(96 days)
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.
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.
This document is a 510(k) Summary for the Synthes Dentoalveolar Bone Fixation System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are focused on demonstrating "substantial equivalence" to predicate devices through non-clinical mechanical testing, rather than specific performance metrics directly tied to clinical outcomes. The performance is assessed comparatively.
| Acceptance Criteria (Defined by Comparison to Predicate Devices) | Reported Device Performance |
|---|---|
| Screws (vs. predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System screws): | |
| * Resistance to axial pullout equivalent or better | Performed mechanical testing to measure resistance to axial pullout. |
| * Shear strength equivalent or better | Performed mechanical testing to measure shear strength. |
| * Safety factor during insertion (ratio of failure torque to insertion torque) equivalent or better | Performed mechanical testing to measure safety factor during insertion. |
| Plates (vs. predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System plates): | |
| * Load at 0.2% offset yield equivalent or better | Performed mechanical testing to measure load at 0.2% offset yield. |
| * Bending strength equivalent or better | Performed mechanical testing to measure bending strength. |
| Mesh (vs. predicate Osteo-Mesh TM-300): | |
| * Peak load equivalent or better | Performed mechanical testing to measure peak load. |
| * Displacement at peak equivalent or better | Performed mechanical testing to measure displacement at peak. |
| * Load at 0.2% offset yield equivalent or better | Performed mechanical testing to measure load at 0.2% offset yield. |
| * Bending stiffness equivalent or better | Performed mechanical testing to measure bending stiffness. |
| * Bending strength equivalent or better | Performed mechanical testing to measure bending strength. |
| Overall Conclusion: | The results of the non-clinical testing demonstrate that the mechanical performance of the Synthes Dentoalveolar Bone Fixation System devices is equivalent to or better than the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of screws, plates, or mesh samples) used for each mechanical test. It only states that "Mechanical testing was performed."
- Data Provenance: The data is from non-clinical testing, meaning it was conducted in a laboratory setting. There is no information provided about the country of origin. This is not retrospective or prospective in the clinical sense, as it’s bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies solely on non-clinical mechanical testing, not expert-established ground truth from clinical or imaging data. Therefore, no experts were involved in establishing ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. As this is mechanical testing, there is no need for an adjudication method for human interpretation or consensus. The "ground truth" is determined by the physical properties measured in the lab.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical testing was performed to support this submission." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical implant (bone plates and screws), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on objective mechanical property measurements obtained through non-clinical laboratory testing. This includes measurements like resistance to axial pullout, shear strength, load at yield, bending strength, peak load, and bending stiffness. The "truth" is the measured physical performance.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model. There is no concept of a "training set" for physical components. The design and manufacturing processes are likely informed by engineering principles and standards, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The mechanical properties are inherent to the material and design, and are validated through testing against established engineering standards and predicate device performance.
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| 510(k) Summary | Page 1 of 1DEC 2 0 2010 | |||||
|---|---|---|---|---|---|---|
| Date Prepared | December 6, 2010 | |||||
| Submitter | SYNTHES (USA)1301 Goshen ParkwayWest Chester, PA 19380United States of America | |||||
| Contact | Contact: Alan T. Haleyhaley.alan@synthes.com(484) 356-9763 | |||||
| Trade Name | Synthes Dentoalveolar Bone Fixation System | |||||
| Common Name | Bone plates and screws | |||||
| ClassificationName | Bone plate, Class II, 21 CFR 872.4760Intraosseous fixation screw or wire, Class II, 21 CFR 872.4880 | |||||
| Product Codes | Primary: JEYSubsequent: 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) | |||||
| DeviceDescription | The Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screwsystem intended to be implanted intraorally for use in non-load bearingapplications for maintaining the relative position of and/or containing bonyfragments, bone grafts (autograft or allograft), or bone graft substitutes inreconstruction of maxillary and/or mandibular areas, including the dentoalveolarridge.ScrewsThe System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws inlengths 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.
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® SYNTHES®
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510(k) Summary (continued)
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| Intended Use | The Synthes Dentoalveolar Bone Fixation System is intended for use in non-loadbearing applications for maintaining the relative position of and/or containingbony fragments, bone grafts (autograft or allograft), or bone graft substitutes inreconstruction of maxillary and/or mandibular areas, including the dentoalveolarridge. |
|---|---|
| TechnologicalCharacteristics | The Synthes Dentoalveolar Bone Fixation System devices are similar to thepredicate 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 inall of the predicate devices with the exception of the Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System. The non-clinical testing data discussedbelow show that the subject devices have equivalent or better mechanicalperformance when compared to the predicate devices and that the difference inmaterial does not raise new issues of safety and effectiveness. | |
| Clinical TestingData | No clinical testing was performed to support this submission. |
| Non-ClinicalTesting Data | Mechanical testing was performed to compare the titanium alloy screws to screwsfrom the predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System.Testing was performed to measure resistance to axial pullout, shear strength, andsafety factor during insertion (the ratio of failure torque to insertion torque). |
| Mechanical testing was used to compare the titanium plates to plates from thepredicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System. Testingwas 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 atpeak, load at 0.2% offset yield, bending stiffness, and bending strength. | |
| The results of the non-clinical testing described above support substantialequivalence by demonstrating that the mechanical performance of the SynthesDentoalveolar Bone Fixation System devices is equivalent to or better than thepredicate devices. | |
| SubstantialEquivalence toPredicate Devices | In conclusion, the Synthes Dentoalveolar Bone Fixation System has the sameintended use as, and technological characteristics similar to, the legally marketedpredicate devices. Non-clinical testing data demonstrate that differences in thetechnological characteristics do not raise new issues of safety or effectiveness.The information presented supports substantial equivalence of the SynthesDentoalveolar Bone Fixation System to the predicate devices. |
(end of summary)
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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.
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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
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| 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
§ 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.