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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 the hand, wrist, foot, and ankle. The minifrag system is also intended for reduction and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use.

The Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System consists of titanium plates (straight and T-plate) and locking /non-lockingscrews (1.3mm) and are offered in a range of configurations to accommodate patient anatomy. The plates and screws are non-sterile.

The TM Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the following indication categories: I. TM Plating System - Complete Articular The TM Plating system is indicated for the treatment of nonunions, osteotomies, and fractures of the femur and tibia. This includes simple, comminuted, lateral wedge, bicondylar combination of lateral wedge and depression, diaphyseal, epiphyseal, extra- and intra-articular fractures, periprosthetic, and fractures with associated shaft fractures. II. TM Plating System - Partial Articular The partial articular (also called buttress or anti-glide) proximal tibia plates are indication and reduction of proximal tibia fragments and treatment of partial articular fractures of the proximal tibia (AO/OTA Fracture Classifications Type B). The partial articular straight plates are indication and reduction of long bone fragments and partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula.

The system presented in this 510(k) submission consists of various bone plates, locking screws, and instruments. The TM Plating System consists of the following indication categories: Tyber Medical Anatomical Plating System 1. Complete Articular (All OA/OTA fracture classification types) 2. Partial Articular (OA/OTA fracture classification type B) A description of each category is provided below: Tm Plating System – Complete Articular The TM System is designed to address a variety of indications for long bones of the tibia and femur. The system is composed of a Straight Plate and a Lateral Proximal Tibia Plate. TM Plating System - Partial Articular The Partial Articular plates of TM Plating System are designed to address specific indications for long bones of the tibia and fibula. These buttress (anti-glide) plates are designed for stabilization of bone fragments, and are intended to treat OA/OTA fracture classification type B fractures only. The system will incorporate variable angle locking and non-locking screws in various lengths and diameters. All plates and screws are composed of Ti-6Al-4V ELI (ASTM F136). A full set of Ancillary Instrumentation is available with the system. The instruments are not specific to the system. The TM Plating System plates are offered nnly. The screws offered in this system have already been cleared in K222465 and are offered in both sterile and non-sterile.

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 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.

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 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.

The Tyber Medical Distal Radius Plating System includes the Tyber Medical Distal Radius, Forearm, and Fragment-Specific plates, which are indicated for fixation for fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand. The Tyber Medical Distal Radius System is not for Spinal Use.

The Tyber Medical Distal Radius Plating System presented in this 510(k) submission consist of various bone plates, screws, and instruments. Distal Radius Plating System The Tyber Medical Distal Radius System provides fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand. The system will incorporate variable angle locking and non-locking screws in various lengths and diameters. All plates and screws are composed of Ti-6Al-4V ELI (ASTM F 136) or Stainless Steel (316L). A full set of Ancillary Instrumentation is available with the system. The instruments are not specific to the system. The Tyber Medical Distal Radius Plating System is offered both sterile and non-sterile.

The Tyber Medical Staple System is indicated for: - Fracture and osteotomy fixation, joint arthrodesis hand and foot. - Fixation of proximal tibial metaphysis osteotomy. - Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. - Fixation of small bone fragments (i.e., small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and in flat bone such as the pelvis and scapula.

The Tyber Medical Staple Fixation System consists of sterile, single use orthopedic implants and instruments. The single use bone fixation compression staples are intended to be permanently implanted. The staples are made out of Nickel Titanium (Nitino) available in two or four legged designs with multiple combinations of bridge width, leg lengths, and cross sections to accommodate various anatomies. The staple implant applies compression across the bone segments when the staple implant legs are released from an insertion system that applies opposing forces to the staple legs to keep them parallel during implantation. The staple is provided preloaded on a disposable inserter. The sterile staple kit contains all the instruments necessary for a single-staple-implantation procedure. These instruments include an inserter with a preloaded staple implant, locating pin, a drill guide for creating appropriately spaced holes and drill bits to create appropriately sized holes in the bone for staple implantation. These components will be provided in a sterilized package to accommodate a range of anatomical sites and are discarded after the procedure is complete, removing the need for any facility reprocessing.