Anatomical Plating System (various)

{0}------------------------------------------------ December 13, 2023 Image /page/0/Picture/1 description: The image shows 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 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. Tyber Medical, LLC. Lisa Boyle Director, Regulatory Affairs 83 South Commerce Way Suite 310 Bethlehem, Pennsylvania 18017 ### Re: K232652 Trade/Device Name: Anatomical Plating System (various) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 15, 2023 Received: November 15, 2023 ### Dear Lisa Boyle: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 -S 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K232652 Device Name Tyber Medical Anatomical Plating System #### Indications for Use (Describe) The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Frag System, Long Bone Fracture System, and Ankle Fracture/ Fusion System with the following indications: #### Mini-Frag System The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, malunions, replantations, and fusions of short bones and small fragments of bone including, but not limited to, the hand, wrist, foot, and ankle. The mini-frag system is also intended for reduction of non-load bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use. #### Foot System The Tyber Medical Foot System is indicated for fixation of fractures, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone in the foot (Phalanges and Metatarsals), and long bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) in an adult patient. The Tyber Medical Foot System is not for Spinal Use. Long Bone Fracture System The Tyber Medical Long Bone Fracture System is indicated for fixation of fractures, nonunions, nalunions, replantations, and fusions of the clavicle, scapula, olecranon, humerus, radius, ulna, fibula. The Tyber Medical Long Bone Fracture System is not for Spinal Use. #### Ankle Fracture/Fusion System Tyber Medical Ankle Fracture/Fusion System is indicated for use in: · Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, nonunions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; · In intra- and extra articular fractures, medial malleolar fractures and nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus; • In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle. The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use. #### Type of Use (Select one or both, as applicable) > 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 Prepared on: 2023-08-31 ## Contact Details 21 CFR 807.92(a)(1) | Applicant Name | Tyber Medical, LLC. | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------| | Applicant Address | 83 South Commerce Way Suite 310 Bethlehem PA 18017 United States | | | Applicant Contact Telephone | 610-295-7984 | | | Applicant Contact | Ms. Lisa Boyle | | | Applicant Contact Email | lboyle@tybermed.com | | | Device Name 21 CFR 807.92(a)(2) | | | | Device Trade Name | Tyber Medical Anatomical Plating System | | | Common Name | Plate, Fixation, Bone; Screw, Fixation, Bone | | | Classification Name | Single/multiple component metallic bone fixation appliances and accessories | | | | Smooth or threaded metallic bone fixation fastener | | | Regulation Number | 888.3030 (primary), 888.3040 (secondary) | | | Product Code | HRS /HWC | | | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | | | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K222465 | Anatomical Plating System | HRS | | K203817/K193222 | Anatomical Plating System | HRS | | K213591 | Anthem Fracture System | HRS | | Device Description Summary | | 21 CFR 807.92(a)(4) | | This traditional 510(k) is being completed to update the indications for use of the Tyber Medical Anatomical Plating System. There are no new implants or instruments being added to the system and no changes to the design, functionality, and application of the devices that | | | make up the system cleared under K222465. Device Description The Tyber Medical Anatomical Plating System consists of the following categories: - 1. Mini-frag System - 2. Foot System 3. Long Bone Fracture System 4. Ankle Fracture/Fusion System A brief and concise description of each system is as follows: Mini-frag System The Tyber Medical Mini-frag System offers a variety of bone fragments. The system incorporates a series of standard {5}------------------------------------------------ and locking compression plates and screws of varying lengths, thicknesses, and configurations including 1). Straight Fracture Plates, 2). T-shape Fracture Plates, 3). Y-shape Fracture Plates, 5). Cloverleaf plates, 6). Straight Fusion Plates, 7). Oblique Fracture Plates, 8). Oblique Fracture Compression Plates, 10). Zig-Zag Plates, 10). Zig-Zag Plates, 12). Mesh Plates The System will incorporate both Locking Screws and Non-Locking Screws in 2.0mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing. A full set of Ancillary instrumentation is available with the system. The Tyber Medical Mini-frag/Small Bone sterile and non-sterile for single-use. #### Foot System The Tyber Medical Foot System consists of a variety of plates with shapes and sizes designed for internal fixation of short bone fragments of the foot. The implants are designed to provide highly anatomic and versatile options and stabilizations of small bones in the feet. The plates are available in various lengths, with straight, right and left configurations. Plate types consist of 1). TMT-1 Fusion Plates, 2). Open Wedge Plates, 3). Navicular Plates, 5). Lateral Talar Neck Plates, 6). Akin Plates, 7). 5th Metatarsal Jones Fracture Plates, 8), 5th Metatarsal Fracture Compression Plates, 9), 5th Metatarsal Avulsion Fracture Plates, 10). Medial Talar Neck Plates, 11). Distal Medial Column Plates, 13). ORIF Standard Calcaneal Plates, 14). Rectangular Plates, 15). X-Plates, 16). Cotton Plates, 17). Dwyer Plates, 19). MTP Fusion Revision Plates, 20). Stepped Lapidus Plates, 21, Plantar TMT Plates, 22). Medial Column Plates, 24, TMT-I Medial Fusion Plates, 25). Sinus Tarsi Plates, 26). 1st 2nd Ray Lisfranc Joint Plates, 27). 2nd and 3rd Ray Lisfranc Joint Plates, 28). Navicular Cuneiform Plates, 30). Talonavicular Plates. The system will incorporate both locking and Nor-locking screws. All plates are composed of T-6A-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing. A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Foot System is offerile and non-sterile for single-use. #### Long Bone Fracture System The Tyber Medical Long Bone Fracture System consists of a straight low contact locking plate and a 1/3 locking tubular plate. The system will incorporate both Cortical locking and standard Cortical Non-locking screws. All plates are composed of Ti-6Al-4VELL (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of T-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing. A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Long Bone Fracture System is offered both sterile and non-sterile for single-use. #### Ankle Fracture/Fusion System The Tyber Medical Ankle Fracture/Fusion is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system is composed of various locking plate types which include 1). Posterior Tibia Plate, 2). Fibula Plate, 3). Medial Tibia Plate, 5). Anterolateral Tibia Plate, 7). Medial Malleolus Plate, 7). Medial Malleous Plate, 8). Fibula Hook Plate, Straight, 9). Fibula Hook Plate, Anatomic, 10). Anterior TT Plate, 12). Anterolateral TT Plate, 13). Lateral TT Plate, 14). Lateral TTC Plate, 15). Posterior TTC Plate, 17). Posteromedial Tibia Plate, 18). Trimalleolar Plate, 19). Trimalleolar Plate, 19, Posterior Fibular Plate. The System will incorporate both Locking Screws and Non-locking Screws in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing. A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Ankle Fracture/Fusion System is offered both sterile and non-sterile for single-use. ## Intended Use/Indications for Use ### 21 CFR 807.92(a)(5) The intended use of the Tyber Medical Anatomical Plating System is to bridge or otherwise stabilize bone fragments together in order to facilitate healing. It is composed of the Mini-Frag System, Long Bone Fracture System, and Ankle Fracture/ Fusion System with the following indications: {6}------------------------------------------------ Mini-frag System: The Tyber Medical Mini-Frag is indicated tor fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including, but not limited to, the hand, wrist, foot, and ankle. The mini-frag system is also infended for reduction and stabilization of non-bad bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use. Foot System The Tyber Medical Foot System is indicated for fixation of fractures, osteotomies, malunions, replantations, and fusions of short bones and small fragments of bone in the foot (Phalanges and Metatarsals), and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) in an adult patient. The Tyber Medical Foot System is not for Spinal Use. Long Bone Fracture System The Tyber Medical Long Bone Fracture System is indicated for fixation of fractures, ostectomies, nonunions, replantations, and fusions of the clavicle, scapula, olecranon, huma, fibula. The Tyber Medical Long Bone Fracture System is not for Spinal Use. Ankle Fracture/Fusion System The Tyber Medical Ankle Fracture/Fusion System is indicated for use in: · Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, nonunions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; • In intra- and extra articular fractures, medial malleolar fractures and nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus; • In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle. The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use. ### Indications for Use Comparison The indications for use are similar in both the subject and predicate device(s). ## Technological Comparison The subject device has similar indications for use as the predicate devices identified above. There are no design, functionality, performance or technological changes to the devices that make up the Tyber Medical Anatomical Plating System. #### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) This submission is for an indication change only to the Tyber Medical Anatomical Plating System. There are no changes to the devices, and therefore, there is no change in performance of the device. No new implants are being introduced in this submission. These devices remain the same as the devices cleared from K222465. No clinical testing was performed. The Tyber Medical Anatomical Plating System is substantially equivalent to the indications for use of the already marketed predicate devices. There are no new implants or instruments being added to the system and no changes to the design, functionality, and application of the devices that make up the system cleared under K222465. From the evidence submitted in this 510(k), the indications for use are similar to already marketed predicates. ## 21 CFR 807.92(a)(5) ### 21 CFR 807.92(a)(6)