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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: - · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - · Inflammatory joint disease including rheumatoid arthritis - Correction of functional deformity including congenital hip dysplasia - · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture · Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement - · Dislocation risks (when used with SignaSure range) Signature Orthopaedics' Origin. Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only. Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation. Signature Orthopaedics' constrained liner components are indicated particularly for patients at hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: - Acute femoral head or neck fracture - Fracture dislocation of the hip - Avascular necrosis of the femoral head - Non-union of femoral neck fractures - · Certain high subcapital and femoral neck fractures in the elderly - · Degenerative arthritis involving only the femoral head

The SignaSure Dual Mobility System is available in two configurations, a Monobloc configuration and a Modular configuration. The Monobloc configuration is a Dual Mobility acetabular system consisting of a metallic shell, cemented, and a mobile polyethylene insert to articulate within the shell as a femoral head. The Modular configuration (subject device) is a dual mobility acetabular system consisting of 2 components; a mobile polyethylene component and a metallic insert which can be used with interfacing cemented or cementless cups. The SignaSure Poly, used in both configurations, is manufactured from highly crosslinked polyethylene (as per ASTM F648) and is spherical in geometry with outer and inner spherical conforming articular surfaces. The inner articular surface mates and retains a femoral head. The outer articular surface articulates within the highly polished inner diameter of the SignaSure Cementless or Cemented Cup to be used, or the metallic insert. The SignaSure Poly components are available in size 37 to 41 mm (outer diameter) allowing use with 22 mm and 39 to 59 mm femoral heads. The SignaSure Logical Insert is manufactured from Cobalt Chrome (CoCr) alloy (as per ASTM F1537 and ISO 5832-12) and mates with Signature Orthopaedics' Logical Shell to be implanted without bone cement and the SignaSure World Insert is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and mates with Signature Orthopaedic's World Cup to be implant without bone cement. The SignaSure Logical Insert is available in 34 to 48 mm sizes whereas the SignaSure World Insert is available in 38 to 46 mm (internal diameter) sizes. The SignaSure Cementless Cup is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and is sequentially plasma sprayed with titanium coating (as per ASTM F1580) and hydroxyapatite (as per ISO 13779-1 and ISO 13779-2) to gain cementless fixation. The SignaSure Cemented Cup is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and is grit blasted and macro textured to aid in fixation via bone cement. These cups, as from K211742, underwent no changes and were included in this submission as they interact with the subject SignaSure Poly devices.

The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions: - . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. - Inflammatory degenerative joint disease including rheumatoid arthritis. - Functional deformity such as varus, valgus or flexion deformities. - . Revision procedures where other treatments or devices have failed. - . Fractures that are unmanageable using other techniques. Signature Orthopaedic's World Knee replacement components may be intended for cemented or cementless use. Please verify whether the particular component is intended for cemented or cementless use by checking the package label. The intended use of the World Total Knee System is for total knee replacement procedures in skeletally mature patients with structural joint damage. This is the same intended use as previously cleared devices for the World Total Knee System, K181530.

The World Total Knee System is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate or all polyethylene tibia. The femoral component and tibial baseplate components are intended for use with or without bone cement. The femoral component, meniscal inserts and all polyethylene tibias are available as posterior stabilised or cruciate retaining variants. The femoral components are also available as anatomic asymmetrical and symmetrical design variants. The femoral component may be used with modular pegs. The primary purpose of this Special 510(k) Device Modification to the World Knee System is to notify the FDA of the addition of titanium nitride (TiN) material coating to the femoral components (posterior stabilised{PS}, cruciate retaining{CR}) of the cemented variant. This 510(k) also notifies the FDA of minor design update to the femoral component implant. Materials: Cast Cobalt Chromium (CoCr) alloy (ASTM F75 and ISO 5832-4) for the femoral component and tibial baseplate, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) for the femoral peg component and tibial baseplate variant, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) for all variants of the patellar implants, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the All-poly tibial baseplate components and modular meniscal tibial inserts, and titanium nitride (TiN) for coating cemented femoral components.

The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions: - Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis. - Inflammatory degenerative joint disease including rheumatoid arthritis. - Functional deformity such as varus, valgus or flexion deformities. - Revision procedures where other treatments or devices have failed. Signature Orthopaedics' TriVerse Total Knee Replacement System components are indication only.

The TriVerse Total Knee System is a modular total knee replacement (TKR) system consisting of a femoral component, meniscal inserts, a locking bar for the meniscal insert, a patella and a tibial baseplate with a tibial post and bolt. The femoral component and meniscal insert locking bar is manufactured from cobalt chrome. The femoral component are available as posterior stabilise and cruciate retaining variants, while meniscal inserts are available as posterior stabilised, posterior stabilised plus, cruciate retaining and anterior stabilised variants. All variants of the meniscal inserts as well as the patella components are manufactured from Vitamin-E Stabilized UHMWPE (HXLPE). The tibial post component is available as an I-Beam or Finned keel variant. The tibial base plate, bolt and post components are manufactured from titanium alloy.

The Signature Orthopaedics' TLC Unicompartmental Knee comprising the femur component, tibial component and meniscal inserts is designed for a single compartment of the natural knee joint. The TLC Unicompartmental Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The TLC Unicompartmental Knee system is a modular knee system consisting of a femoral component, meniscal insert and a tibial baseplate. The femoral component is manufactured from cast cobalt chromium alloy and are intended for use with bone cement. The tibial baseplate component is manufactured from titanium alloy and intended for use with bone cement. The meniscal insert is manufactured from UHMWPE.

The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions: - · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. - · Inflammatory degenerative joint disease including rheumatoid arthritis. - · Functional deformity such as varus, valgus or flexion deformities. - · Revision procedures where other treatments or devices have failed. - · Fractures that are unmanageable using other techniques. Signature Orthopaedic's World Knee replacement components may be intended for cemented or cementless use. Please verify whether the particular component is intented for cementless use by checking the package label.

The World Knee Total Knee System is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate or all polyethylene tibia. The femoral component and meniscal inserts are available as posterior Stabilized or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. The tibial baseplate components covered in this 510(k) is made of Titanium as part of the cemented version. The patella components are available in a spherical or non-symmetrical designs. The primary purpose of this Special 510(k) Device Modification to the World Knee System is to notify the FDA of the change in materials used to manufacture the tibial inserts (all variants (CR, PS and UC) of modular meniscal insert and all-poly tibial baseplate components) to Vitamin-E Stabilized, 100 kGy crosslinked UHMWPE (Vit-E HXLPE). This 510(k) also notifies the FDA of minor design updates to the implants and reusable instruments. Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (ASTM F1537-11) for the femoral component, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) for the tibial baseplate components, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) for all variants of the patellar implants, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the Allpoly tibial baseplate components and modular meniscal tibial inserts.

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treat, the devices are indicated for: - · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - · Inflammatory joint disease including rheumatoid arthritis - · Correction of functional deformity including congenital hip dysplasia - · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - · Failed previous hip surgery including internal fixation, reconstruction, hemiatthroplasty, surface replacement, or total replacement Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, World and Encore femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only. Signature Orthopaedics' SignaSure Insert is indicated for use with the cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation. Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: - · Acute femoral head or neck fracture - · Fracture dislocation of the hip - · Avascular necrosis of the femoral head - · Non-union of femoral neck fractures - · Certain high subcapital and femoral neck fractures in the elderly - · Degenerative arthritis involving only the femoral head

The SignaSure Dual Mobility System consists of cementless and cemented shells, and a poly component. The SignaSure Poly is manufactured from crosslinked polyethylene and is spherical in geometry with outer and inner spherical conforming articular surfaces. The inner articular surface mates and retains a femoral head. The outer articular surface articulates within the highly polished inner diameter of the SignaSure Cementless or Cemented Cup. The SignaSure Cementless Cup is manufactured from CoCr alloy and is sequentially plasma sprayed with titanium coating and hydroxyapatite to gain cementless fixation. The SignaSure Cemented Cup is manufactured from CoCr alloy and is grit blasted and macro textured to aid in fixation via bone cement.

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: - Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - . Inflammatory joint disease including rheumatoid arthritis - . Correction of functional deformity including congenital hip dysplasia - . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, World and Encore Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only. Signature Orthopaedics' SignaSure Insert is indicated for use with a cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation. Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: - . Acute femoral head or neck fracture - Fracture dislocation of the hip - Avascular necrosis of the femoral head - Non-union of femoral neck fractures - . Certain high subcapital and femoral neck fractures in the elderly - . Degenerative arthritis involving only the femoral head

Signature Orthopaedics' Encore Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Encore Stem is straight and tapered with a rectangular cross-section. The stem has a polished distal tip to reduce fixation leading to proximal stress shielding. It features a titanium and hydroxyapatite plasma spray proximal coating below its resection line.

Signature Orthopaedics' Fusion Taper System is intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: - . Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - . Inflammatory joint disease including rheumatoid arthritis - . Correction of functional deformity including congenital hip dysplasia - . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemi-arthroplasty, surface replacement, or total replacement Signature Orthopaedics' Fusion Taper System is intended for cementless fixation only.

The Fusion Taper System consists of modular femoral heads and taper sleeves. The Fusion Taper Sleeve is manufactured from Ti6Al4V as per ISO 5832-3. The Fusion Ceramic Head is manufactured from an alumina matrix as per ISO 6474-2. All Fusion Heads are intended for total hip arthroplasty. The Fusion Heads connect to the femoral stem via a Fusion Taper Sleeve which has a 12/14 inner taper and 16/18 outer taper. Signature Orthopaedics Fusion Taper System is indicated for use with Signature Ti6A14V femoral stems: TSI Stem (K102172), Origin Stem (K121297. K161155), Aria Stem (K121297), Remedy Stem (K133370), Spartan Stem (K192883), World Stem (K201278), and acetabular components: Logical Cup (K121297, K153131), Logical Liners (K121297), Logical 20deg Hooded Liners including lateralised variants (K153131), World Cup (K201278), and World Liner (K201278).

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: - . Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - Inflammatory joint disease including rheumatoid arthritis . - . Correction of functional deformity including congenital hip dysplasia - . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, and World Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only. Signature Orthopaedics' Evolve. Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only. Signature Orthopaedics' SignaSure Insert is indicated for use with a cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation. Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: - Acute femoral head or neck fracture . - Fracture dislocation of the hip . - . Avascular necrosis of the femoral head - . Non-union of femoral neck fractures - . Certain high subcapital and femoral neck fractures in the elderly - Degenerative arthritis involving only the femoral head

Signature Orthopaedics' World™ Hip Stem is a circular tapered stem with longitudinal ribs intended for single use and cementless fixation in total hip arthroplasty. The stem is manufactured from forged Ti6Al4V alloy as per ASTM F136. It features a grit blasted body and a 12/14 taper connection with the trunnion surface roughness as Rz 2.5, which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components. Signature Orthopaedics' World™ Acetabular Cups are metal backed cementless acetabular cups with highly cross-linked polyethylene liner intended for use in total hip arthroplasty. The shells are available in a three hole configuration, which allows use of supplemental bone screws for supplemental fixation. The World™ Acetabular Cups are compatible with WorldTM Liners. Signature Orthopaedics' World™ Liners are designed to articulate with a femoral head of appropriate diameter. The liners are available in neutral, 10° hooded and 20° hooded, allowing the option to address potential joint stability concerns.

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the devices are indicated for: - · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - · Inflammatory joint disease including rheumatoid arthritis - · Correction of functional deformity including congenital hip dysplasia - · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - · Failed previous hip surgery including internal fixation, reconstruction, hemiarthroplasty, surface replacement, or total replacement Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems are intended for cemented fixation only. Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: - · Acute femoral head or neck fracture - Fracture dislocation of the hip - · Avascular necrosis of the femoral head - Non-union of femoral neck fractures - · Certain high subcapital and femoral neck fractures in the elderly - · Degenerative arthritis involving only the femoral head

The purpose of this 510(k) application is to extend the compatibility of the subject devices between Signature Orthopaedics and Encore Medical components. The subject devices themselves have not undergone any changes.