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In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat- Cut QUANTUM® talar implants. PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the positioning of the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones. TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.

The previously cleared single use QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of: • QUANTUM® patient specific instrumentation (PSI) and reusable instruments: - QUANTUM® patient specific tibial and talar guides; - QUANTUM® reusable instruments; - QUANTUM® patient specific tibial and talar bone models • ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software (specific modification implemented in this submission). The QUANTUM® PSI Guides are patient-specific devices adapted to the patient bones anatomy and the preoperative surgical plan validated by the surgeon. QUANTUM® PSI guides and bone models are designed using the dedicated ORTHO-PLANIFY TAR planning software. The QUANTUM® system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The ORTHO-PLANIFY TAR planning software involved in this submission was previously cleared under K221432. The scope of this submission is an addition of a manufacturer for the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883.

In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants. PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones. TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.

The previously cleared single use QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of: • QUANTUM® patient specific instrumentation (PSI) and reusable instruments: - QUANTUM® patient specific tibial and talar guides; - QUANTUM® reusable instruments; - QUANTUM® patient specific tibial and talar bone models (not medical devices); • ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software. The QUANTUM® PSI system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. QUANTUM® PSI guides are single use instruments designed using the dedicated ORTHO-PLANIFY TAR planning software, in correlation with a pre-operative surgical plan validated by the surgeon. They fit the anatomy of the specific patient's distal tibia and proximal talus. The scope of this submission is an addition of a manufacturer, slight update to dimensions and raw material for the cut guides related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883.

In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants. PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the positioning of the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones. TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.

The QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of: • QUANTUM® patient specific instrumentation (PSI) and reusable instruments: - QUANTUM® patient specific tibial and talar guides; - QUANTUM® reusable instruments; - QUANTUM® patient specific tibial and talar bone models; • ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software. The QUANTUM® PSI system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. QUANTUM® PSI guides are single use instruments designed using the dedicated ORTHO-PLANIFY TAR planning software, in correlation with a pre-operative surgical plan validated by the surgeon. They fit the anatomy of the specific patient's distal tibia and proximal talus.

The Quantum® total ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Note: In the United States, the ankle prosthesis is intended for cement use only.

The QUANTUM® Total Ankle Prosthesis is a fixed-bearing total ankle replacement device. The prosthesis is composed of a tibial implant, a tibial inlay, and a talar implant. Both the tibial implant and talar implant are secured to patient anatomy via bone cement; the intermediate inlay is rigidly fixed to the tibial implant intra-operatively. When all three components are implanted, the intermediate inlay acts as a bearing along the talar implant, enabling movements at the replaced joint. Components are available in a variety of sizes and design configurations to accommodate the various anatomical needs of a patient's ankle joint, and intended for both primary and revision applications. QUANTUM® Total Ankle Prosthesis is accompanied by a complete instrumentation set including trial and drill/cutting guide to assist surgeons in implantation of the device.

The TRIWAY® TTC Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: - Post-traumatic and degenerative arthritis involving both ankle and subtalar joints - Rheumatoid arthritis with severe deformity - Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body - Revision of failed total ankle arthroplasty with subtalar intrusion - Talar deficiency conditions, including avascular necrosis (requiring a tibiocalcaneal arthrodesis) - Neuroarthropathy or neuromuscular deformity or other neuromuscular disease with severe deformity of the ankle, including Charcot foot - Severe pilon fractures with trauma to the subtalar joint - Malunited tibial pilon fractures The addition of an IBS™ 6.5mm compression screw through the subtalar joint and through the nail is required.

The TRIWAY® Tibiotalocalcaneal (TTC) Arthrodesis System is composed of an angulated nail available in several sizes and different screws for bony fixation. Rigid fixation is achieved by screws. An instrument set is available for the bone preparation, screw sizing and insertion of the TRIWAY® TTC Arthrodesis System. A specific targeting device is available for the positioning and the insertion of the different cotter screws and the I.B.S® 6.5mm compression screw, which is inserted in an oblique way to provide additional compression throughout the nail, between the calcaneus and the talus. Sizes: The TRIWAY® Arthrodesis Nail is available in several sizes, with left and right versions (diameter 10, 11, 12mm, lengths from 160mm to 250mm). Cotter screws are available in 5.0mm diameter, with length ranging from 25 to 110mm by 5mm increment. Material: The TRIWAY® TTC Arthrodesis System implants (nail and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136. Single use: The TRIWAY® TTC Arthrodesis System is designed for single use only. Sterilization: The TRIWAY® TTC Arthrodesis System is supplied sterile, using gamma irradiation.

The DIP implants are indicated for distal interphalangeal joint fusion of the long fingers. Treatment may include complementary immobilization of the finger (e.g. splint) if considered preferable by the surgeon.

The Distal InterPhalangeal (DIP) Arthrodesis System, is composed of intramedullary implant, designed to act as a bone fastener for distal interphalangeal arthrodesis of the long fingers. The implant is composed of 2 parts implanted in the proximal and distal phalanx and locked together in a rigid arthrodesis system. Sizes: The DIP Arthrodesis System is composed of implants available in different lengths and angles. The proximal implant is available in two sizes. The distal implant is available in 2 sizes combined with two angles of plantar flexion: 0 degree or 15 degrees to accommodate the size variation of the phalanges across the patient population and interphalangeal angles. Material: The DIP Arthrodesis System is manufactured from PEEK-OPTIMA® (PolyEtherEtherKetone) polymer from Invibio® as per ASTM F2026, a radiolucent material. Single use: The DIP Arthrodesis System is designed for single use only. Sterilization: The DIP Arthrodesis System is supplied sterile, using gamma irradiation.

The PIT Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. - Flat foot treatment in children and adolescents - Congenital flat foot - Non successful long term orthopaedic treatment (shoes, insoles ... ) - Tarsal coalitions - Painfully flat foot - Supple deformity in posterior tibial tendon dysfunction - Paralytic flat foot - Subtalar instability

The PIT'Stop® implant is a cannulated implant composed of two symmetrical and flattened sides, and small blades. The PIT'Stop® implant is designed to adequately maintain the filling of the sinus tarsi, and is made of PEEK, a material recognized for its mechanical and radiolucent properties. The PIT'Stop® implant is introduced into the axis of sinus tarsi, and its fixation is performed by anti-return flanges. The PIT'Stop implant should be removed: at the end of the growth when used in pediatric patients or by 12 months when used in adult patients or if pain occurs earlier Sizes: The PIT'Stop® implant is designed in 7 sizes, from 10mm to 17mm. Material: The PIT'Stop® implant is made of PEEK according to standard ASTM F2026 and include markers made of tantalum according to ASTM F560. Single use: The PIT'Stop® implant is designed for single use only. Sterilization: The PIT'Stop® implant is supplied sterile, using gamma irradiation.

The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus. The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.

The Ankle Fusion Plating System is composed of an anatomically contoured plate, with a distal part adapted to the talar neck, and a proximal part adapted to the distal tibial epiphysis and diaphysis. Rigid fixation is achieved by screws. The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V. A dedicated instrument set is available for the bone preparation, screw sizing and insertion of the Ankle Arthrodesis Plating System. A specific targeting device is available for the insertion of the additional I.B.S® 6.5mm screw. Sizes: The Ankle Fusion Plate is available in one size, with left and right versions. Fixation screws are available in 3.5 or 4.5mm diameter, with length ranging from 10 to 100mm. Material: The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136. Single use: The Ankle Fusion Plating System is designed for single use only. Sterilization: The Ankle Fusion Plating System is supplied sterile, using gamma irradiation. Place of use: The Ankle Fusion Plating System is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.

The I.B.S.TM compression and neutralization osteosynthesis screws are intended for: - The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs - Osteosynthesis requiring a mono or bicortical compression The size of the chosen screw should be adapted to the specific indications.

The modified I.B.STM osteosynthesis screws are a range extension of the existing screw line cleared in K131920 I.B.STM osteosynthesis screw. The modification made on the I.B.S.TM osteosynthesis screw are: I.B.S.TM Osteosynthesis Compression Screw, diameter 6.5mm: - Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references; - Modification of the distal thread to a long distal thread for screws, with total length comprised between 60mm and 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Neutralization Screw, diameter 6.5mm: - Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Compression and Neutralization screw, diameter 2.5mm: - Range extension of the total screw length, with addition of length 30mm, and creation of dedicated references.

The I.B.S.TM 2.0 Osteosynthesis screws are intended for: - The fixation of arthrodeses, osteotomies or fractures of the upper and lower limbs - Osteosynthesis requiring mono or bicortical compression The size of the chosen screw should be adapted to the specific indications.

The I.B.S.TM 2.0 Osteosynthesis screw is a line extension of the existing compression screw line cleared in K131920 I.B.S.TM Osteosynthesis screw. The I.B.S.TM 2.0 Osteosynthesis screws are cannulated screws available in a compression design. The cannulation of the screws provides a helpful feature during surgery, as a wire is used to guide insertion of the screw. The compression design has a non-threaded shaft, allowing optimal compression between the two bone fragments, which may enhance bone osteosynthesis. The I.B.S.TM 2.0 Osteosynthesis screws are self-drilling and self-tapping screws, which enables introduction of the screw without any preparation of the hole (using a drill and /or a tap) in most cases. Sizes: The I.B.S.TM 2.0 Osteosynthesis screws are available in 2.0mm diameter, in length ranging from 10mm to 30mm. Material: The I.B.S.TM 2.0 Osteosynthesis screws are manufactured from titanium alloy Ti6Al4V as per ISO 5832-3 and ASTM F136. They do not have any coatings. Single use: The I.B.S.TM 2.0 Osteosynthesis screws are designed for single use only. Sterilization: The I.B.S.TM 2.0 Osteosynthesis screws are supplied sterile, using gamma irradiation. Place of use: The I.B.S.TM 2.0 Osteosynthesis screws are indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.