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The indications for the Trinity™ EVO Acetabular Shell as a total hip arthroplasty include: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - Correction of functional deformity. - Developmental dysplasia of the hip (DDH)/Congenital dislocation of the hip (CDH) The Trinity™ EVO acetabular shell is also indicated for use in revisions of a previously failed total hip arthroplasty. The Trinity™ EVO Acetabular Shell is indicated for cementless use only.

The Trinity™ EVO acetabular shell forms part of a modular acetabular system. The Trinity™ EVO acetabular shell is a hemispherical press fit titanium alloy shell for use with cobalt chrome alloy (Trinity™ Dual Mobility only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip arthroplasty (THA) procedures using Corin metal stems with a 12/14 taper connection. The Trinity™ EVO acetabular shell has a porous structure manufactured from titanium alloy powder, produced via additive manufacturing using Laser Powder Bed Fusion (LPBF), and is available with or without an additional layer of electrochemically deposited calcium phosphate. The Trinity™ EVO acetabular shell is provided in sizes permitting the use of titanium bone screws to provide additional fixation, if required. The Trinity™ EVO acetabular shell is also available without screw holes. A titanium occluder is provided to occlude the apical introducer hole. The Trinity™ EVO acetabular shell is intended for use in primary and revision THA in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation when there is evidence of sufficient sound bone to seat and support the components.

ApolloHipX is indicated for use in assisting in Total Hip Replacement in which the use of radiological imaging may be appropriate.

ApolloHipX is a non-invasive intra-operative, image processing software intended to precisely measure the position of total hip replacement (THR) components. The software operates as a near-real time assistive device for THR, measuring component alignment, to assist in precise placement of THR components. The software is intended to be installed on certified hardware (Apollo Station) located outside the patient field. This is accomplished by: • Transfer of intra-operative 2D imaging of the patient from a capture source e.g. an X-ray machine • Registration of the 3D pre-operative patient data to the 2D intra-operative patient imaging • Calculation and display of the component alignment (for final implants as well as intra-operative instruments e.g., broaches and trials) which can be compared to pre-operative target positions. ApolloHipX is intended to precisely measure the position of THR components by measuring implant positions relative to bone structures identifiable from radiological images and providing information on component alignment. Clinical judgment and experience of an orthopaedic surgeon are required to properly interpret the results from the software. The software is not for primary image interpretation.The Apollo Station is the physical structure used to host the power supply and contains two user interfaces (monitor and tablet) from which the user can interact with the software applications. It also houses non-surgical Software that manages the user authentication, system access, data transfer of surgical inputs and communication to Corin's cloudhosted ecosystem. The Apollo Station connects to the imaging device intra-operatively to receive the 2D radiological images.

The indications for the Corin Icona Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemiarthroplasty, include: - · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - · Correction of functional deformity - · Treatment of non-union and femoral neck fractures - Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH) The Corin Icona Hip Stem is indicated for cementless use only.

The Corin Icona Hip Stem is a tapered stem design manufactured from Titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2, ASTM F1580) and an additional layer of electrochemically deposited calcium phosphate (ASTM F1609) applied. The Icona Hip Stem is intended for use in hemiarthroplasty and total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components. The design is a fully-coated titanium femoral hip stem featuring a polished neck with 12/14 tapered male trunnion for assembly with Corin modular femoral head components. Additionally, the Icona stem features a trapezoidal, tripled tapered body, providing for rotational and axial stability. The Icona Hip Stem is a collared stem available in two different offsets (Standard and Lateralised) and twelve (12) different sizes, totaling 24 options. The Icona Hip Stem is compatible with the following acetabular systems: · Traditional – Trinity (K093472, K110087, K111481, K122305, K130128, K130343, K131647) and Trinity PLUS (K17255) · Dual mobility - Trinity Dual Mobility (K170359) and MobiliT (K191831) · Bipolar - Bipolar-i (K183114)

The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is sufficient sound bone to seat and support the components. The General total knee arthroplasty indications include: · Painful, disabling joint disease of the resulting from: degenerative arthritis, theumatoid arthritis or post-traumatic arthritis · Post-traumatic loss of knee joint configuration and function - · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function - · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate - · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques - · The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface with - increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament The Unity Total Knee System is intended for cemented use, single use only.

The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, a UHMWPE (Ultra-High-Molecular-Weight-Polyethylene) or ECiMa (Vitamin E enriched advanced polyethylene) tibial tray with a titanium alloy keel extension and all-polyethylene (UHMWPE) patellar component for use in primary and revision total knee arthroplasty. The Unity Total Knee System femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilised (PS). - The CR femoral component is intended for use in conjunction with the CR tibial insert or Medial Constrained (MC) tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Condylar Stabilised (CS) tibial insert or MC tibial insert where the PCL is present but is lax or non-functioning or when the PCL is absent. - The PS femoral component is intended for use in conjunction with the PS tibial insert where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability, or in conjunction with the constrained posterior-stabilized (PS-C) tibial insert where is instability of the lateral collateral ligament and/or medial collateral ligament (LCL/MCL). The Unity Total Knee System patellar component is optional and for use with either the CR or PS femoral variants and is intended for use where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments, tibial augments, stem extensions and offset adapters. The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the joint articulation where there is evidence of sufficient sound bone to seat and support the components. The Unity Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of Unity Knee MC Tibial Inserts. The additional range of tibial inserts has the same intended purpose as those cleared in the original 510(k) submission (K113060).

The Unity Knee™ PS-C Tibial Insert is intended for use in the Unity Total Knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components. The General total knee arthroplasty indications include: · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis · Post-traumatic loss of knee joint configuration and function - · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function - · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate - · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques - · The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface with - increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament The Unity Total Knee System is intended for cemented use, single use only.

The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, an ultra-high molecular weight polyethylene (UHMWPE) tibial insert, a CoCr tibial tray with a titanium alloy keel extension and all-polyethylene patellar component for use in primary and revision total knee arthroplasty. The Unity Total Knee System femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilised (PS). - The CR femoral component is intended for use in conjunction with the CR tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Condylar Stabilised (CS) tibial insert where the PCL is present but is lax or non-functioning or when the PCL is absent. - . The PS femoral component is intended for use in conjunction with the PS tibial insert where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability, or in conjunction with the constrained posterior-stabilized (PS-C) tibial insert where is instability of the lateral collateral ligament and/or medial collateral ligament (LCL/MCL). The Unity Total Knee System patellar component is optional and for use with either the CR or PS femoral variants and is intended for use where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments, tibial augments, stem extensions and offset adapters.

ApolloKnee is indicated to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee arthroplasty. Apollo Robot and BalanceBot are optional accessories and are specifically indicated for use in total knee arthroplasty with the ApolloKnee system. ApolloKnee is compatible with the following implant systems: - · Apex Knee™ System. - · Unity Knee™ System. ApolloKnee is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate.

ApolloKnee™ (formerly OMNBotics) is a robotic-assisted stereotaxic surgery system that aids the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee replacement (TKR). ApolloKnee is composed of eight sub-systems that integrate to form the ApolloKnee system. Four of these sub-components (Station, Tracking System, Communication Module and Nonsurgical Application) form the main structure of Corin's core platform for robotic or computer assisted surgeries. This core platform is referred to as "Apollo". Future Corin technologies are intended to be developed on the basis of the Apollo core platform. ApolloKnee is one such technology built upon the Apollo common platform. ApolloKnee includes four system specific sub-components (Apollo Robot, BalanceBot, TKR Instruments and ApolloKnee Software), ApolloKnee is an evolution of the former OMNIBotics Knee System. ApolloKnee is the first launched under Corin Ltd following acquisition of the OMNIBotics' prior manufacturer OMNIlife Science. ApolloKnee differs from OMNIBotics Knee System (as previously marketed under K200888) in branding (for commercial reasons), as well as redesigns of the station and software, and introduction of additional surgical instrumentation, namely the BalanceBot Pre-Resection Paddles, Tibial Cutting Guide and V-Array.

The indications for the Corin MetaFix™ Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemi-arthroplasty head, as a hip hemi-arthroplasty, include: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union and femoral neck fractures - Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH) The Corin MetaFix™ Hip Stem is indicated for cementless use only.

The MetaFix™ Hip is a tapered stem manufactured from titanium alloy (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The MetaFix™™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collared and collarless), a 125° standard offset (collared and collarless), a 125°short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads. The MetaFix™ hip is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

The MobiliTTM Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint: - In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis - -For patients who have a high risk of dislocation - In cases of necrosis of the femoral head - - In cases of fracture of the neck of the femur - - In cases of congenital luxation - The MobiliTTM Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup. The cementless MobiliTTM standard Cup, with flanges and hook are indicated for cementless use only. The cemented MobiliT™ Cup is indicated for cemented use only.

The MobiliT™ Cup is a modular system consisting of two articulating surfaces in the same joint space. The MobiliT™ Cup is a metal shell combined with a specific ECiMa™ insert. This system offers two articulating surfaces in the same joint space, one between the shell and the insert, the other between the insert and the femoral head. The shell is made of stainless with ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) insert. A Trinity™ femoral head 22mm or 28mm CoCr, or a 28mm BIOLOX® delta articulates within the ECiMa™ insert to allow for a second articulation. The MobiliTTM Cup is designed for use with any Corin 12/14 femoral stem. The MobiliT™ Cup is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components. The MobiliT™ Cup is intended to be used with the following approved devices: - 22mm and 28mm CoCr heads (K110087, K131647 and K170359) ● - 28mm BIOLOX® delta Ceramic Heads (K103120) .

The Revival™ Modular Hip Stem is indicated in revision surgery of femoral components, following failure of a primary cemented prosthesis. The Revival™ Modular Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival™ Modular Hip Stem include: - . Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis and hip dysplasia - Aseptic necrosis of the femoral head ● - Rheumatoid arthritis - Correction of functional deformity ● - Treatment of non-union and femoral neck fractures ● - Treatment of traumatic dislocations of the hip . - Failures of osteotomy ● - Treatment of arthrodesis . The Revival™ Modular Hip Stem is indicated for cementless, single use only.

The Revival™ Modular Hip Stem is a modular stem manufactured from titanium alloy (Ti6Al4V ELI) with a proximal component, a distal component and a locking screw. The modular proximal component is available in four lengths (40, 50, 60, and 70mm) and two CCD angles (125° and 135°). The distal component is conical in shape and has longitudinal fins. The distal component design has four lengths (100, 160, 200, and 240mm) and ten diameters (14, 15, 16, 17, 18, 19, 20, 21, 22, and 24mm). The proximal and distal components are assembled using a 'Morse' taper 2 '51' so that the proximal component can be dialed into position to achieve the anteversion required. The locking screw is used to assemble and hold the 'Morse' taper cone in place. The Revival stem has a surface finish obtained by abrasion with corundum to increase the contact surface for cementless fixation. The device is intended to be used with Corin (12/14 taper) modular heads. The Revival™ Modular Stem was originally cleared in K152903. This submission is being made to modify the indications for use to include a primary indication and to include additional sizes to the range.

The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. The BiPolar-i is intended for use in the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, - Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur - Revision of failed partial hip replacements in which the acetabulum does not require replacement The BiPolar-i is indicated for cementless use only.

The BiPolar-i is a preassembled bipolar head comprised of an ultra-high molecular weight polyethylene (UHMWPE) liner and a highly polished cobalt-chromium alloy (CoCr) outer shell. The BiPolar-i is used in combination with a 22mm or 28mm CoCr modular head (dependent on the BiPolar i size) and compatible hip stem, both supplied separately. When assembled, the modular head is maintained captive and articulates within the UHMWPE liner. The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. The BiPolar-i is intended for use with a Corin femoral head and hip stem prosthesis with a compatible 12/14 taper connection and is designed to articulate in the patient's natural acetabulum.