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Pangea Platform: The Pangea Platform is indicated for the internal fixation and stabilization of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including: - Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - Non-unions, malunions, and deformities - Periprosthetic fractures The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants. Pangea Femur Plating System: The Pangea Femur Plating System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including: - Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - Non-unions, malunions, and deformities - Periprosthetic fractures Pangea Tibia Plating System: The Pangea Tibia Plating System is indicated for the internal fixation and stabilization of tibia bone fractures and osteotomies in normal and osteopenic bone, including: - Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - Non-unions, malunions, and deformities - Periprosthetic fractures Pangea Humerus Plating System: The Pangea Humerus Plating System is indicated for the internal fixation and stabilization of humerus bone fractures and osteotomies in normal and osteopenic bone, including: - Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - Non-unions, malunions, and deformities - Periprosthetic fractures

This traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the Pangea Platform, Pangea Femur Plating System, Pangea Humerus Plating System, and Pangea Tibia Plating System. This line extension consists of Class II instruments intended to assist in targeting.

The VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist, including osteopenic bone.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the VariAx 2 Distal Radius System. This line extension consists of anatomically pre-contoured plates for the treatment of simple and complex fractures of the distal radius, together with specialized instrumentation. All new plates are manufactured from CP Ti Grade 2 (Type II anodization) and are available in different sizes and left/right versions. The plates will be provided both non-sterile and sterile-packaged. They will use the well-established SmartLock technology to allow variable angle screw locking. The plates can be used with non-locking and locking VariAx 2 T8 screws. The VariAx 2 T8 screws have been previously cleared under K191412.

The Hoffmann LRF System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults. The Stryker Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: - Open and Closed Fractures - Post-traumatic joint contracture which has resulted in loss of range of motion - . Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction - Pseudoarthrosis or non-union of long bones - Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction • - . Correction of bony or soft tissue deformity - . Correction of segmental bony or soft tissue defects - . Joint arthrodesis - . Management of comminuted intra-articular fractures of the distal radius - . Bone transport The Hoffmann LRF System is indicated in adults for: - Osteotomy - . Revision procedure where other treatments or devices have been unsuccessful - . Bone reconstruction procedures - . Fusions and replantations of the foot - Charcot foot reconstruction - . Lisfranc dislocations

The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient. The system components are manufactured from stainless steel, aluminum, PEEK, and carbon fiber. Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System, Hoffmann II External Fixation System 90° Post, Hoffmann II Miami Post, Hoffmann II Carbon Connecting Rods, Hoffmann II MRI External Fixation System, and Hoffmann II Compact MRI External Fixation System. Use of these components does not confer MRI compatibility to the Hoffmann LRF System.

The Pangea Utility Plating System is indicated for the internal fixation of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including: - · Diaphyseal, metaphyseal, extra- and intra-articular fractures - · Non-unions, malunions, and deformities - · Periprosthetic fractures The Pangea Utility Plating System is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants. The Pangea Platform is indicated for the internal fixation of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including: - · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - · Non-unions, malunions, and deformities - · Periprosthetic fractures The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis and metaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Pangea Utility Plating System and the Pangea Platform. This submission encompasses multiple systems (Pangea Utility Plating System and Pangea Platform) that have similar intended use and/or will be used together during the surgical procedure. The Pangea Utility Plating System consists of mini-, small-, and large-fragment plates manufactured from Ti6Al4V-ELI per ASTM F136. The plates range in length from 26 mm to 486 mm. The Pangea Platform consists of screws and cable plugs. The screws are offered as locking or non-locking variants. The locking screws are manufactured from CoCr and are available as Ø2.7 mm (L8 mm – 80 mm), Ø3.5 mm (L10 mm – 120mm), Ø4.0 mm (L14 mm – 95 mm), Ø5.0 mm (flat tip) (L10 mm – 20 mm), and Ø5.0 mm (L14 mm – 120 mm). The non-locking screw is manufactured from Titanium alloy (Ti6Al4V-ELI per ASTM F136) and is available in Ø2.7 mm (L6 mm – 80 mm). The cable plugs are made of Titanium alloy (Ti6Al4V-ELI per ASTM F136), and the T15 and T20 cable plugs are available for the 3.5mm locking mechanism. The Cancellous screws are available as Ø4.0 mm fully and partially threaded (L10-100 mm) and Ø6 mm 16mm thread (L30 -150 mm), Ø6 mm 32mm thread (L45 -150 mm) and fully threaded (L20-150 mm).

Pangea Femur Plating System: The Pangea Femur Plating System is indicated for the internal fixation of femur bone fractures and osteotomies in normal and osteopenic bone, including: - · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - · Non-unions, malunions and deformities - · Periprosthetic fractures Pangea Fibula Plating System: The Pangea Fibula Plating System is indicated for the internal fixation of fibula bone fractures and osteotomies in normal and osteopenic bone, including: - · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - · Non-unions, malunions, and deformities - · Periprosthetic fractures Pangea Tibia Plating System: The Pangea Tibia Plating System is indicated for the internal fixation of tibia bone fractures and osteotomies in normal and osteopenic bone, including: - · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - · Non-unions, malunions, and deformities - · Periprosthetic fractures Pangea Humerus Plating System: The Pangea Humerus Plating System is indicated for the internal fixation of humerus bone fractures and osteotomies in normal and osteopenic bone, including: - · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures · Non-unions, malunions, and deformities - · Periprosthetic fractures

This traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, and Pangea Humerus Plating System. This submission encompasses multiple systems that have similar intended use. All plates are manufactured from Ti6Al4V ELI (ASTM F136), are anatomically pre-contoured. and are available in different sizes and left/right versions. The plates are provided sterile or non-sterile and range in length from 68 mm to 441 mm. The plates allow for the use of locking and non-locking screws and are used with cable plugs and washers.

The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The RC Lag Screw is also indicated for rotationally unstable fractures.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market new devices into the Gamma4 System, add new indications for use for the RC Lag Screws and update the current surgical technique to include an optional section to use bone void fillers. The Gamma4 System was previously cleared in K222309, is a hip fracture nailing system and includes sterile implants (Trochanteric and Long Nails in various diameters and sizes, Lag Screws, and End Caps) as well as non-sterile instruments (targeting devices). The subject devices (Intermediate Nails and RC Lag Screw) are also sterile implants in various diameters and sizes as well as a non-sterile Intermediate Targeting Sleeve. All nails and screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136 and the targeting device is manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.

The PeriPRO™ Femur Plating System is indicated for internal fixation of femur fractures and osteotomies in normal and osteopenic bone. This includes: · Non-unions, malunions and deformities · Fracture in the presence of intramedullary implants, including periprosthetic fractures The Variable Angle Fixation System is indicated for the internal fixation of fractures and osteotomies of the femur in normal and osteopenic bone, including: - · Non-unions, malunions and deformities - · Periprosthetic fractures AxSOS 3 Ti is intended for long bone fracture fixation. Indications include: · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - Non-unions and malunions - · Normal and osteopenic bone - · Osteotomies - · Periprosthetic fractures of the femur and proximal tibia. - The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: - · Periprosthetic fractures - · Diaphyseal and metaphyseal areas of long bones in pediatric patients. The 4 mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis. Screws can also be used for arthrodesis. The Stryker Plating System, Small Frag Set is indicated for fractures of the metaphysis of the following: - · One third tubular plate: fibula, metatarsals, metacarpals - Fibular plate: fibula - · Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle - · Oblique T-plate: distal radius - · T-plate: distal radius, calcaneus, lateral clavicle - Cloverleaf plate: proximal humerus, distal tibia - · Calcaneal plate: calcaneus · Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. The Basic Fragment Set is intended for use in long bone fracture fixation plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the PeriPRO Femur and Variable Angle Fixation System and align labeling across the AxSOS 3 Ti and SPS System. This submission encompasses multiple systems (PeriPRO Femur, Variable Angle Fixation, AxSOS 3Ti and SPS Systems) that have similar intended use and/or will be used together during the surgical procedure. The PeriPRO™ Femur System consists of proximal, interprosthetic and distal femur plates. All devices in the system are provided sterile and non-sterile. The proximal femur plates range from 257 up to 371 mm in length. The interprosthetic femur plate ranges from 320 up to 420 mm in length. The distal femur plates range from 173 up to 396 mm in length. All plates are made of titanium alloy (Ti6AL4VELI) according to ASTM 136. The Variable Angle Fixation System consists of screws and cable plugs. All devices in the system are provided sterile and non-sterile. Screws are offered as non-locking or locking variants. The locking screws are available as Ø4 (L22-95 mm), Ø5 mm (L22-120 mm) and Ø5 mm flat tip (L10-20 mm) are made of CoCr alloy. The Cable plugs are available in a 5 mm and are made of titanium alloy. The PeriPRO™ Femur System and Variable Angle Fixation contains Class II instruments as targeters, frame fixators, handles, Those devices are part of the targeting system and as such class II instruments. They are manufactured of either PEI/Carbon or stainless steel. AxSOS 3 Ti System is an internal fixation system composed of sterile and non-sterile plates, screws, and complementary implantable devices, along with associated instruments. The plates are available in a variety of anatomical orientations and lengths, the screws in a variety of diameters and lengths. Implants of this system are available in titanium alloy, with Type II anodization. The Stryker Plating System (SPS System) contains the Basic Fragment Set and the Small Fragment Set. Both sets contain plates, screws, and washers available in titanium alloy (Ti-6A14V) per ASTM F136 as well as stainless steel (316L) in sterile and non-sterile forms. SPS plates come with holes that can accommodate non-locking screws and include holes for suture or Kwires. The screws are provided in 2 types (cortical and cancellous) and are available in several different lengths and diameters.

The PRO Plating System is indicated for: · Fractures, non-unions, deformities and malunions of the pelvic ring and acetabulum • Sacroiliac joint dislocations The Stryker Trauma Pelvic Set (Matta) is indicated for: • Fractures of the acetabulum, sacrum, illium, and entire pelvic ring; • Revision surgery of pseudarthrosis, non-unions and mal-unions; • Osteonomies; • Arthrodeses; • Sacroilic joint dislocations; • Symphysis pubis disruptions

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the PRO Plating System, to align indication of the existing PRO Pelvis System and the new devices and add MRI labeling to the existing PRO Pelvis System and the Trauma Pelvic Set System (Matta). This submission encompasses multiple systems (PRO Pelvis System and Trauma Pelvic Set System (Matta)) that have similar intended use and/or will be used together during the surgical procedure. The PRO Plating System (Pelvis II Implant System) is an internal fixation device that consists of different types of plates used with compatible screws to fit different types of fractures in the pelvis. All devices in the system are provided sterile and non-sterile. The Stryker Trauma Pelvic Set System (Matta) consists of plate, screw, and washer components of various sizes. All are manufactured from stainless steel (ASTM F-138/139). All devices in the system are provided sterile and non-sterile.

The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market two (2) new accessory devices into the Gamma4 System: Plus Targeting Arm and Plus Nail Holding Screw. The Gamma4 System was previously cleared under K213328, is a hip fracture nailing system and includes sterile implants (Trochanteric and Long Nails in various diameters and sizes, Lag Screws, and End Caps) as well as non-sterile instruments (targeting devices). The nails, lag screws and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The Gamma4 System has two (2) types of targeting devices: (1) Proximal Targeting Arm (consisting of Targeting Sleeve and Nail Holding Screw) previously cleared in K213328 and (2) the subject devices, Plus Targeting Arm (consisting of the Plus Nail holding Screw and Targeting Sleeve, previously cleared in K213328). The previously cleared Proximal Targeting Arm has less of an extension out from the axis of the nail, whereas the subject device is more rounded and extends out further to ensure sufficient tissue clearance. Both targeting devices are manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.

Stryker VariAx 2 MIS Calcaneus is indicated for fractures of the calcaneus.

This Traditional 510(k) submission is submitted to the U.S. FDA to provide authorization to market the VariAx 2 MIS Calcaneus plates. The goal of the Subject Device VariAx 2 MIS Calcaneus is to offer a comprehensive range of calcaneal implants and instruments in one system utilizing the VariAx 2 platform technology and SOMA database for the design of the plates. The Subject Device VariAx 2 MIS Calcaneus has an equivalent Intended Use and Indications for Use as the Predicate Device and shares the same principle of operation. Stryker VariAx 2 MIS Calcaneus is a non-active implant(s) intended to provide temporary stabilization for bones or bone fragments.