Argulated Locking Plates

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 1, 2015 OsteoMed L.P. Ms. Anita Zacherl Senior Regulatory Specialist 3885 Arapaho Road Addison, TX 75001 Re: K143338 Trade/Device Name: OsteoMed ICON Modular Locking Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 27, 2015 Received: March 2, 2015 Dear Ms. Zacherl: 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. {1}------------------------------------------------ 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 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/Resourcesfor You/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 vours. Tina Kiang -S for 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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Osteomed. The logo is in blue and green, with the word "OSTEOMED" in large, bold letters. The logo has a swoosh design above and below the text. The swoosh above the text is blue, and the swoosh below the text is green. # Indications for Use K143338 510(k) Number (if known): _ Device Name: OsteoMed ICON Modular Locking Fixation System Indications for Use: The OSTEOMED ICON Modular Locking Fixation System is indicated for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The OSTEOMED ICON Angulated Locking Plate System implants and drills are intended for single use only. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold, blue letters. The logo has a blue swoosh above the word and a gray swoosh below the word. There is a registered trademark symbol in the upper right corner of the logo. # Special 510(k) Summary | Name of Submitter: OsteoMed | | |-----------------------------|------------------------------------------------------| | | 3885 Arapaho Road | | | Addison, Texas 75001 | | | Phone: (972) 677-4600 | | | Fax: (972) 677-4601 | | Contact Person: | Anita Zacherl | | Date Prepared: | March 30, 2015 | | Device Proprietary Name: | OsteoMed ICON Modular Locking Fixation System | | Device Common Name: | ICON Locking Fixation System | | Classification Name: | 21 CFR 872.4760, Plate, Bone | | Product Code: | JEY | | Predicate Devices: | OsteoMed Modular Locking Fixation System,<br>K080694 | | Classification Name: | Plate, bone (21CFR 872.4760,<br>Product Code JEY) | | | Device Class: II | Summary: # Device Description: The OSTEOMED ICON Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of maxillofacial and mandibular fractures. The screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard non-locking screws, safety screws and Auto-Drive™ screws, as needed. OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 {4}------------------------------------------------ The system features three modular blocks. - . The 1.6mm Midface System consists of 1.6mm locking standard screws with lengths ranging from 3mm to 14mm, 1.6mm locking Auto-Drive™ screws with lengths ranging from 4mm to 8mm and 1.9mm safety screws with lengths ranging from 3mm to 1.6mm midface plates range in thicknesses of 0.6mm to 0.8mm. - . The 2.0mm Midface/Mandible System consists of 2.0mm locking standard screws with lengths 4mm to 18mm, 2.0mm locking Auto-Drive™ screws with lengths of 4mm to 8mm, and 2.3mm safety screws with lengths ranging from 4mm to 24mm. The midface plates range in thicknesses of 0.6mm to 0.8mm and the mandible plates range in thicknesses of 1.0mm to 1.5mm. - The 2.8mm Mandible System consists of 2.0mm locking standard screws with lengths 6mm to 22mm, 2.4mm locking Auto-Drive™ screws with lengths of 6mm to 8mm, and 2.7mm safety screws with lengths ranging from 6mm to 22mm. The fracture plates range in thicknesses of 1.0mm to 1.5mm and the reconstruction plates range in thicknesses of 2.0mm to 2.8mm. The instruments include drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates. # Indications for Use: The OSTEOMED ICON Modular Locking Fixation System is indicated for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The OSTEOMED ICON Modular Locking Fixation System implants and drills are intended for single use onlv. # Technological Characteristics: The OsteoMed ICON Modular Locking Fixation System is recommended for fixation of maxillofacial and mandibular fractures. The ICON Modular Locking Fixation System screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade plastic, the same materials used in the manufacture of the predicate devices. These materials are biocompatible. # Performance/Clinical Data: The OsteoMed ICON Modular Locking Fixation System 2.8mm plates were compared to the OsteoMed 2.5mm Modular Locking Fixation System plates, K080694. The ICON Modular Locking Fixation OsteoMed 3885 Arapaho Road Addison, Texas 75001 (973) 677-4600 FAX: (972) 677-4601 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The logo is surrounded by a blue and gray oval shape. The logo is simple and modern, and it is likely used to represent the company's brand. System plates underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use of the OsteoMed ICON Modular Locking Fixation System plates is the same as the OsteoMed Modular Locking Fixation System plates. Performance equivalence was shown through the verification comparison to the predicate devices. Clinical Testing is not required to support substantial equivalence. # Substantial Equivalence: A design, dimensional, and performance comparison was performed to establish substantial equivalence to the legally marketed predicate devices listed in this summary. The basis of substantial equivalence for this device is based on similarities in intended use, material, function, performance, design, technology and operational principles to the OsteoMed Modular Locking Fixation System (K080694). | Comparison Table Modular Locking Fixation Mandible Module | | | | |-----------------------------------------------------------|----------------------------------------|---------------------------------------|--| | System / Device | OSTEOMED ICON Modular | OSTEOMED Modular Locking | | | Name | Locking Fixation Mandible | Fixation System Mandible | | | | Module Reconstruction Plates | Module Reconstruction Plates | | | 510K Number | Pending | K080694 | | | Classification | Class II | Class II | | | | 21 CFR 872.4760 | 21 CFR 872.4760 | | | | JEY | JEY | | | Indication for | The OsteoMed ICON Modular | The OsteoMed Modular Locking | | | Use | Locking Fixation System is indicated | Fixation System is indicated for | | | | for fracture fixation in maxillofacial | fracture fixation in cranio- | | | | trauma reconstruction, mandibular | maxillofacial trauma reconstruction, | | | | reconstruction and orthognathic | mandibular reconstruction and | | | | reconstruction. | orthognathic reconstruction. | | | | The implants and drills are intended | The implants and drills are intended | | | | for single use only. | for single use only. | | | Plates | Various shapes | Various shapes | | | Recon Plate | 2.8mm | 2.5mm | | | Thickness | | | | | Material (Recon | ASTM F-67 | ASTM F-67 | | | Plates) | | | | | The 2.4mm | • 2.4mm locking standard screws | • 2.4mm locking standard screws | | | Mandible | with lengths 6mm to 22mm | with lengths 6mm to 22mm | | | Module | · 2.4mm locking Auto-Drive™ | · 2.4mm locking Auto-Drive™ | | | Screw Sizes and | screws with lengths of 6mm to 8mm | screws with lengths of 6mm to 8mm | | | Lengths | | | | | Instruments | The instruments include drill bits, | The instruments include drill bits, | | | | plate bending pliers, plate holding | plate bending pliers, plate holding | | | | forceps, plate cutters, drill guides, | forceps, plate cutters, drill guides, | | | | cannulae, taps, countersinks, and | cannulae, taps, countersinks, and | | {6}------------------------------------------------ | Comparison Table Modular Locking Fixation Mandible Module | | | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System / Device<br>Name | OSTEOMED ICON Modular<br>Locking Fixation Mandible<br>Module Reconstruction Plates | OSTEOMED Modular Locking<br>Fixation System Mandible<br>Module Reconstruction Plates | | | screwdrivers to facilitate the<br>placement of screws and modification<br>of plates. | screwdrivers to facilitate the<br>placement of screws and<br>modification of plates. | | Technology | Locking Plates and Screws to fixate<br>bone | Locking Plates and Screws to fixate<br>bone | | Principles of<br>Operation | Angulated Locking for Rigid Fixation | Angulated Locking for Rigid Fixation | | Features | Various Plates and Screws | Various Plates and Screws | | Plates<br>(shape) | Variety of shapes and sizes (e.g.,<br>straight, angled right, angled left,<br>contoured with various size holes).<br>Plates can be modified/contoured and<br>cut to length | Variety of shapes and sizes (e.g.,<br>straight, angled right, angled left,<br>contoured with various size holes).<br>Plates can be modified/contoured and<br>cut to length | | Plate holes | Angled Locking/Locking | Angled Locking/Locking | The basis of substantial equivalence of the OsteoMed ICON Modular Locking Fixation System to the OsteoMed Modular Locking Fixation System, K080694, is based on the similarities in design, technology, material, function, sterilization, and intended use. OsteoMed believes that the nonclinical tests demonstrate that the device is substantially equivalent to the predicate devices. OsteoMed 3885 Arapaho Road Addison, Texas 75001 (974) 677-4600 FAX: (972) 677-4601