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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.

The ONVOY Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from: 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 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. 6. Dislocation risks. The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

The ONVOY™ additional implants consist of acetabular shells, liners, and dual mobility liners and bearings that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. New femoral head sizes are also being introduced. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster-hole design, liners are available in hooded, non-hooded, and lateralized designs used in conjunction with ONVOY shells. Dual mobility polyethylene bearings are used with dual mobility liners. ONVOY™ acetabular shells are additively manufactured from titanium alloy powder per ASTM F3001. Acetabular liners and dual mobility bearings are manufactured from highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Dual mobility liners are manufactured from Cobalt Chrome (CoCr) alloy and femoral heads are manufactured from alumina matrix composite ceramic.

The DePuy RECLAIM Monobloc Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

The subject devices in this line extension to the RECLAIM Monobloc Revision Femoral Stem (previously cleared through Primary Predicate 510(k) K221462 and with MRI Conditional status cleared through 510(k) K231873) include four new Standard length RECLAIM Monobloc Revision Femoral Stems and twenty-three new Short length RECLAIM Monobloc Revision Femoral Stems. The line extension will extend the DePuy RECLAIM Monobloc Revision Femoral Stems portfolio by twenty-seven product codes. The Subject Device RECLAIM Monobloc Revision Femoral Stems are revision implants that are intended to treat patients with prior failed hip replacement devices. They are made of Ti6Al4V alloy and present a grit-blasted tapered fluted intramedullary region with splines that are intended to be in interference of the previously reamed femoral cavity and in contact with the cortical bone in the canal in an uncemented use.

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.

General Indications: The MobileLink Acetabular Cup System is indicated for mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. Indications: - Primary and secondary osteoarthritis - Rheumatoid arthritis - Correction of functional deformities - Avascular necrosis - Femoral neck fractures - Revision after implant loosening dependent on bone mass and quality Dual Mobility Insert (in addition to the indications and general indications): - Dislocation risk The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell. Additional indications specific to the TrabecuLink Augments: - Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. MobileLink PlasmaLink and TiCaP Shells: The MobileLink System consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either titanium plasma sprayed (TPS) coating (brand name: PlasmaLink) or a double coating consisting of titanium plasma spray coating plus calcium phosphate (CaP) coating (brand name: TiCaP). The MobileLink PlasmaLink and TiCaP Shells are compatible with polyethylene liners (K182321, K241636), acetabular bone screws (K192559), Dual Mobility Inserts (K200607) with BiMobile Dual Mobility Liners (K171273, K190535), Shell/Insert Adapters ("Face Changers", K200607), and TrabecuLink Augments (K241636).

NEXUS® Hip stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed Titanium plasma spray and HA coatings applied to implant surfaces are intended for uncemented arthroplasty.

The MicroPort NEXUS® Hip Stem is manufactured from titanium alloy (Ti6Al4V per ASTM F620) and includes titanium plasma sprayed coating conforming to ASTM F1580 and a hydroxyapatite (HA) coating conforming to ASTM F1185. The proximal body of the hip stem has a dual titanium and HA plasma spray coating while the distal portion of the hip stem has HA coating only. The NEXUS Hip Stem features collared and collarless options and sizes 0 through 12 with standard and high offsets. The NEXUS Hip Stem is provided sterile and is a single use device. The subject NEXUS Stems are compatible with previously cleared MicroPort femoral head and shell/liner components.

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).

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.

Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries. Mpact 3D Metal Augments are indicated in cases of: - Acetabular dysplasia; - Acetabular fractures; - Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.

The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user. The devices subject of this submission are: - Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924; - Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3. The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.

The Zimmer Biomet Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. When used with constrained acetabular liners, the Zimmer Biomet Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

The Zimmer Biomet Ceramic Heads are made from a composite ceramic containing approximately 75% alumina (Al2O3) and 25% zirconia (ZrO2) (percentage by weight). They are supplied with a 12/14 bore or a Type 1 bore. The scope of the subject submission is limited to the 22.2mm head diameter with multiple neck configurations. The subject ceramic heads are intended for mating with Ti-6Al-4V alloy, Ti-6Al-7Nb alloy stems with tapered necks. They may only be used in combination with highly crosslinked or conventional polyethylene (PE) or metal-back polyethylene liners.