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The indications for the Trinity Acetabular System 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) or congenital dysplasia of the hip (CDH) The Trinity Acetabular System is intended for cementless, single use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium allov shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The purpose of this submission is to add 32mm (+7mm offset), 36mm (+8mm offset), and 40mm (+8mm offset) CoCrMo and BIOLOX delta™ ceramic extralong femoral heads to the Trinity Acetabular System.

The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include: - . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur - Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip . (CDI-I) The Corin Metafix Hip Stem is intended for cementless use only.

The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL6V4) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-03(2009). The Corin Metafix Hip Stern is available in 10 sizes marked 1 through 10. Each size is available in three offsets, including Standard (1359), Lateralized, (135°), and Standard (125°) apart from the size 1 which is available in two offsets, Standard (135°) and Lateralized (135°). The Corin Metafix Hip Stem was originally cleared in K082525, K120362 & K121439. The purpose of this submission is to modify the labeling to include additional contraindications for the Metafix stem when used for hemi arthroplasty, for clarity to ensure safe or effective use. The indications and components for use with the Corin Metafix stem subject of this submission are identical to that of the predicate devices K082525, K120362 & K121439.

The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur - 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 Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL6V4) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatic conforming to ASTM F-1185-03(2009). The stem is currently available in nine sizes (2-10), each available in three offsets including Standard (1359), Lateralized 135°, and Standard (125°). The Corin Metalix Hip Stem was originally cleared in K082525. This submission is for one additional stem size, size 1 in two available offsets, Standard (1359 and Lateralized 135°. Like the originally cleared Metafix Stems, the additional stem size features a low profile lateral shoulder, a tapered metaphyseal flare as well as a vertically and horizontally grooved stem, providing for rotational and axial stability. The indications and compatible components for use with the Corin Metafix size 1 are identical to that of the predicate devices (K082525 & K120362).

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 evidence of sufficient sound bone to seat and support the components. 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 procedure, where soft tissue stability is adequate - Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques - The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament The Unity Total Knee System is indicated for cemented, single use only.

The Corin Unity Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee System is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The Unity posterior stabilized variant is utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity system patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides augment components including femoral wedges, tibial wedges, a short keel extension and stem extensions with offset connections.

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

The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL,V ) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-03(2009). The stem is indicated for use with Corin CoCr modular femoral heads and ceramic modular femoral heads with a 12/14 taper. (NOTE : the ceramic modular heads are not subject of this 510(k) submission.) The stem is available in nine sizes, each available in three offsets including standard (135°), lateralized 135°, and standard (125°). The Corin Bipolar Head (K925897) is comprised of an outer CoCr shell, an inner liner of ultra high molecular weight polyethylene (UHMWPE), and an inner CoCr head. The Bipolar head is available in a range of outer diameter sizes and a variety of head offsets and is compatible with all Corin 12/14 taper femoral stems. The Corin Optimom Modular Head (K111911) is a polished, truncated CoCr alloy sphere with a high tolerance internal female taper and is available in a range of diameters with a variety of offsets. It is compatible with Corin 12/14 taper titanium and stainless steel femoral stems. The Bipolar and the Optimom Modular Heads are indicated for hip hemi-arthroplasty. The purpose of this submission is to modify the labeling for the Metafix Femoral Hip Stem to include hip hemi-arthroplasty to the indications for use when the stem is mated with a Corin CoCr hemi-arthroplasty femoral head.

The indications for the Trinity Acetabular System 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) or congenital dysplasia of the hip (CDH) The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell, acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW, ceramic and Co-Cr modular heads and titanium femoral stems. The purpose of this submission is to add ECIMA acetabular liners to the Trinity Acetabular System. Corin's ECIMA is a cold irradiated, mechanically annealed, vitamin E blended ultra high molecular weight polyethylene.

The Corin Optimom Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required. The device is intended for prescription use only.

The Corin Optimom Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is a device modification of the internal female taper of the Corin Unipolar Modular Heads (K063791) to provide for compatibility with an additional range of Corin femoral hip stem designs with a 12/14 male taper. The materials and dimensions of the internal female taper are substantially equivalent to the CoCr Modular Heads cleared in K003666 and K010243 and the Trinity Modular Heads cleared in K110087. The Optimom Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm with a variety of offsets.

The indications for the Trinity Acetabular System as a total hip arthroplasty include: - o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis o - o Correction of functional deformity - Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) o The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell (48mm through 68mm in 2mm increments) for use with ultra high molecular weight polyethylene (UHMWPE) liners (28mm and 32mm inner diameters in neutral, +4mm offset, EPW and 10° hooded designs) and a dedicated range of 28mm and 32mm modular 12/14 taper femoral heads providing ceramic (i.e., zirconia and Biolox delta in the USA) or metal on UHMWPE articulation for use in total hip replacement procedures using Corin titanium femoral stems with a 12/14 taper connection. The acetabular shell is coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The acetabular shell is provided with screw holes permitting the use of dedicated titanium bone screws to provide additional fixation if required. Titanium occluders are provided to occlude unused screw holes and an apical introducer hole. The purpose of this submission is to modify the labeling for the Trinity Acetabular System to include additional Corin titanium femoral stems with a 12/14 taper connection as compatible components, intended for use with the Trinity Acetabular Cup and Liner and the Trinity CoCr Femoral Heads. The Trinity Acetabular System is intended for use in 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 indications for the Trinity Acetabular System 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) and congenital dysplasia of the hip (CDH) The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell (48mm through 68mm in 2mm increments) for use with ultra high molecular weight polyethylene (UHMWPE) liners (28mm and 32mm inner diameters in neutral, +4mm offset and 10° hooded designs) and a dedicated range of 28mm and 32mm zirconia and cast cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic or metal on UHMWPE articulation for use in total hip replacement procedures using Corin Tri-fit femoral stems with a 12/14 taper connection. The UHMWPE is previously cleared. The acetabular shell is coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The acetabular shell is provided with screw holes permitting the use of dedicated titanium bone screws to provide additional fixation if required. Titanium occluders are provided to occlude unused screw holes and an apical introducer hole. The Trinity Acetabular System is intended for use in 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 indications for the MiniHip Stem as a total hip arthroplasty include: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - DDH/CDH - Revision procedures where other treatments or devices have failed - Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The MiniHip Stem is indicated for cementless use only.

The MiniHip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAIsV4) alloy and is proximally coated with plasma sprayed hydroxyapatite over plasma sprayed pure titanium in order to enhance primary fixation. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in six sizes, each with the provision of a 130° CCD (Caput-Collum-Diaphysis) neck angle with a polished distal section for guidance and to minimize distal fixation and reduce proximal stress-shielding.