Search Results

The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: - Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - Congenital hip dysplasia. - Acute traumatic fracture of the femoral head or neck. - Certain cases of Ankylosis. - Dislocation of the hip. - Correction of functional deformity. - Revision of failed joint reconstruction or treatment. - Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur. Note: - · The Titanium coated Modular Shell is intended for press-fit, uncemented use only. - · The Hydroxyapatite Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only. - · The Proximally Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only. - · The Cemented Femoral stem is intended for cemented use only. - · The Modular Acetabular Liner is intended for use with Modular Acetabular Shell. · The CoCr Modular Femoral Head is intended to articulate with Modular Liner to mate with uncemented stem or cemented stem. • The Biolox® delta Modular Femoral Head is intended to articulate with Modular Liner and to mate with uncemented stem or cemented stem. · The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell. - · The Centralizer and Cement Restrictor are intended for use with cemented stem only.

The Latitud™ Uncemented Femoral Stem is fabricated from Titanium alloy - ELI (Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial). It has 12/14 taper at the top which mates with its 510(k) cleared Latitud™ Cobalt Chromium alloy and Biolox® delta Modular femoral head (Cleared under K172857). This stem is implanted without use of bone cement. Stem is coated with Hydroxyapatite (HA) by plasma spraying method. These stems are available in different sizes with neck angles of 135° standard, 135° lateral and 125° standard (Coxavera). Uncemented Femoral Stem is intended for press-fit uncemented use only.

The Opulent TiNbN Coated Knee is indicated for the following: · Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis. · Correction of functional deformities. · Post-traumatic loss of knee join contcularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. - · Moderate valgus, varus, or flexion trauma. - · Knee fractures untreatable by other methods. - · Revision surgery where sufficient bone and soft tissue integrity are present. The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Opulent TiNbN Coated Knee comprises of Femoral Component and Tibial Component as described below, - Femoral Knee Component CR and PS (Left and Right) . - . Tibial Component (Tibial Base Plate) Each of these components is described below. #### 5.7.1 Femoral Component The Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (Co-Cr-Mo), coated with Titanium Niobium Nitride (TiNbN). The Femoral Component is available in two designs: Cruciate Retaining (CR) and Posterior Stabilized (PS). Each of these designs is further classified into Left and Right configurations. Each Left and Right configuration is available in eight different sizes (A to H) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions. Thus, a total of thirty two (32) models are available for the Femoral Component. #### 5.7.2 Tibial Component (Tibial Base Plate) The Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum coated with TiNbN. The tibial base plate is available in eight different sizes from 1 to 8 based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

The Opulent TiNbN Coated Knee is indicated for the following: · Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis. · Correction of functional deformities. - · Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. - Moderate valgus, varus, or flexion trauma. - · Knee fractures untreatable by other methods. - · Revision surgery where sufficient bone and soft tissue integrity are present. The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Opulent TiNbN Coated Knee comprises of a Femoral Component and Tibial Component as described below, - Femoral Knee Component CR and PS (Left and Right) ● - Tibial Component (Tibial Base Plate) ● Each of these components is described below. These components are compatible with previously cleared components of the Destiknee Total Knee System (e.g., patellae, tibial inserts).

The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: - · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis. - · Rheumatoid arthritis. - Congenital hip dysplasia. - · Acute traumatic fracture of the femoral head or neck. - · Certain cases of Ankylosis. - Dislocation of the hip. - · Correction of functional deformity. - · Revision of failed joint reconstruction or treatment. - · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.

Latitud™ Hip Replacement System cleared under K172857 consists of modular acetabular cup system, femoral heads, femoral stems and related accessories. Purpose of this 510(k) is to add following acetabular cup system and femoral stem under previously 510 (k) cleared Latitud Hip Replacement System (K172857). - Latitud TM Triad Acetabular Cup System . - Latitud™ Proximally coated Uncemented femoral stem . Latitud™ Triad - Acetabular Cup System is a modular cup system. It includes Modular shells, Modular liners and Bone screws. - . Modular Shell: Modular shells are intended for uncemented, press fit fixation with prepared acetabulum. They are designed for use with Modular liners. The Modular shells are fabricated from Ti-6Al-4V-ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Modular shells are available in different sizes. The outer surface of the Modular shell is coated with commercially pure Titanium. - Modular Liner: Modular liners are designed to be used with Modular shell. Modular liners . are intended to be articulated with a range of dedicated Cobalt chromium alloy or Biolox® delta Modular femoral heads previously cleared under K172857. Modular liners are fabricated from Highly Cross-Linked Polyethylene (HXLPE). It is available in different sizes. - Bone Screw: Bone screw is used if additional fixation of Modular shell is required. Bone . screw is self tapping and is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Bone screw is available in 6.5 mm diameter with different lengths. The proximally coated uncemented femoral stem is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Femoral head (CoCr and Biolox Delta ceramic) previously cleared under K172857. The proximal portion of the stem is coated with commercially pure Titanium with plasma spray method. The proximal coated femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design). Each design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).

The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components. Total hip replacement is indicated for the following conditions: - · Non-inflammatory degenerative joint diseases including osteoarthritis, post-traumatic arthritis and avascular necrosis. - · Rheumatoid arthritis. - Congenital hip dysplasia. - · Acute traumatic fracture of the femoral head or neck. - · Certain cases of Ankylosis. - Dislocation of the hip. - · Correction of functional deformity. - · Revision of failed joint reconstruction or treatment. - · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur. Note: - · The Titanium coated Modular Shell is intended for press-fit, uncemented use only. - · The Hydroxyapatite coated Uncemented Femoral Stem is intended for press-fit, uncemented use only. - · The Cemented Femoral stem is intended for cemented use only. - The Modular Acetabular Liner is intended for use with Modular Acetabular Shell. - · The CoCr Modular Femoral Head is intended to articulate with Modular Liner to mate with uncemented stem or cemented stem. - The Biolox® delta Modular Femoral Head is intended to articulate with Modular Liner and to mate with uncemented stem or cemented stem. - · The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell. - · The Centralizer and Cement Restrictor are intended for use with cemented stem only.

The Latitud™ Hip Replacement System consists of following components: Acetabular Cup System - > Modular Shell / Cup - > Modular Liner - > Cobalt Chromium Modular Femoral Head - > Biolox® delta Modular Femeral Head Femoral Stem - > Uncemented Femoral Stem - > Cemented Femoral Stem Accessories (Sub components) - > Bone Screw - > Apical Hole Occluder - > Centralizer - > Cement Restrictor Acetabular cup system is a modular acetabular replacement system consisting of a range of Modular Shells, Modular Liners, Cobalt chromium alloy and Biolox® delta Modular Femoral Heads. The Modular Shells are designed for use with dedicated sizes of Modular Liners articulating with a range of dedicated Cobalt chromium alloy and Biolox® delta Modular Femoral Heads. Modular Shell: Modular Shell is intended for uncemented, press fit fixation with prepared acetabulum. They are designed for use with Modular liners. The Modular shell is fabricated from Ti-6Al-4V-ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Modular shell is available in different sizes. The outer surface of the Modular shell is coated with commercially pure Titanium. Two/Three screw holes are provided in Modular shell for additional immediate fixation with bone by means of Bone screws. A threaded apical hole is provided to attach instruments for surgical insertion. After fixation of Modular shell, apical hole will occlude by Occluder. Modular Liner: Modular liner is designed to be used with Modular shell and articulate with a range of dedicated Cobalt chromium alloy or Biolox® delta Modular femoral heads. Modular liner is fabricated from Highly Cross-Linked Polyethylene (HXLPE). It is available in different sizes. Cobalt chromium Modular Femoral Head: Modular femoral head fabricated from cobalt chromium alloy is designed to mate with 12/14 taper of femoral stem through taper-locking arrangement and to articulate with Modular liner. It is available in different sizes with different offsets. Biolox® Delta Modular Femoral Head: Modular femoral head fabricated from ceramic material (Biolox® delta, by CeramTec. Germany) is designed to mate with 12/14 taper of femoral stem through taper-locking arrangement and to articulate with Modular liner. It is available in different sizes with different offsets. Uncemented Femoral Stem: The Uncemented femoral stem is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). It has 12/14 taper at the top which mates with Cobalt chromium alloy and Biolox® delta Modular femoral head. This stem is implanted without use of bone cement. Stem is coated with Hydroxyapatite (HA) by plasma spraying method. These stems are available in different sizes with three different neck angles. Uncemented femoral stem is intended for press-fit uncemented use only. Cemented Femoral Stem: Cemented femoral stem is fabricated from High Nitrogen Stainless Steel (HNSS). It has 12/14 taper trunnion at the top which mates with Cobalt chromium alloy and Biolox® delta Modular femoral head. This stem is implanted with use of bone cement. These stems are available in different sizes with two different offsets. Cemented stem is intended for cemented use only. Accessories (Subcomponents): Bone Screw: Bone screw is used if additional fixation of Modular shell is required. Bone screw is self tapping and is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Bone screw is available in 6.5 mm diameter with different lengths. Apical Hole Occluder: Apical hole occluder is provided to occlude the apical hole after fixation of the Modular shell in acetabulum. Apical hole occluder is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Apical hole occluder is available in one size. Centralizer: Centralizer is used for correct positioning of Cemented stem in medullary canal of femur. Centralizer is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE). Centralizer is designed to be used with Cemented stem only. Centralizer is offered in two sizes. Cement Restrictor: Cement restrictor is used to occlude and seal intramedullary canal in order to generate sufficient pressure to enhance cement penetration and to prevent distal cement leakage. Cement restrictor is designed to be used with Cemented stem only. Cement restrictor is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE). Cement restrictor is provided in two sizes.

ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as: - comminuted fractures - supracondylar fractures - extra-articular fractures - fractures in osteopenic bone - nonunions - malunions Smaller-sized ARMAR™ / ARTISTM plates are used for small bones and small fragments of the hands and feet. ARMARTM / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous. ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSSTM/FIXIONT™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna. ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically, - Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia. - Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, - L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and - Proximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia. ARMAR™ / ARTISTM 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomnies of the distal radius and other small bones in adults. ARMARTM / ARTISTM Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. ARMARTM / ARTISTM Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula. ARMARTM / ARTISTM Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

The Meril Healthcare Trauma System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The Trauma System utilizes medical grade stainless steel and titanium. Trauma System implant are provided clean and non-sterile with instructions for steam sterilization. The instruments are provided non-sterile and are reusable. The implants are provided nonsterile and are single use only.

The DestikneeTM Total Knee System is indicated for patients with severe knee pain and disability due to: · Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, polyarthritis. · Correction of functional deformities. · Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy. · Moderate valgus, varus, or flexion trauma. · Knee fractures untreatable by other methods. The Destiknee™ Total Knee System is intended for cemented use only. This device is for single use only.

The Destiknee™ Total Knee System is a system of components intended to replace the Femoral, Tibial and Patella articular surfaces of the knee joint. The components are available in many styles and sizes and are manufactured from metallic and non-metallic materials. The Destiknee TM Total Knee System was originally cleared under 510(k): K160771. The purpose of current submission is to add Tibial Base Plate (size 7 and size 8) and All Poly Patella (size 37mm and 40mm) in Destiknee™ Total Knee System.