Search Results

The Medusa Orthopedics Boa External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects.

The Medusa Orthopedics Boa External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

The Medusa Orthopedics Boa External Fixation System is a ring fixator device used to stabilize and maintain alignment of complicated bone fractures, soft tissue and/or congenital deformity repairs of an extremity. The fixator consists of two rings connected by four (4) struts that are lengthened and shortened independently. It is a modular system and facilitates a multitude of frame configurations to provide a wide variety of patient needs. The independent motion of the struts allows the surgeon to adjust the position of the proximal and distal rings. By utilizing the body's natural ability of osteogenesis to grow new bone tissue, the system guides the orientation and position of the new bone to the desired corrected location in a steady controlled manner.

N/A

Ask a specific question about this device

INTENDED USE

The Response Ortho Smart Fixator - Hexapod System is intended for use in adult patients and pediatric patients greater than 2 through 21 years of age for the treatment of open and closed fractures, arthrodesis and pseudoarthrosis of long bones, limb lengthening, deformity and angular correction, bony or soft tissue defect correction, and malunions. This is accomplished by construction of an external fixator frame and a computer-assisted planning and correction application. Based on surgeon input of examination and radiographic measurements, the software provides a schedule of adjustments for the fixator frame.

INDICATIONS FOR USE

The Smart Fixator - Hexapod System is indicated for adult patients and pediatric patients greater than 2 through 21 years of age for the following:

• Joint contracture resulting in loss of range of motion.
• Fractures and disease which generally may result in joint contractures or loss of range of motion.
• Fractures requiring distraction.
• Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar).
• Correction of bony or soft tissue defects.
• Correction of bony or soft tissue deformities.
• Joint arthrodesis.
• Infected fractures or nonunion.
• Limb lengthening by epiphyseal or metaphyseal distraction.
• Pseudoarthrosis of long bones.

The Response Ortho Medical Smart Fixator - Hexapod System: a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the position to adjust the position of one ring relative to the other. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Fixator - Hexapod System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steadily controlled fashion. In addition to the hardware, the Smart Fixator - Hexapod System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images and the fixator parameters into the software. The software is used preoperatively to plan the reconstruction/correction and identify the frame construction. Post operatively, the surgeon enters the X-ray images and the current frame parameters to establish an adjustment schedule for the patient during the healing process.

N/A

Ask a specific question about this device

MyPAO SA patient-specific guides are devices intended to be used as anatomical guides. The guides are specifically designed based on the CT images of the patient (i.e., pelvis, proximal femur, distal femur). The guides are intended to assist the surgeon in the positioning of the acetabular fragment during periacetabular osteotomies to treat patients who require to undergo periacetabular osteotomy. MyPAO SA guides are intended for single use only.

The MyPAO SA guides are a set of patient specific 3D printed guides produced using patients' CT scans, intended to assist the surgeon in reaching the desired level of correction during periacetabular osteotomies.

The MyPAO SA guides represent a range extension as well as a simplified approach with respect to the already existing MyPAO guides cleared within K220706. The MyPAO SA guides, and their related preoperative and postoperative 3D printed bone models, are single-use surgical instruments provided non-sterile to the end-user.

The MyPAO SA Realignment System is composed of:
• One Preop SA guide used to mark the path of the planned line and to drill holes that facilitate placement and fixation of the Realignment SA Guide during the realignment phase.
• One Realignment SA Guide placed on the acetabular and iliac fragments after osteotomy, allowing for intraoperatively assessing the positioning of the acetabular bone fragment.
• 3D printed bone models of the preoperative and postoperative condition of the patient.

The MyPAO SA guides are available in two configurations, allowing to perform both right and left hip surgeries.

Given their design, the MyPao SA guides require a less invasive surgical access with respect to the predicates MyPao guides (K220706). On the other hand, the new MyPao SA guides are not indicated in case of reverse PAO corrections.

N/A

Ask a specific question about this device

The SternaFuse Ti Fixation System is indicated for use in the stabilization and fixation of fractures of the anterior chest wall or sternum, including sternal fixation following sternotomy, sternal fractures, and sternal reconstructive surgical procedures to promote fusion. The system is intended for use in patients with normal and/or poor bone quality. The device is for prescription use only.

The SternaFuse Ti Fixation System implants are manufactured from titanium alloy (Ti6AL-4V ELI) Per ASTM F136 implant quality titanium plates, and screws intended to stabilize and fixate fractures of the anterior chest wall. The components include various sizes to facilitate customization according to the requirements of the anterior chest wall repair. Self-drilling locking screws come in 3.5mm diameter, and lengths of 10mm, 12mm,14mm,16mm,18mm and 20mm. Multiple plates may be used in one anterior chest wall repair.

All implants are provided non-sterile. The implants should never be reused under any circumstance.

N/A

Ask a specific question about this device

The ToeJack MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.

The ToeJack MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and locking 3.0mm diameter titanium screws that provide fixation for the first metatarsal in the correction of a bunion. Specifically, the plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the proximal shaft with 2 screw fixation and extramedullary medial insertion of the 2 distal screws. Further, the device is provided with a screw targeting insertion guide.

N/A

Ask a specific question about this device

The KLS Martin IPS Forearm System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or will not be crossed by fixation.

The KLS Martin Individual Patient Solutions (IPS) Forearm System is comprised of additively manufactured, patient-specific models, guides and metallic bone plates. The plates will be used in conjunction with previously cleared metallic bone screws and locking pins for internal fixation, alignment, stabilization, reconstruction, and/or corrective osteotomies of the radius and/or ulna. The devices are designed and manufactured to be patient-specific based on the electronic medical image of the patient's anatomy; with input from the physician during virtual planning, prior to finalization, and prior to production of the device. The physician provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an appropriate fit.

Implants are provided non-sterile and are manufactured using additive methods from Ti-6Al-4V. The system also includes the necessary fixation devices and instruments to facilitate placement of the implants.

N/A

Ask a specific question about this device

The Skeletal Dynamics Geminus Volar Distal Radius Plating System is intended for fixation of fractures and osteotomies of the distal radius.

The current Geminus Volar Distal Radius Plating System includes medical grade titanium alloy (Ti 6Al-V4 ELI) bone plates offered in 12 sizes, an ulnar hook plate, Cobalt-Chromium-Molybdenum (CoCrMo) and titanium alloy (Ti 6Al-V4 ELI) bone screws and pegs, and specialized instrumentation for the repair of distal radius and osteotomies. The system also includes the Radial Hook Plate extensions to buttress a volar marginal fragment, and the Buttress Button assembly to capture and hold small dorsal corner fractures.

The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

The Geminus Volar Distal Radius Plating System is comprised of:

N/A

Ask a specific question about this device

The Wristar MultiAx Distal Radius Kit is indicated for:

• Fixation of complex intra- and extra-articular fractures of the distal radius
• osteotomies of the distal radius

The WRISTAR MultiAx Distal Radius Sterile Kit is indicated for both intra-articular and extra-articular fractures of the distal radius (2R3-A2 and 2R3-A3, 2R3-B/C) and for distal radius osteotomies. The system is comprised of various plates and screws which allow it to be customized to a patient's anatomy and fracture pattern. The plate is secured in place via MultiAxial and cortical screws.

The WRISTAR MultiAx Distal Radius Volar Plate is available in various lengths to accommodate patient anatomy and fracture type of the malleolus bone. The plate is provided either with threaded holes or tapered holes. The head of the plate has a shape and contour that provides bone support and a low profile that minimizes the potential for soft tissue irritation.

Screws are available in two designs: cortical and MultiAx.

N/A

Ask a specific question about this device

KLS-Martin Micro Osteosynthesis System (1.5MM): The KLS-Martin Micro Osteosynthesis System (1.5MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.

KLS Martin Centre-Drive Drill-Free Screw: The KLS Martin Centre-Drive Drill-Free Screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced.

KLS Martin Rigid Fixation - Sterile: The KLS Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use:

• The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
• The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
• The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference
• The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
• The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.

Individual Patient Solutions - Ti (IPS-Ti)*: Individual Patient Solutions - Ti (IPS-Ti) is intended to replace bony voids in the mandibular, maxillofacial or craniofacial skeleton.

Individual Patient Solutions - PEEK (IPS-PEEK)*: Individual Patient Solutions - PEEK (IPS-PEEK) is intended to replace bony voids in the cranial and/or craniofacial skeleton.

Individual Patient Solutions - (IPS-PEEK):** The Individual Patient Solutions - (IPS-PEEK) is intended to replace bony voids in the cranial skeleton.

KLS-Martin Micro Osteosynthesis System (1.5mm): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the bones of the skeletal system after a facial fracture or surgery. The bone plate system is composed of bone plates and screws of various shapes and sizes for use in oral-maxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 1.0mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.5mm - 1.8mm.

KLS Martin Centre-Drive Drill-Free Screw: The KLS Martin Centre-Drive Drill-Free Screws are designed to eliminate the need for pre-drilled pilot holes. They are self-tapping with one step insertion. They are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates where are contoured to fit the bony surface and stabilize the bone fragments. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 2.0mm.

KLS Martin Rigid Fixation - Sterile: The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and diameter and stainless steel sonotrode tips that are provided in sterile packaging. The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's previously cleared osteosynthesis products in sterile packaging.

Individual Patient Solutions - Ti (IPS-Ti)*: The Individual Patient Solutions - Ti (IPS-Ti) is a preformed implant manufactured from Titanium material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

Individual Patient Solutions - PEEK (IPS-PEEK)*: The Individual Patient Solutions - PEEK (IPS-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

Individual Patient Solutions - (IPS-PEEK)**: The Individual Patient Solutions - (IPS-PEEK) is a preformed implant manufactured from PEEK material offered to the end-user as a sterile product. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

N/A

Ask a specific question about this device

Surgical Guides and Anatomical Models:
The MedCAD® AccuStride™ System surgical guides and anatomical models are intended to be used as surgical instruments to assist in preoperative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies in the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only. The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., CT).

Fixation Plates:
The MedCAD® AccuStride™ System fixation plates are indicated for use in trauma, general surgery, and reconstructive procedures of the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System fixation plates are intended for single use only. The MedCAD® AccuStride™ System fixation plates should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., CT).

The MedCAD® AccuStride™ System is a collection of two individual pieces of software and associated additive manufacturing equipment intended to provide a variety of outputs to support operations in the foot. The system uses electronic medical images of the patient's anatomy and input from the physician to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system include anatomical models, surgical guides, fixation plates, and patient-specific case reports.

The MedCAD® AccuStride™ System includes patient specific metal bone plating used in conjunction with commercially available metal bone screws for the fixation to bone in trauma, general surgery, and reconstructive procedures of the foot. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (i.e., CT scan), and the intended anatomy to be fixated as determined from input provided by the surgeon. The subject device is not intended to be bent or modified in surgery. Plates are additively manufactured from Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy and are provided clean but non-sterile for end-user sterilization. Plates are fastened using commercially available locking and non-locking bone screws with diameters ranging from 2.0mm to 4.0mm and lengths ranging from 10mm to 60mm. Plates have been pre-validated for use with locking and non-locking screws from the Osteomed Extremilock Foot Plating System (K131445) and the Osteomed Extremilock Ankle Plating System (K133691). When use of an alternate screw to the pre-validated screw offerings is desired, users must consult the Surgical Technique Guide for information.

Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and prior to delivery of the final outputs. The system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.

N/A

Ask a specific question about this device