Device Name | Device Class | Regulation Number | Regulation Description |
|---|---|---|---|---|
| JEY | Plate, Bone | 2 | 21 CFR | |
| 872.4760 | Bone plate |
In addition to the above type of implants, The MatrixWAVE MMF System also includes accessory items such as stainless steel wire and surgical instruments which are not the subject of this submission.
Predicate Device:
- Stryker Universal SMARTLock Hybrid MMF System (K122313) .
Indications for Use:
The MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
Device Description:
MatrixWAVE MMF is a bone-borne maxillomandibular fixation (MMF) system that consists of wave shaped plates (made from commercially pure Titanium) that are attached to the dental arches with self-drilling locking screws (made from Titanium alloy, Ti-6Al-7Nb). The system is intended for temporary stabilization of mandibular and maxillary fractures and osteotomies to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (approximately 6-8 weeks). The dental arches are brought into occlusion by wiring around the plate hooks and/or accessible screw heads.
Comparison to Predicate Devices:
Indications
The MatrixWAVE MMF System has the same general Indications for Use as the predicate device.
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5 510(k) Summary (continued)
Technological Similarities of the MatrixWAVE MMF System to Predicate
- Same general principle of operation: metallic plates and screws each fixated to the . mandible and maxilla, then wired together to achieve maxillomandibular fixation (MMF).
- Same or similar materials used for plates (Titanium), screws (Titanium alloy), and ● accessory wires (stainless steel).
- Compatible with similar diameter wires. ●
- Both use self-drilling screws with the same shaft (i.e. bone purchase) lengths. ●
- . Both have a locking plate/screw interface.
- Both have plates that can be cut & contoured. .
- Both have plates with pre-contoured hooks to support wires or elastics. .
- Both are provided non-sterile. .
Technological Differences of the MatrixWAVE MMF System to Predicate
- Screws in the proposed system have a smaller diameter. .
- Screws in the proposed system have a raised head with a groove to accommodate . wire(s) or elastics for additional (optional) stability.
- . The plate/screw interface of the proposed system has pre-machined threads within the plate and can accommodate off-axis screw placement.
- . The plates of the proposed system have a different shape, hole geometry, and dimensions.
- . The plates of the proposed system can be compressed/expanded to accommodate patient anatomy and/or the location of screw holes.
Non-Clinical Performance Data:
Non-clinical testing and analyses comparing the proposed devices to the predicate within this submission includes: Mechanical Construct Testing, Screw Testing, Corrosion Testing, Hook Testing, and Biocompatibility Testing according to ISO 10993-18:2005. The non-clinical performance data demonstrate that the mechanical performance of the proposed MatrixWAVE MMF System is comparable to that of the predicate.
Clinical Performance Data:
Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence:
The proposed system has the same general indications as the predicate system. The mechanical testing included in this submission demonstrates that:
- Any differences in technological characteristics of the predicate do not raise any new . questions of safety and effectiveness.
- . The proposed devices are at least as safe and effective as the predicate.
It is concluded that the information included in this submission supports substantial equivalence.