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The Signature Orthopaedics Freedom Cervical Screw and Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (C1 to C7) as an adjunct to fusion in the treatment of the following acute and chronic instabilities and deformities of the cervical spine: - traumatic spinal fractures and/or traumatic dislocations - instability or deformity; failed previous fusions (e.g. pseudarthrosis) - degenerative disease, including neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability, and - short term stabilization of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom expectancy is of insufficient duration to permit achievement of fusion.

The Freedom™ Posterior Cervical Screw System consists of screws, longitudinal rods and cross connectors in a variety of sizes to accommodate differing anatomic requirements. The cervical screws are inserted into adjacent vertebrae, then rods are clamped into the tulip of the pedicle screw using the cap screw, thus immobilising the instrumented vertebrae. The cross-connector may then be attached between rods to improve stability. The system components are made of Ti6Al4V alloy and are supplied sterile.

Components of the Signature Orthopaedics range of soft tissue fixation devices are intended to reattach ligament, tendon or soft tissue to bone. Specifically, the BI-ON Screw and Anchor, BI-ON Bio-screw and Bio-anchor, Vector Knotted, ATOK, Vortex Anchor, Dynaloc Anchor and Shoulder Suture Anchor are indicated for use in the shoulder, including: Shoulder - Capsular stabilization - Bankart Repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Acromioclavicular separation repairs - Deltoid repairs - Rotator cuff tear repairs - Biceps tenodesis

The Shoulder Soft Tissue Anchor System consists of a range of implants for soft tissue fixation to bone in the shoulder joint. The soft tissue anchors are manufactured from PEEK OPTIMA LT1 (ASTM F2026) or a PEEK/Hydroxyapatite composite and are available as knotted and knotless variants. Several of the soft tissue anchor variants are supplied preloaded with sutures and preassembled onto a driver. The UHMWPE (HS fibre) sutures are finished devices externally supplied by RiverPoint Medical and previously cleared through 510(k) K10006. All components are intended for single use only. The following variants are included in the range of Shoulder Soft Tissue Anchors: - Turbine Anchor - Mini Incision Anchor - Turbine OP Anchor - Vortex Anchor - Vector Anchor - DynaLoc Anchor - BI-ON Bio Anchor - Arthroscopic Transosseous Knotless (ATOK) Anchor

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, Origin TT, 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 Origin Cemented 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 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' Origin™ Cemented Hip Stems are manufactured from nitrogen stainless steel per ASTM F1568 and ISO 5832-9. The subject stem is straight and tapered with a lateral chamfer. The Cemented Origin™ stem is polished and intended for cemented use in total hip arthroplasty. It features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components including the Signature CoCr Femoral Heads (K121297 and K163081), Signature Ceramic Femoral Heads (K190704), Signature BiPolar Head (K133370 and K163081) and Evolve UniPolar Head (K143184). Compatible acetabular cups and liners including the Logical Cup (G-Series K121297, PX-Series K121297 and C-Series K153131) and the Logical Liners (Neutral and 10º Hooded, Lateralised K121297), Logical Liners (20º Hooded, Lateralised 20º Hooded K153131), Logical Constrained Liners (K153131) and Logical Liners Vit-E (Neutral and 10º Hooded, Lateralised, 20º Hooded, Lateralised 20º Hooded, High Wall, 10º Face Changing (K241690).

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 TT, 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), Origin Cemented 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 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 Signature Orthopaedics Origin™ TT Stem is intended for single use and cementless fixation. It is manufactured from titanium alloy as per ISO 5832-3 and has a proximal plasma spray coating of titanium as per ASTM F1580 and hydroxyapatite as per ISO 13779-2. It features a 12/14 taper and is compatible for use with Signature CoCr Femoral Heads (K121297 and K163081), Ceramic Femoral Heads (K190704), Logical™ PX, G and C Series Acetabular Cups (K121297 and K153131), Logical™ Liners (K121297, K153131 and K241690), Logical™ Constrained Liners (K153131), BiPolar Heads (K133370 and K163081) and Evolve™ UniPolar Heads (K143184).

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 ioint 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' World Cup components are intended for cementless fixation only.

The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the World Cup System (K201278 and K241690) is to notify the FDA of additional geometrical variants of the World liner available in crosslinked UHMWPE (XLPE) and Vitamin-E Stabilized, 100kGy crosslinked UHMWPE (Vit-E HXLPE) material options. The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded, lateralised, high wall, face changing and eccentric variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head.

The patient should be skeletally mature to receive a knee replacement. The Rx Knee System is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is intended for use in conjunction with systemic antimicrobial therapy (standard treatment approach to an infection). The device is intended for use with the gentamicin-loaded cement. Palacos® G. The Rx Knee System is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). The device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period, allowing basic joint mobility.

The Rx Knee System is a temporary knee device consisting of femoral, all polyethylene tibial and patellar components, with femoral and tibial augments and a tibial or universal stem to accommodate for variants in patient anatomy. The femoral component is available in posterior stabilised and cruciate retaining variants intended for use with corresponding all polyethylene tibia variants that have been previously cleared as part of Signature Orthopaedics' World Knee System via K181530. The femoral and tibial components have been previously cleared as part of Signature Orthopaedics' World Knee System via K181530, K220737 and K223062. All Rx Knee System components are intended for use with FDA-cleared gentamicin-loaded bone cement. The device is intended to be used for patients undergoing a two-stage revision procedure for infection of a total knee implant. The Rx Knee System components are sterile, single-use devices intended for temporary use as a total knee replacement. Materials: Cast Cobalt Chromium (CoCr) alloy (ASTM F75 and ISO 5832-4) for the femoral component, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) for femoral and tibial augment components, tibial stem, stem extension adapter and locking screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the femoral and tibial components and All-poly tibial components previously cleared as part of predicate World Knee System, and titanium nitride (TiN) diamond-like carbon (DLC) for coating femoral components which is the subject of FDA device master file no. 1647.

Logical Liner and World Liner: 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 intended 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 World Knee System: Patients 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 Orthopaedics' World Knee replacement components may be intended for cemented or cementless use.

The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the Logical Cup, World Hip, and World Knee System, is to notify the FDA of the the change in materials used to manufacture the polyethylene components (Logical Liner, World Liners and World Knee Patella) to Vitamin-E Stabilized, 100 kGy crosslinked UHMWPE (Vit-E HXLPE) that is the subject of Masterfile MAF 2795. This 510(k) also notifies the FDA of minor design updates to the implants and reusable instruments. The Logical Acetabular System consists of an Acetabular Shell and a highly cross-linked polyethylene Acetabular Liner that is available in neutral, hooded and lateralized variants. The liner is designed to sit within an acetabular shell and articulate with a femoral head. The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head. The World Knee Patella is available in symmetrical and asymmetrical variants, with pegs. It is part of the World Knee System, which is a modular knee system consisting of a femoral component, meniscal inert, a patella and a tibial component.

The VerteLoc Spinal System is indicated for use as a cervical vertebral body replacement (VBR) fusion device in the cervical spine (C3-C7) in skeletally mature patients for partial or total replacement of diseased, collapsed or unstable vertebral body due to tumour, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The VerteLoc Spinal System is to be used with bone graft material. The Vertel.oc Spinal System is intended for use with supplemental internal fixation that has been cleared by the FDA.

The Verteloc Spinal System is a modular vertebral body replacement (VBR) system intended to replace a diseased, collapsed, damaged or unstable cervical vertebral body following partial or total corpectomy. The VerteLoc device comprise of three components; two end bodies and one mid body, which when used in combination is used to replace a measured deficit in the patient's spine. The VerteLoc device is offered in a variety of footprints and heights to accommodate the needs of patients. When assembled, the central portion of the end and mid bodies create an inner hollow for the placement of autograft and/or autograft bone graft material. The VerteLoc device is manufactured from unreinforced PEEK OPTIMA LT1 as per ASTM F2026 with titanium pins as per ASTM F136 and ISO 5832-3 as well as tantalum marker beads as per ASTM F560 and ISO 13782. The VerteLoc Spinal System VBR is to be used in conjunction with supplemental fixation systems.

The Signature Orthopaedics PEEK RCI, Bio-Composite and SignaLoc Screws intended for use in fixation of soft tissue including ligament or tendon to bone for cruciate ligament reconstruction surgeries of the knee. The screws are also intended for use in the following procedures: - · ACL repairs - · PCL repairs - · Extra-capsular repairs - · Medial collateral ligament - Lateral collateral ligament - · Posterior oblique ligament - · Patellar realignment and tendon repairs - Vastus medialis obliquus advancement - · Illiotibial band tenodesis

The PEEK RCI, Bio-Composite and SignaLoc Screws are interference screws which provide compression of the graft or tendon to the bony wall for biological fixation of the ligament, tendon or soft tissue to bone. The screws feature an internal cannulation to accept a guide wire and have the same drive feature. The screws have an external variable thread along the length of the tapered shape and a rounded head. Each screw is provided individually packaged sterile for single use. The PEEK RCI is manufactured from unreinforced PEEK and the SignaLoc and Bio-Composite is manufactured from a PEEK/Hydroxyapatite composite.

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.