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The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.

The Xpert Knee range consists of plates and screws designed for the fixation of fractures, nonunions and malunions of the proximal tibia in adults. The plates and screws of the Xpert Knee range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use. The instruments of the Xpert Knee range will be provided non sterile for sterilization by health care professionals prior to use. Materials: CP Titanium grade 4 (conform to ASTM F67 and ISO 5832-2) for the plates, and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3) for the screws. Function: The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.

The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy, High Tibial Lateral Closing Osteotomy, High Tibial Anterior Closing Osteotomy, Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting guides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The purpose of this 510(k) notification is to add PSI Guides for High Tibial Lateral and Anterior Closing osteotomies. Material: Polyamide (PA2200).

The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy. Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting quides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The primary purpose of this 510(k) notification is to add PSI Guides for closingwedge and derotation osteotomies.

The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening Wedge Osteotomy and Distal Femoral Lateral Opening Wedge Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices. The subject devices are surgical drilling/cutting quides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or guiding surgical instruments in orthopaedic surgery (High Tibial Medial Opening Wedge Osteotomy and Distal Femoral Lateral Opening Wedge Osteotomy). They are single-use devices provided non sterile for sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of Newclip High Tibial Osteotomy System or the Newclip Activmotion Range devices.

The BOND MMR Antibody Panel is intended to be used for the qualitative identification by light microscopy of human mismatch repair (MMR) proteins MLH1, MSH2, MSH6 and PMS2 in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue sections by immunohistochemical staining. The BOND MMR Antibody Panel includes BOND Ready-to-Use Primary Antibody MLH1 (Mismatch Repair Protein) (ES05), BOND Ready-to-Use Primary Antibody MSH2 (Mismatch Repair Protein) (79H11), BOND Ready-to-Use Primary Antibody MSH6 (Mismatch Repair Protein) (EP49) and BOND Ready-to-Use Primary Antibody PMS2 (Mismatch Repair Protein) (EP51). The BOND MMR Antibody Panel is intended for use on the BOND-III or BOND-MAX fully automated systems with BOND Polymer Refine Detection. The BOND MMR Antibody Panel is indicated for the detection of MMR protein deficiency as an aid in the identification of potential hereditary nonpolyposis colorectal cancer (HNPCC)/Lynch Syndrome in patients diagnosed with CRC. Patients with "MMR Loss" results should receive additional diagnostic testing consistent with clinical practice guidelines for diagnosis of Lynch syndrome. The BOND MMR Antibody Panel is not intended for use in indications other than CRC. This test should not be used for diagnosis of CRC. The clinical interpretation of any staining or its absence when using the BOND MMR Antibody Panel should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. The clinical performance of this device to guide treatment of MMR deficient patients has not been established.

The BOND MMR Antibody Panel [subject device] consists of the following BOND Ready-to-Use (RTU) Primary Antibody (PA) products: - MLH1 (Mismatch Repair Protein) (ES05) (PA0988-U) . - MSH2 (Mismatch Repair Protein) (79H11) (PA0989-U) . - . MSH6 (Mismatch Repair Protein) (EP49) (PA0990-U) - . PMS2 (Mismatch Repair Protein) (EP51) (PA0991-U) The BOND MMR Antibody Panel is intended for use on the BOND-III or BOND-MAX fully automated systems with BOND Polymer Refine Detection (DS9800). The BOND MMR Antibody Panel is indicated for the detection of mismatch repair protein deficiency as an aid in the identification of potential Hereditary Non-Polyposis Colorectal Cancer (HPNCC)/Lynch Syndrome in patients diagnosed with CRC. MLH1 (Mismatch Repair Protein) (ES05) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7 mL. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). MSH2 (Mismatch Repair Protein) (79H11) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). MSH6 (Mismatch Repair Protein) (EP49) is a rabbit anti-human monoclonal antibody produced as an affinity-purified tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). PMS2 (Mismatch Repair Protein) (EP51) is a rabbit anti-human monoclonal antibody produced as an affinity purified tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). Instrument and Software: The BOND-MAX and BOND-III instruments are fully automated slide stainers that perform automated deparaffinization (dewaxing), antigen retrieval, immunohistochemistry (IHC) staining/in situ hybridization (ISH) staining, and counterstaining. The major components of the BOND staining platforms are the processing module, computer (BOND controller), handheld ID scanner, and slide label printer. The BOND staining platforms are composed of a number of discrete software components including the BOND application software, BOND instrument/processing module software, BOND service software, and Laboratory interface system - integration package (LIS-IP).

The implants of the Footmotion Plating System are intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.

The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The implants of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. The instruments of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use.

The implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.

The Activmotion S DTO range consists of plates and screws designed for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula. The Activmotion S DTO range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use. Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3).

The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

The Xpert Wrist range consists of plates and screws, designed for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults. The implants of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. The instruments of the Xpert Wrist range will be provided non sterile for sterilization by health care professionals prior to use. Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.

The Activ Fuse range consists of plates and screws designed for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus. The system includes a modular plate design for a lateral calcaneal extension. The Activ Fuse range will be provided non-sterile for sterilization by health care professionals prior to use, or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Activ Fuse range are intended for bone reconstruction of the ankle joint in adults including fractures fixation and arthrodeses of the ankle, distal tibia, talus and calcaneus.