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Mfinity femoral stems are indicated in patients requiring hip arthroplasty. Total or partial hip arthroplasty is indicated in the following cases: - Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia. - Avascular necrosis of the femoral head. - Acute fracture of the femoral head. - Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty. - Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty. - Primary pathology involving the femoral head but with a non-deformed acetabulum. - Failure of previous hip surgery: - Conservative hip surgery. - Internal fixation. - Arthrodesis. - Partial or total hip arthroplasty. - Hip resurfacing replacement.

The Mfinity Femoral System includes implantable devices provided individually packed, sterile and single-use intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The product range is composed of three different versions (Mfinity collarless, Mfinity collared and Mfinity L) available in standard and lateral offset. The Mfinity femoral stem can be combined with the CoCr ball head (K072857, K080885 and K103721), Endo Head (K111145), the MectaCer BIOLOX® forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518). The subject devices are made of titanium alloy according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite according with ASTM F1185.

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The subject device is a set of smaller stems that extends the size range of the previously cleared Trivicta® stems (K233758). Trivicta® is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta® is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The size range of the subject device is: lengths (97-101mm), horizontal offsets (36-43mm), vertical offsets (27-29mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta® is compatible with the following Ortho Development® devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

1. Non-inflammatory degenerative joint disease Including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. This device is a single use implant and intended for cementless use only.

Resolve Modular Revision Hip Stem is a modular stem optimized for femoral primary or revision surgery. It consists of three main components: (1) Resolve Proximal Component (two types: With Hole or No Hole, each available with HA/Ti plasma spray or Ti plasma spray coating) (2) Resolve Distal Stem (four types: Taper Stem, Clothespin Stem, Clothespin With Hole Stem, and Interlocking Stems. Taper Stem is uncoated; others are available with HA/Ti plasma spray or Ti plasma spray coating. Clothespin With Hole Stem and Interlocking stem provide holes for additional Distal Interlocking Screw fixation.) (3) Resolve Distal Interlocking Screw (used with Resolve Clothespin With Hole Stem and Interlocking stem) Resolve Modular Revision Hip Stem can be used with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185). All components are manufactured from Ti-6Al-4V alloy (ASTM F136). The coatings (HA/Ti plasma spray and Ti plasma spray) comply with ASTM F1580 and ASTM F1185, ISO 13779-6. Proximal components have standard and high offset designs.

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.

The proposed Exactech Alteon HA Femoral Stems are intended for press-fit hip arthroplasty. The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V ELI (per ASTM F136, ASTM F620) with a grit blast surface and HA coating (per ISO 13779-2). The stem has a 12/14 taper. The Alteon HA Femoral Stems are available in various lengths with standard and extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces. The Alteon HA Femoral Stems are compatible with the same femoral components as the predicate: - Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392) - Exactech Ziramic Zirconia Femoral Heads (K050398, K060107) - Exactech BIOLOX forte Alumina Femoral Heads (K032964, K051682) - Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters (K103012,K121392) - AcuMatch L-series Unipolar endoprostheses (K010081) - AcuMatch L-Series Bipolar Endoprostheses (K013211) . The Alteon HA Femoral Stems are compatible with the same acetabular components as the predicate: - AcuMatch A-Series Acetabular Shells and Liners (K993082, K042906) - AcuMatch A-Series Acetabular GXL Liners (K051556) - AcuMatch A-Series Acetabular Cups, All-polyethylene, Cemented (K963313) - Novation Crown Cup Acetabular Shells and Liners (K070479, K100269, K121392, K141960) - Novation Crown Cup Acetabular Shells with InteGrip (K102975) - Novation Crown Cup Constrained Liners and Rings (K071676) - Exactech Integrip Acetabular Shells (K122798) - Exactech Novation and AcuMatch E-HXL Acetabular Liners (K173583) - Exactech Alteon Acetabular Cup System (K182502)

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 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)

TheRay Collared and Collarless Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: • A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia; · Acute traumatic fracture of the femoral head or neck; · Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement. TheRay Collared and Collarless Total Hip System femoral stems are intended for cementless fixation. The acetabular cup is intended for cementless fixation. The porous structured surfaces on the acetabular cup provide biological fixation in a cementless application. The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stem or TheRay Collared or Collarless Femoral Stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: · Femoral neck and trochanteric fractures of the proximal femur; · Osteonecrosis of the femoral head; · Revision procedures where other devices or treatments for these indications have failed.

TheRay Collared and Collarless Hip System includes the new subject femoral stems, along with previously cleared femoral heads (K161184, K220336), acetabular cups (additively manufactured – K161184 and K191936), acetabular liners (vitamin E polyethylene – K161184), acetabular bone screws (K161184), screw hole covers for the screw holes in the acetabular cups (K161184), and apical hole covers for the acetabular cups (K161184). The subject femoral stem implant features a forged triplaner Ti-6Al-4V ELI substrate and an applied dual coating comprised of plasma-sprayed commercially pure titanium (CPTi) and hydroxyapatite (HA). The collared version of the subject TheRay Femoral Stem features a collar on the medial aspect of the stem above the coating that is designed to seat on the native resected calcar. The collarless version of the subject TheRay Femoral Stem is identical to the collared version, less the medial collar. The iNSitu Bipolar Hip System has been previously cleared for use in K191297 and consists of a factory assembled UHMWPE (ASTM F648) liner in a cobalt chrome (ASTM F75) outer shell, and UHMWPE (ASTM F648) retention ring with a Ti-6Al-4V ELI (ASTM F136) spring. These Bipolar Heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller Bipolar Heads (38 to 43 mm) have an inner diameter that mates with a 22mm diameter Femoral Head; the larger Bipolar Heads (44 to 60 mm) have an inner diameter that mates with a 28 mm diameter Femoral Head. The iNSitu Bipolar Hip System may be used in conjunction with the subject TheRay Collared and Collarless Hip System Femoral Stems.

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.

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Trivictal is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The stem has a variety of sizes to accommodate most patients encountered: lengths (101-119mm), horizontal offsets (38-53mm), vertical offsets (29-36mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta™ is compatible with the following Ortho Development devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Hemi hip replacement is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

The submission covers a portfolio of hip implants including Hip Stems, Acetabular Shells and Liners, Femoral Heads, and Hip Components. Specific device descriptions are provided for various product families within these categories, detailing materials, designs, and available sizes.