(96 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of physical components (plates, meshes, screws) and do not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a fixation system (plates, mesh, and screws) used to maintain the relative position of bony fragments or grafts, which is a supportive mechanical function, not a therapeutic treatment for disease or condition.
No
The device is a system of plates, screws, and meshes intended for surgical implantation to fix bone fragments and grafts, not to diagnose medical conditions.
No
The device description explicitly details physical components like plates, meshes, and screws made of titanium alloy and commercially pure titanium, which are hardware. The performance studies also focus on mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device description: The Synthes Dentoalveolar Bone Fixation System is a system of plates, meshes, and screws intended to be implanted intraorally to fix bone fragments and grafts.
- Intended Use: The intended use is for maintaining the relative position of and/or containing bony fragments, bone grafts, or bone graft substitutes in reconstruction of the jaw.
This device is an implantable medical device used for surgical fixation, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
Device Description
The Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw system intended to be implanted intraorally for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.
Screws
The System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws in lengths from 3 mm to 20 mm. Screws are offered with both self-tapping and self-drilling tips. Screws are manufactured from titanium alloy (Ti 6Al 7Nb).
Plates and Meshes
The System includes plates and meshes that come in a variety of configurations to accommodate various dentoalveolar defect sites. The plates attach to bone via titanium cortex screws. Plates and meshes are manufactured from commercially pure titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular areas, including the dentoalveolar ridge
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)
Clinical Testing Data: No clinical testing was performed to support this submission.
Non-Clinical Testing Data: Mechanical testing was performed to compare the titanium alloy screws to screws from the predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System. Testing was performed to measure resistance to axial pullout, shear strength, and safety factor during insertion (the ratio of failure torque to insertion torque).
Mechanical testing was used to compare the titanium plates to plates from the predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System. Testing was performed to measure load at 0.2% offset yield and bending strength.
Mechanical testing was used to compare the titanium mesh to the predicate Osteo-Mesh TM-300. Testing was performed to measure peak load, displacement at peak, load at 0.2% offset yield, bending stiffness, and bending strength.
Key results: The results of the non-clinical testing described above support substantial equivalence by demonstrating that the mechanical performance of the Synthes Dentoalveolar Bone Fixation System devices is equivalent to or better than the predicate devices.
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.
K980199, K983485, K984230, K021642, K030069, K033121
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
§ 872.4760 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
i.
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| 510(k) Summary | | | | | | Page 1 of 1
DEC 2 0 2010 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|-----------------------------|
| Date Prepared | December 6, 2010 | | | | | |
| Submitter | SYNTHES (USA)
1301 Goshen Parkway
West Chester, PA 19380
United States of America | | | | | |
| Contact | Contact: Alan T. Haley
haley.alan@synthes.com
(484) 356-9763 | | | | | |
| Trade Name | Synthes Dentoalveolar Bone Fixation System | | | | | |
| Common Name | Bone plates and screws | | | | | |
| Classification
Name | Bone plate, Class II, 21 CFR 872.4760
Intraosseous fixation screw or wire, Class II, 21 CFR 872.4880 | | | | | |
| Product Codes | Primary: JEY
Subsequent: DZL | | | | | |
| Predicate Devices | • Synthes 1.5mm/2.0mm Orthognathic Maxillary Plates and Screws (K980199)
• Synthes 1.3 mm Self-Drilling Screw (K983485)
• Osteo-Mesh TM-300 (K984230)
• Synthes Craniofacial Plates (K021642)
• Synthes Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System
(K030069)
• 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates (K033121) | | | | | |
| Device
Description | The Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw
system intended to be implanted intraorally for use in non-load bearing
applications for maintaining the relative position of and/or containing bony
fragments, bone grafts (autograft or allograft), or bone graft substitutes in
reconstruction of maxillary and/or mandibular areas, including the dentoalveolar
ridge.
Screws
The System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws in
lengths from 3 mm to 20 mm. Screws are offered with both self-tapping and self-
drilling tips. Screws are manufactured from titanium alloy (Ti 6Al 7Nb). | | | | | |
Plates and Meshes
The System includes plates and meshes that come in a variety of configurations to accommodate various dentoalveolar defect sites. The plates attach to bone via titanium cortex screws. Plates and meshes are manufactured from commercially pure titanium.
102656
Page 1 of 2
(continued on next page)
1
® SYNTHES®
バ
: ﺰ
510(k) Summary (continued)
. '
| Intended Use | The Synthes Dentoalveolar Bone Fixation System is intended for use in non-load
bearing applications for maintaining the relative position of and/or containing
bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in
reconstruction of maxillary and/or mandibular areas, including the dentoalveolar
ridge. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The Synthes Dentoalveolar Bone Fixation System devices are similar to the
predicate devices in terms of indications, mechanical properties, dimensions,
principles of operation, and design (i.e. screws, plates, and mesh). |
| | The titanium used in the Synthes Dentoalveolar Bone Fixation System is used in
all of the predicate devices with the exception of the Poly (L-Lactide-Co-
Glycolide) Resorbable Fixation System. The non-clinical testing data discussed
below show that the subject devices have equivalent or better mechanical
performance when compared to the predicate devices and that the difference in
material does not raise new issues of safety and effectiveness. |
| Clinical Testing
Data | No clinical testing was performed to support this submission. |
| Non-Clinical
Testing Data | Mechanical testing was performed to compare the titanium alloy screws to screws
from the predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System.
Testing was performed to measure resistance to axial pullout, shear strength, and
safety factor during insertion (the ratio of failure torque to insertion torque). |
| | Mechanical testing was used to compare the titanium plates to plates from the
predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System. Testing
was performed to measure load at 0.2% offset yield and bending strength. |
| | Mechanical testing was used to compare the titanium mesh to the predicate Osteo-
Mesh TM-300. Testing was performed to measure peak load, displacement at
peak, load at 0.2% offset yield, bending stiffness, and bending strength. |
| | The results of the non-clinical testing described above support substantial
equivalence by demonstrating that the mechanical performance of the Synthes
Dentoalveolar Bone Fixation System devices is equivalent to or better than the
predicate devices. |
| Substantial
Equivalence to
Predicate Devices | In conclusion, the Synthes Dentoalveolar Bone Fixation System has the same
intended use as, and technological characteristics similar to, the legally marketed
predicate devices. Non-clinical testing data demonstrate that differences in the
technological characteristics do not raise new issues of safety or effectiveness.
The information presented supports substantial equivalence of the Synthes
Dentoalveolar Bone Fixation System to the predicate devices. |
(end of summary)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Alan T. Haley CMF Regulatory affairs specialist SYNTHES (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
DEC 2 0 2010
Re: K102656
Trade/Device Name: Synthes Dentoalveolar Bone Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 6, 2010 Received: December 7, 2010
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.
3
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/CDRH/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.
Into
Anthony D. Watson, B.S., M.S., M.B.A. Director . Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| SYNTHES® | |
|---|---|
| 2.0 Indications for Use | DEC 2 0 2010 |
| 510(k) Number (if known): | |
| Device Name: | Synthes Dentoalveolar Bone Fixation System |
| INDICATIONS FOR USE: | The Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge. |
| Prescription Use (Per 21 CFR 801.109) | X |
| 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, Office of Device Evaluation (ODE)
Susan Reeme
(Division Sign-Off) (Division Sign-Ult)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antonion Dental Devices
510(k) Number: K182257