SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM

K102656 · Synthes (Usa) · JEY · Dec 20, 2010 · Dental

Device Facts

• Record ID: K102656
• Device Name: SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Dec 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The Synthes Dentoalveolar Bone Fixation System consists of titanium alloy cortex screws (1.3 mm, 1.5 mm, 2.0 mm) and commercially pure titanium plates and meshes. The system is used intraorally by surgeons to stabilize bone fragments or graft materials during reconstruction of the maxillary and mandibular regions, including the dentoalveolar ridge. The device functions as a mechanical fixation system; plates and meshes are secured to bone using the cortex screws. It is intended for non-load bearing applications. The system provides structural support to maintain the position of bone grafts or fragments, facilitating healing and reconstruction. No software or algorithms are involved.

Clinical Evidence

No clinical testing was performed to support this submission. Substantial equivalence is supported by non-clinical mechanical testing comparing the subject device to predicate devices, including measurements of axial pullout, shear strength, failure torque, bending strength, and bending stiffness.

Technological Characteristics

System components include cortex screws (titanium alloy Ti 6Al 7Nb) and plates/meshes (commercially pure titanium). Screws are available in 1.3 mm, 1.5 mm, and 2.0 mm diameters with self-tapping or self-drilling tips. The system is a mechanical fixation device; no energy source, software, or connectivity features are present.

Indications for Use

Indicated for patients requiring reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge, for the purpose of maintaining the relative position of or containing bony fragments, bone grafts, or bone graft substitutes in non-load bearing applications.

Regulatory Classification

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.

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)

Submission Summary (Full Text)

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| 510(k) Summary | | | | | | Page 1 of 1<br>DEC 2 0 2010 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|-----------------------------|
| Date Prepared | December 6, 2010 | | | | | |
| Submitter | SYNTHES (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>United States of America | | | | | |
| Contact | Contact: Alan T. Haley<br>[e-mail]<br>[phone] | | | | | |
| Trade Name | Synthes Dentoalveolar Bone Fixation System | | | | | |
| Common Name | Bone plates and screws | | | | | |
| Classification<br>Name | Bone plate, Class II, 21 CFR 872.4760<br>Intraosseous fixation screw or wire, Class II, 21 CFR 872.4880 | | | | | |
| Product Codes | Primary: JEY<br>Subsequent: DZL | | | | | |
| Predicate Devices | • Synthes 1.5mm/2.0mm Orthognathic Maxillary Plates and Screws (K980199)<br>• Synthes 1.3 mm Self-Drilling Screw (K983485)<br>• Osteo-Mesh TM-300 (K984230)<br>• Synthes Craniofacial Plates (K021642)<br>• Synthes Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System<br>(K030069)<br>• 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates (K033121) | | | | | |
| Device<br>Description | The Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw<br>system intended to be implanted intraorally for use in non-load bearing<br>applications for maintaining the relative position of and/or containing bony<br>fragments, bone grafts (autograft or allograft), or bone graft substitutes in<br>reconstruction of maxillary and/or mandibular areas, including the dentoalveolar<br>ridge.<br><br>Screws<br>The System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws in<br>lengths from 3 mm to 20 mm. Screws are offered with both self-tapping and self-<br>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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#### 510(k) Summary (continued)

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| Intended Use | The Synthes Dentoalveolar Bone Fixation System is intended for use in non-load<br>bearing applications for maintaining the relative position of and/or containing<br>bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in<br>reconstruction of maxillary and/or mandibular areas, including the dentoalveolar<br>ridge. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The Synthes Dentoalveolar Bone Fixation System devices are similar to the<br>predicate devices in terms of indications, mechanical properties, dimensions,<br>principles of operation, and design (i.e. screws, plates, and mesh). |
| | The titanium used in the Synthes Dentoalveolar Bone Fixation System is used in<br>all of the predicate devices with the exception of the Poly (L-Lactide-Co-<br>Glycolide) Resorbable Fixation System. The non-clinical testing data discussed<br>below show that the subject devices have equivalent or better mechanical<br>performance when compared to the predicate devices and that the difference in<br>material does not raise new issues of safety and effectiveness. |
| Clinical Testing<br>Data | No clinical testing was performed to support this submission. |
| Non-Clinical<br>Testing Data | Mechanical testing was performed to compare the titanium alloy screws to screws<br>from the predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System.<br>Testing was performed to measure resistance to axial pullout, shear strength, and<br>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<br>predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System. Testing<br>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-<br>Mesh TM-300. Testing was performed to measure peak load, displacement at<br>peak, load at 0.2% offset yield, bending stiffness, and bending strength. |
| | The results of the non-clinical testing described above support substantial<br>equivalence by demonstrating that the mechanical performance of the Synthes<br>Dentoalveolar Bone Fixation System devices is equivalent to or better than the<br>predicate devices. |
| Substantial<br>Equivalence to<br>Predicate Devices | In conclusion, the Synthes Dentoalveolar Bone Fixation System has the same<br>intended use as, and technological characteristics similar to, the legally marketed<br>predicate devices. Non-clinical testing data demonstrate that differences in the<br>technological characteristics do not raise new issues of safety or effectiveness.<br>The information presented supports substantial equivalence of the Synthes<br>Dentoalveolar 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 [phone] or [phone] 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) |

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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