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The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing and is composed of the following bone plate categories: Mini-frag/Small Bone System The Tyber Medical Mini-Frag/Small Bone System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments including, but are not limited to, the hand, wrist, foot and ankle. The Tyber Medical Mini-frag/Small Bone System is not for Spinal Use. Foot System The Tyber Medical Foot System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals), and medium/ large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, osteotomies, nonunions, malunions, reconstruction of small, medium and large bones, revision surgeries and replantations 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 intended for osteotomies and non-unions, fixation of fractures 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 The Tyber Medical Ankle Fracture/Fusion System is Indicated for Use in: 1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; 2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus; 3). 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/Small Bone System 2. Foot System 3. Long Bone Fracture System 4. Ankle Fracture/Fusion System Mini-frag/Small Bone System: Offers a variety of plates for fixation of bone fragments, including standard and locking compression plates and screws of varying lengths, thicknesses, and configurations. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary instrumentation is available. Offered sterile and non-sterile. Foot System: Consists of a variety of plates with shapes and sizes designed for internal fixation of small bone fragments of the implants are designed to provide highly anatomic and versatile options for an array of fusions and stabilizations of small bones in the feet. Plates are available in various lengths, with straight, right and left configurations and numerous plate types. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile. Long Bone Fracture System: Consists of a straight low contact locking plate and a 1/3 locking tubular plate. Incorporates both Cortical locking and standard Cortical Non-locking screws. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile. Ankle Fracture/Fusion System: Designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. Composed of various locking plate types. Incorporates both Cortical Locking Screws and standard Cortical Non-locking Screws in various lengths. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.

The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories: I. Forefoot System: The Tyber Medical Forefoot Plating System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Tyber Medical Forefoot System is not for Spinal Use. II. Mid & Hindfoot System: The Tyber Medical Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/ large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient. The Tyber Medical Mid & Hindfoot System is not for Spinal Use. III. Ankle Fracture System: The Tyber Medical Ankle Fracture System is Indicated for Use in: I). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; 2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula; 3). In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle. The Tyber Medical Ankle Fracture System is not for Spinal Use.

The Tyber Medical Anatomical Plating System consists of the following categories: 1. Forefoot System 2. Mid & Hindfoot System 3. Ankle Fracture System A brief and concise description of each system is as follows: Forefoot System The Tyber Medical Forefoot System is designed to address a variety of indications in forefoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture Plates, 2). T-Shaped Fracture Plates, 3). Y-Shape Fracture Plates, 4). L-Shaped Fracture Plates, 5). Cloverleaf Fracture Plates, 6). TMT 1 Medial Fusion Plates, 7). Open Wedge Fusion Plates, 8). MTP Fusion Plates, 9). MTP Fusion Revision Plates, and 10). Dorsal TMT 1 Step Fusion Plates, - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.0mm, 2.5mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing. A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Forefoot System is offered both sterile and non-sterile for single-use. Mid and Hindfoot System The Tyber Medical Mid & Hindfoot System is designed to address a variety of indications in midfoot & hindfoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture/Fusion Plates, 2). T-Shaped Fracture/Fusion Plates, 3). L-Shaped Fracture/Fusion Plates, 4). Cloverleaf Fracture/Fusion Plates, 5). X-Shaped Fracture/Fusion Plates, 6). Retangular Fracture/Fusion Plates, 7). Cotton Osteotomy Plates, 8). Dwyer Step Plates, 9). Evans Osteotomy Plates, 10.) Plantar TMT Plates, 11). Distal Medial & 3 - 4 Column Plates and 11). ORIF & Standard Calcaneal Plates - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing. A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Mid and Hindfoot System is offered both sterile and non- sterile for single-use. Ankle Fracture System The Tyber Medical Ankle Fracture System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system is composed of many locking plate types which include: 1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateral Distal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight Low Contact Plates, and 6). Straight 1/3 Tubular Plates – in various plate shapes, lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.8mm, 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of either Medical Grade CP Titanium (to ASTM F67) or 6-4 Alloyed Titanium (to ASTM F136) materials with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing. A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Ankle Fracture System is offered both sterile and non- sterile for single-use.

The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. The purpose of this submission is to add MR Conditional information to the device labeling for K153575. The intended use and technological characteristics of the device remain unchanged.

The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. The purpose of this submission is to add MR Conditional information to the device labeling for K133842. The intended use and technological characteristics of the device remain unchanged.

Cervical System Indications: The Tyber Medical PT Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. Tyber Medical PT Cervical Interbody spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation.

This submission is to add additional ACIF configurations to the Tyber Medical PT Interbody System and corresponding trials. Additionally, the Indications for Use are being revised. The new configurations will be manufactured from PEEK – Optima® and plasma sprayed with commercially pure titanium coating, identical to the existing devices in the system. The new ACIF configurations have superior and inferior surfaces that are inclined at larger angles than the existing configurations. In addition, a new extra-large configuration for these sizes will be included. Other geometries, such as the open lumen area and teeth geometry on the superior and inferior surfaces remain identical to the devices within the Tyber Medical PT Interbody System. The trials will be manufactured from stainless steel and will incorporate trial geometries that match the corresponding implant.

Lumbar System Indications The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine. Cervical System Indications The Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.

This submission is to add additional shape configurations, with an optional optimized coating process, to the previously cleared interbody system. This submission does not include any new instruments. However, part of the changes to implants, were made to interface with instruments that were cleared with previous submissions. The Tyber Medical PT Interbody System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights, and lordotic configurations with an open architecture to accept packing of bone graft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in PEEK with a plasma-sprayed commercially pure titanium coating.

PEEK System Indications The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as: Cotton and Evans Wedges - · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - · Opening wedge of Medial Cuneiform of Cotton osteotomies - · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges - · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cunciform arthrodesis (TMT os Lapidus) The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine TyPEEK System Indications The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as: Cotton and Evans Wedges - · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - · Opening wedge of Medial Cuneiform of Cotton osteotomies - · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges - · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT of Lapidus) The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

This submission is to add additional footprints to the system. The Tyber Medical Wedge System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights and indication configurations with an open architecture to accept packing of bone graft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.

The Tyber Medical BioTy® Nanotopography Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The screw is intended for single use only.

A trauma screw with BioTy® Nanotopography Surface Treatment is designed to apply compression and fixation between two adjacent segments of cortical and/or cancellous bone.

The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. This submission adds a headed screw and snap off option as well as an optional washer to the previously cleared headless trauma screw with and without previously cleared modified surface treatment. The screws will be provided sterile and non-sterile in both solid and cannulated form, made of from titanium (with and without Modified Surface treatment) and

The Tyber Medical MST Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone with modified surface treatment (MST). The screws will be provided sterile in both solid and cannulated form, made of from titanium.