Search Results

The BioDynamik XT3 System is indicated for fracture fixation and bone transport of the tibia in adults.

The XT3 System is composed of the XT3 fixator, Half Pins, and instrumentation, which includes a Spacer, a Drill and Cut Guide, and drivers. The XT3 Fixator and instruments are single-use devices and are supplied non-sterile intended to be steam sterilized prior to use. The Half Pins are provided sterile by gamma irradiation and are for single use only. The XT3 fixator can be adjusted via an incorporated lifting plate to provide fracture fixation or bone transport.

Smith & Nephew's MAVERICK and MAVERICK Mini External Fixation System is intended to be used for temporary stabilization of the long bones, feet, pelvis, and wrist. The indications for the Smith & Nephew MAVERICK Mini External Fixation System are the following: - Open and closed fracture fixation - Bony or soft tissue deformities

The subject of this premarket notification is the MAVERICK Mini External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet, wrist, and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite and titanium bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.

The MAVERICK External Fixation System is intended to be used for temporary stabilization of the long bones, feet, and pelvis. The indications for the Smith & Nephew MAVERICK External Fixation System are the following: - Open and closed fracture fixation - Bony or soft tissue deformities

The subject of this premarket notification is the MAVERICK External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.

The Steinmann Pins are intended to be used in conjunction with a compatible Stryker external supporting frame for stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation. The Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other small bone fractures. • For use as guide wires in hip pinning procedures, • For use in aligning and reducing long bone fractures, • For use in securing temporary stabilization of bone fractures such as olecranon fractures; patella fractures; tibia plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures. • For use with cerclage wire/cable in treating greater trochanter fractures.

The Steinmann Pins and Kirschner Wires are designed for multiple purposes which allow the use in skeletal traction for alignment and reduction of bone fractures, function as fracture fixation devices in certain fractures, preliminary fixation for implants (for example plates) and for evaluation of screw trajectories or guidance for cannulated instruments. The Steinmann Pins and Kirschner Wires are available in different dimensions and provide several design features. The dimensions vary in diameter and length. The design features are the tip geometry which can be a three-sided trocar tip or a two-sided diamond tip on either one end or both ends of the pin. Additionally, some pins are threaded. The pins and wires are made from stainless steel (1.4441).

The Extended HA Half Pins are intended to be used with an external fixation system for fixation of fractures of long bones, joint fusions, and limb lengthening or deformity corrections that involve cutting of the bone and temporary stabilization for the indications listed below. 1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 2. Open and closed fracture fixation 3. Pseudarthrosis of long bones 4. Limb lengthening by distraction 5. Correction of bony or soft tissue deformities 6. Joint arthrodesis 7. Infected fractures 8. Nonunions

Subject of this premarket notification is the Extended HA Half Pins. The proposed devices are design modifications of the Jet-X HA Coated Half Pins to extend the HA coating to the shank of the Half Pins.

The Steinmann pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

The Syntec Non-Sterile Steinmann Pins System is modify from our own device from K983121-Non-Sterile Kirschner Wires and Steinmann Pins product systm. The modify Pins are fabricated from stainless steel (SUS316L) per ASTM F138-13.The design feature for the Non-Sterile Steinmann Pins System is similar to the predicate devices including dimensions, shape, style and sizes.

Orthopedic Fixation Pin is indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants.

The Orthopedic Fixation Pin is straight, partially threaded; and has trocar point on one end. The device is available in various diameters and lengths to accommodate the specific indication. The pins are made from stainless steel in accordance with ASTM F138-13.

Eisertech, LLC Temporary Fixation Pins are indicated for the following: - guide wire for osteosynthesis implants - accessories for external fixation (Steinmann Pin) - application as implant according to the principles of fracture management

The Eisertech, LLC Temporary Fixation Pins are indicated for the fixation of bone fractures, fusion of joints or bone reconstructions, or as guide pins for insertion of other implants. The Temporary Fixation Pins are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either 17-4 stainless steel per ASTM F138 or titanium alloy (Ti-6Al-4V-ELI) per ASTM F136. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.

Devices (K-Wires and Steinmann Pins) are intended to be used as: - · Guide wires for osteosynthesis implants - · Accessories for external fixation (Steinmann Pins) - · Implants according to principles of fracture management

The SMV Scientific K-Wire and Pin consists of K-Wire and Pins in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided nonsterile. All devices are manufactured from medical grade Stainless Steel or Titanium alloys.

The Vilex X-Fix is intended for external fixation with the following indications: 1. Stabilization of Fractures & Osteotomy 2. Rear & Mid-foot Foot Arthrodesis 3. Adult and Pediatric Leg Lengthening 4. Correction of Bone Deformity in Upper & Lower Extremities

This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.