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Intended Use: The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. Indications for Use: Mini-Frag System The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, non-unions, malunions, replantations, and fusion 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 and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-Frag 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 including, but not limited to, ankle fractures, periarticular fractures, corrective osteotomies, non-unions, intra- and extra-articular and distal tibia fractures with a shaft extension, and malleolar fractures; · 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; - In distal tibia/fibula long bones which include the metaphyseal region of the tibia and fibula in the ankle. The Tyber Medical Ankle Fracture/Fusion System is not for spinal use.

The Tyber Medical Anatomical Plating System consists of this submission, with a brief description of each system below: 1. Tyber Medical Mini-Frag System 2. Tyber Medical Ankle Fracture/Fusion System Mini-Frag System The Tyber Medical Mini-Frag System offers a variety of plating options for the fixation of bone fragments. The system incorporates plates of various lengths, thicknesses, and configurations. The system also incorporates standard (non-locking) and locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized trays are available specific to the Tyber Medical Mini-Frag System. Other ancillary instrumentation is available that is not specific to the Tyber Medical Mini-Frag System. The plates subject to this submission are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type Il surface treatment. The screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing for sizing. The subject devices are offered non-sterile. Ankle Fracture/Fusion System The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system incorporates plates of varying lengths, thicknesses, and configurations. The system also incorporates standard (non-locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized drill guides and trays are available specific to the Tyber Medical Ankle Fracture/Fusion System. Other ancillary instrumentation is not specific to the Tyber Medical Ankle Fracture/Fusion System. The plates subject to this submission are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type Il surface treatment. The screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing for sizing. The subject devices are offered non-sterile.

Intended Use: The intended use of the Tyber Medical Anatomical Plating System is to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Fraq System and Ankle Fracture/ Fusion System with the following indications: Indications for Use: Mini-fraq System The Tyber Medical Mini-Fraq System is indicated for fixation of 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 intended for reduction and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-frag 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, periarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; - In intra- and extra articular fractures, osteotomies, 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 systems presented in this Special 510(k) submission consist of various bone plates, locking screws, washers, and instruments. The Tyber Medical Anatomical Plating System consists of the following categories: 1.Mini-frag System 2.Ankle Fracture/Fusion System A description of each system is provided below: Mini-frag/Small Bone System The Tyber Medical Mini-frag System is designed to address a variety of indications for short bones and sincluding, but not limited to, the hand, wrist, foot and ankle. The System will incorporate both Locking Screws and standard non-locking Screws in 2.0, 2.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.0mm sizes. All locking screws can be placed on-axis with the internal plate threads or up to 15 degrees off axis in any direction. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional bone screw washers 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 instruments are not specific to the system. The Tyber Medical Mini-frag/Small Bone System is offered both sterile and non-sterile. Ankle Fracture/Fusion System The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The System will incorporate both locking Screws and standard non-locking screws in 2.7, 3.0, 3.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.7, 3.5, and 4.0mm sizes. All locking screws can be placed onaxis with the internal plate threads or up to 15 degrees off axis in any direction. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional screw washers are composed of Ti-6AI-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 instruments are not specific to the system. The Tyber Medical Ankle Fracture/Fusion System is offered both sterile and non-sterile.

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 Pin and Wire System is indicated for use in fixation of small bone fragment(s) of hand or foot), bone reconstructions, and as guide pins for inplants or implantation through the skin so that traction may be applied to the skeletal system.

The Tyber Medical Pin and Wire System is designed for hand, foot, and small bone fragment repairs or fusions. Uses include fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants. It is manufactured from stainless steel, and Titanium Alloy. They are available in a variety of lengths, and tips to accommodate different anatomic sizes of patients. The devices are provided non-sterile, single use. Non-sterile devices are intended to be sterilized at the point of use. The pins and wires are made from stainless steel (316L per ASTM F-138) and titanium alloy (Ti-Al-4V ELI per ASTM F136).

Mini-frag System The Tyber Medical Mini-frag System is intended for fixation of fractures, nonunions, replantations, and fusions of short bones and short bone fragments including, but are not limited to, the hand, wrist, foot and ankle. The Tyber Medical Mini-frag System is not for Spinal Use. Foot System The Tyber Medical Foot System is Indicated for Use in fixation of short bones and short bone fragments in the foot (Phalanges and Metatasals), and long bones and long bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures. joint fusions, osteotomies, nonunions, reconstruction of short and long 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, medial malleolar fractures and non-unions of the metaphyseal 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 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-fraq 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, 4). Cloverleaf plates, 6). Straight Fusion Plates, 7). Oblique Fracture Plates, 8), Oblique Fracture Compression Plates, 9), Double Y-Shape Plates, 11. Partial 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 System is offered both sterile and nonsterile 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 short 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). Cuboid 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 Non-locking screws. 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 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-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELL (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 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 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 Malleolus 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, 17). Posteromedial Tibia 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 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.

Cervical System Indications: The Tyber Medical PT Interbody Spacer System is indicated for use as an intervertebral body fusion device in sketally 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 faciliate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, supplemental fixation must be used. Lumbar System Indications: The Tyber Medical PT Interbody Spacer 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). DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may also have had a previous non-fusion spinal surgery at the involved spinal level(s). Additionally, the Tyber Medical PT Interbody System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. Patients should have six weeks of nonoperative 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

This submission is to update language in the Indications for Use, and update language in the package insert in reference to MR testing. There is no change with this submission from the primary predicate. This submission does not change or add any new instruments. The Tyber Medical PT Interbody System, manufactured from PEEK-Optima® LT1, with a plasma-sprayed integrated commercially pure titanium. The system consists 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.