Bonebridge Osteosynthesis Plating System

{0}------------------------------------------------ September 2, 2022 Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Bonebridge AG % Sandra Soniec Managing Director meditec Consulting GmbH Obermoosstrasse 23 Boll, Berne 3067 Switzerland Re: K213864 Trade/Device Name: Bonebridge Osteosynthesis Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: August 3, 2022 Received: August 4, 2022 Dear Sandra Soniec: 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. 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 {1}------------------------------------------------ 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 (QS) 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, Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213864 Device Name Bonebridge Osteosynthesis Plating System Indications for Use (Describe) The SALGINA® 2.5mm Volar Distal Radius System is indicated for - · Intra-articular fractures of the Distal Radius - · Extra-articular fractures of the Distal Radius The CASCELLA® 3.5mm Superior Clavicle System is indicated for: - fixation of fractures of the clavicle shaft - · fixation of fractures of the lateral clavicle - malunions of the clavicle - · non-unions of the clavicle The TAMINA® and TAMINA®TF Proximal Humerus System is indicated for: · Dislocated two-, three-, and four fractures of the proximal humerus including fractures involving osteopenic bone. - · Pseudarthroses (non-unions) of the proximal humerus - · Osteotomies of the proximal humerus The POYA® 3.5mm Lateral Proximal Tibia System is indicated for the internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including: - simple fractures - · comminuted fractures - · lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures - · depression fractures - · periprosthetic fractures - · nonunions, malunions, tibial osteotomies and osteopenic bone The POYA® 3.5mm Posteromedial Tibia System is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal areas of the tibia. The DALVAZZA® 2.5mm Distal Ulna System is indicated for - · fixation of fractures - nonunions of the distal ulna. The LEPORELLO® 3.5mm Olecranon System is indicated for - fractures - · osteotomies - non-unions of the olecranon and proximal ulna. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary In accordance with 21 CFR 807.92 the following information is provided for the Bonebridge Osteosynthesis Plating System. ADMINISTRATIVE INFORMATION | Date prepared | December 03, 2021 | |---------------------|-----------------------------------------------------------------------------------------------------------------------------| | Submission type: | Traditional 510(k) | | Purpose of 510(k): | Modification of currently cleared device K203002<br>Line Extension | | Submitter | Bonebridge AG<br>Bahnhofstrasse 11<br>6300 Zug<br>Switzerland | | Official Contact | Christof Gerber<br>CEO, Bonebridge AG | | Alternative Contact | Sandra Soniec<br>Senior consultant, meditec Consulting GmbH<br>Phone: +41 31 535 3193<br>Email soniec@meditec-consulting.ch | | US agent | Viky Verna, confinis corporation<br>Email: viky.verna@confinis.com | # DEVICE NAME AND CLASSIFICATION | Trade name: | Bonebridge Osteosynthesis Plating System | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Variants, types: | SALGINA 2.5mm Volar Distal Radius System<br>CASCELLA 3.5mm Superior Clavicle System<br>TAMINA 3.5mm Proximal Humerus System<br>POYA 3.5mm Lateral Proximal Tibia System<br>POYA 3.5mm Posteromedial Tibia System<br>DALVAZZA 2.5mm Distal Ulna System<br>LEPORELLO 3.5mm Olecranon System | | Common name: | Plate, Fixation, Bone | | Regulation number: | 21 CFR 888.3030 | | Classification name: | Single/multiple component metallic bone fixation<br>appliances and accessories | {5}------------------------------------------------ | Regulatory class: | Class II | | |---------------------------------------------------|---------------------------------------------------------------------|--------------------------------| | Product Code: | HRS | | | PREDICATE DEVICES | | | | Primary predicate device: | Bonebridge Osteosythesis Plating System (K203002) | TRIFT 3.5mm 1/3 Tubular System | | Additional predicate devices: | | | | SALGINA 2.5mm Volar Distal Radius System | Medartis APTUS 2.5 TriLock Distal Radius Fracture Plate | | | | K142906, K051567 APTUS® Wrist 2.5 System | | | CASCELLA 3.5mm Superior Clavicle System | SYNTHES LCP Superior Clavicle Plate 3.5mm | | | | K111540, K073186 Synthes 3.5mm LCP Clavicle Plate System | | | TAMINA 3.5mm Proximal Humerus System | SYNTHES PHILOS Proximal Humeral Plate 3.5mm | | | | K011815 Synthes LCP Proximal Humerous Plates (Standard) | | | POYA 3.5mm Lateral Proximal Tibia System (POYA-L) | SYNTHES 3.5 mm Variable Angle LCP Proxima Tibia Plate system | | | | K120689 SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM | | | POYA 3.5mm Posteromedial Tibia System (POYA-P) | SYNTHES 3.5mm LCP Posteromedial Tibia Plate | | | | K082624 SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES | | | DALVAZZA 2.5mm Distal Ulna System | SYNTHES 2.0mm LCP Distal Ulna Plate | | | | K092247 SYNTHES LOCKING HAND PLATES | | | LEPORELLO 3.5mm Olecranon System | SYNTHES VA-LCP Olecranon Plate | | | | K120070 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM | | ### INDICATIONS FOR USE The SALGINA® 2.5mm Volar Distal Radius System is indicated for - Intra-articular fractures of the Distal Radius - . Extra-articular fractures of the Distal Radius The CASCELLA® 3.5mm Superior Clavicle System is indicated for: - fixation of fractures of the clavicle shaft • {6}------------------------------------------------ - . fixation of fractures of the lateral clavicle - . malunions of the clavicle - . non-unions of the clavicle The TAMINA® and TAMINA®TF Proximal Humerus System is indicated for: - . Dislocated two-, three-, and four fragment fractures of the proximal humerus including fractures involving osteopenic bone. - Pseudarthroses (non-unions) of the proximal humerus - Osteotomies of the proximal humerus The POYA® 3.5mm Lateral Proximal Tibia System is indicated for is indicated for is indicated for the internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including: - . simple fractures - comminuted fractures - . lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures - . depression fractures - . periprosthetic fractures - . nonunions, malunions, tibial osteotomies and osteopenic bone The POYA® 3.5mm Posteromedial Tibia System is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal areas of the tibia. The DALVAZZA® 2.5mm Distal Ulna System is indicated for - . fixation of fractures - . nonunions of the distal ulna. The LEPORELLO® 3.5mm Olecranon System is indicated for - • fractures - . • osteotomies - . . non-unions of the olecranon and proximal ulna. ### DEVICE DESCRITION The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F899), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. {7}------------------------------------------------ All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surqical use. Non-clinical testing has demonstrated the devices are MR Conditional. #### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials and share similar design characteristics, including plate screw holes to accommodate locking and non-locking screws. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the predicate devices. The subject and predicate devices are sterilized by the standard methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy. #### SUMMARY OF PERFORMANCE DATA | Sterilization validation: | Gamma irradiation: The minimal dose of 25kGy is validated<br>using VDmax25 method as described in ISO 11137-2 and<br>confirmed a Sterility Assurance Level SAL of 10-6. | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Steam sterilization: Cleaning and sterilization procedures have<br>been successfully validated in accordance with ISO 17664 and<br>ISO 17665-1 at 132°C (270F) for 4 minutes and 20 min drying<br>time. | | Packaging validation: | Validation of the sterile packaging has been successfully<br>performed in accordance with ISO 11607 1/2 and ASTM<br>F1980. Furthermore, a transport simulation was conducted<br>according ISTA 2A followed by these packaging verification<br>tests:<br>Dye-Penetration, ASTM F1929 Visual inspection, ASTM F1886/1886M Seal strength, ASTM F88/F88M Microbial barrier testing, DIN 58953-6, Chapter 2.14 | | Mechanical testing: | Plates: Static and dynamic testing has been performed and<br>included statistical analysis and comparative testing to the<br>predicate devices. The predefined acceptance criteria were<br>successfully met. | | | Screws: Tested successfully in accordance with ASTM F543:<br>Standard Specification and Test Methods for Metallic Medical<br>Bone Screws an includes comparative testing to predicate<br>devices.<br><br>Design verification was successfully completed and included<br>compatibility of implants and instruments as well as<br>assessment of anatomical shape and appearance. | | MRI safety: | The Bonebridge Osteosythesis Plating System is MR<br>conditional considering local SAR based on the following tests Assessment of displacement force and torque effects in<br>the main static magnetic field at 3Tesla. Additionally, the<br>expected magnetic force in a stronger magnetic field<br>gradient of 30T/m was extrapolated. (According to ASTM<br>F2052-15 and ASTM F2213-17) Assessment of heating effects due to the RF-field during<br>MR scans at 1.5Tesla and 3Tesla according to ASTM<br>F2182-11a Assessment of image artifacts at 3Tesla according to<br>ASTM F2119-07 (2013) | | Usability: | Summative usability evaluation studies in accordance with IEC<br>62366-1 support that there are no significant usability issues<br>due to the study acceptance criteria of the primary objectives<br>prior Application/ Usability Risk Assessment update.<br>Therefore, the summative usability evaluation studies of the<br>Bonebridge Osteosythesis Plating System are considered as<br>successful. The study participants were able to use the<br>products safely and effectively. | | Clinical evaluation: | Based on the results of the literature review and the results of<br>verification and validation activities it has been concluded that<br>clinical investigations are not required, since surgical<br>technique, device design and material match established<br>interventions for the relevant indications. | #### Biocompatibility: A biological assessment has been performed in accordance with ISO 10993-1. {8}------------------------------------------------ # CONCLUSION The subject Bonebridge Osteosynthesis Plating System has similar indications, intended use, target populations, technological characteristics, and materials as the predicate devices. Non-clinical testing demonstrated that the performance of the proposed devices is equivalent to the predicate devices.