(59 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of the plates and screws, with no mention of AI or ML capabilities.
Yes
The device is described as a "Plate and Screw System" intended for surgical procedures such as reconstructive and orthognathic surgery, indicating its direct role in repairing or reconstructing anatomical structures, which is a therapeutic function.
No
The device is a system of plates and screws intended for surgical repair and correction, not for identifying or assessing medical conditions.
No
The device description clearly states it consists of physical plates and screws made of titanium or titanium alloy, which are hardware components.
Based on the provided information, the DePuy Synthes MatrixMANDIBLE Plate and Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical procedures (oral, maxillofacial surgery, trauma, reconstructive surgery, orthognathic surgery). IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a system of plates and screws made of titanium or titanium alloy, intended for implantation in the body. This is characteristic of a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used with biological specimens, reagents, or for diagnostic purposes based on analyzing samples.
Therefore, the DePuy Synthes MatrixMANDIBLE Plate and Screw System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only.
The Synthes MatrixMANDIBLE screws that are the subject of this submission are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of 2.4 mm and lengths ranging from 26-40mm, and have a thread pitch of 1.0 mm. These screws work with all plates within the MatrixMANDIBLE Plate and Screw system.
These devices are offered non-sterile and must be sterilized before use. MatrixMANDIBLE screws are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, maxillofacial
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)
Non-clinical Performance Testing:
Testing was performed per ASTM F543 to compare the proposed DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE screws to the reference device. This information supports that the mechanical performance of the subject devices is at least non-inferior to that of the reference device.
Sterilization adoption evaluated the subject device design and materials and confirmed that the subject device does not present a new worst case and can therefore be adopted under existing Moist Heat sterilization validation.
Packaging validation demonstrates that the bag LDPE on roll or PE tubing for the non-sterile version of the subject device can protect the non-sterile device during distribution and ensure product integrity.
Biocompatibility evaluation confirms that the non-sterile packaged version of the subject device meets the requirements of ISO 10993-1 and that the proposed devices intended for direct contact with the human body present no toxicological risk.
Clinical Performance Data:
Clinical data was not necessary for the determination of substantial equivalence.
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 MatrixMANDIBLE Plate and Screw System (K063790)
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.
Synthes Mandibular Modular Fixation System (K954385), Synthes MatrixMANDIBLE Plate and Screw System (K121574)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 10, 2020
Prem Pisupati Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K201944
Trade/Device Name: DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: August 10, 2020 Received: August 11, 2020
Dear Prem Pisupati:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201944
Device Name
DePuy Synthes 2.4 mm Ti Self-Tapping MatrixMANDIBLE Screws (26 - 40mm)
Indications for Use (Describe)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Sponsor | DePuy Synthes
Prem Pisupati
1301 Goshen Parkway
West Chester, PA USA
Phone: 610-719-1019 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | September 10, 2020 |
| Proprietary
Name | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE screws (26-40mm) |
| Common Name | Bone Plate |
| Classification | Class II
Regulation Number: 21 CFR 872.4760
Product Code: JEY |
| Predicate Device | Synthes MatrixMANDIBLE Plate and Screw System (K063790) |
| Reference
Device | Synthes Mandibular Modular Fixation System (K954385)
Synthes MatrixMANDIBLE Plate and Screw System (K121574) |
| Reason for
Submission | To introduce a non-sterile packaged version of the 2.4mm Ti Self-Tapping
MatrixMANDIBLE screws additional lengths (26mm - 40mm). |
| Device
Description | The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety
of plates offered in multiple shapes and sizes and a variety of screws offered in
multiple diameters and lengths to meet the anatomical needs of the patient.
System implants are manufactured in either titanium or titanium alloy and are
intended for single use only. |
| | The Synthes MatrixMANDIBLE screws that are the subject of this submission
are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of
2.4 mm and lengths ranging from 26-40mm, and have a thread pitch of 1.0 mm.
These screws work with all plates within the MatrixMANDIBLE Plate and
Screw system. |
| | These devices are offered non-sterile and must be sterilized before use.
MatrixMANDIBLE screws are intended for single use only. |
| Indications for
use | The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for
oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic
surgery (surgical correction of dentofacial deformities) |
| Contraindications | - Acute or chronic, local or systemic infections
- Allergy to implant material
- Insufficient bone quality to secure the implant |
| Comparison to
Predicate | The subject device has the same intended use as the predicate device. The
intended use of the subject system is a subset of the intended use of the reference
device. |
| | The subject devices, predicate device and the reference device are metallic plates
with a low-profile design intended for bone fracture fixation. Both subject,
predicate and reference devices are compatible with the same screw types. |
| | The subject and predicate devices are made from Titanium Alloy (TAN). |
| | The subject devices present the following features that are not similar in the
reference device: |
| | • Reference devices have a slightly larger screw head diameter and thread
diameter than the subject devices |
| | • Reference devices core diameter is lower than the subject devices |
| | • Reference devices are manufactured from commercially pure Titanium,
while the subject devices are manufactured from Titanium Alloy (TAN) |
| | |
| Non-clinical
Performance
Testing | Testing was performed per ASTM F543 to compare the proposed DePuy Synthes
2.4mm Ti Self-Tapping MatrixMANDIBLE screws to the reference device. This
information supports that the mechanical performance of the subject devices is at
least non-inferior to that of the reference device. |
| | Sterilization adoption evaluated the subject device design and materials and
confirmed that the subject device does not present a new worst case and can
therefore be adopted under existing Moist Heat sterilization validation. |
| | Packaging validation demonstrates that the bag LDPE on roll or PE tubing for the
non-sterile version of the subject device can protect the non-sterile device during
distribution and ensure product integrity. |
| | Biocompatibility evaluation confirms that the non-sterile packaged version of the
subject device meets the requirements of ISO 10993-1 and that the proposed
devices intended for direct contact with the human body present no toxicological
risk. |
| Clinical
Performance
Data | Clinical data was not necessary for the determination of substantial equivalence. |
| Substantial | The subject device has the same indications for use, design, and material of
manufacture as the predicate device. The subject devices will be available in |
| Equivalence | longer lengths than the predicate devices.
The summary of verification and validation activities included in this submission support that the addition of a non-sterile version of the 2.4mm Ti Self-Tapping MatrixMANDIBLE screws do not raise any issues regarding safety and effectiveness.
It is concluded that the information provided in this submission supports substantial equivalence. |
510(k) Summary
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