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The DePuy Attune Total Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The subject device is a polyethylene tibial inserts and patella component made from AOX Polyethylene that mates with existing cemented and noncemented femoral and tibial base components

The TruMatch Patient Specific Instruments are intent-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting. The anatomical landmarks necessary for the TruMatch Patient Specific Instruments must be present and identifiable on CT. The TruMatch Patient Specific Instruments are intended for use with Sigma Total Knee Implants and Attune Total Knee Implants and their cleared indications for use. The TruMatch Patient Specific Instruments are intended for single use only. Intended for patients with osteoarthritis who: Meet the criteria for primary total knee replacement performed with a measured resection technique. Have mild bone deformities and/or angular deformities less than 15 degrees of fixed varus/valgus, or flexion. Have some previous implants, such as hip implants, ankle implants, and soft tissue anchors. Contralateral knee replacement is acceptable as long as the contralateral knee is flexed away (not within the same medial/lateral axis) from the knee of interest during the CT scan.

The TRUMATCH Personalized Solutions System is comprised of patient-specific instruments and the software utilized to design the patient-specific surgical plans and instruments. The predicate TRUMATCH System creates a surgical plan based on a mechanical axis surgical technique. Changes to the Planning software component allow the surgeon to select a mechanical axis surgical technique or a patient-specific alignment surgical technique. Upon approval of the surgical plan, the TRUMATCH Guides are manufactured according to the plan.

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 Summit DuoFix Hip is identical to the previously cleared Titanium Porocoat Hip stem (K170339, K011489, K001911) except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface. The Summit DuoFix Hip is a non-modular, collarless, Titanium, tapered, press-fit femoral stem. The hip stem is manufactured from ASTM F-620-87 forged Titanium (Ti-6Al-4V) and has a sintered commercially pure Titanium bead porous coating (Porocoat®) applied to the stem. The porous coating is applied over the circumferential ridges on the proximal region of the stem. A thin coating of hydroxyapatite (HA) is sprayed over the porous coating in a uniform thickness via a plasma spray process. The HA powder used in the plasma spray process conforms to ASTM F1185-88 and ISO 13779-6 Hydroxyapatite (Ca5(PO4)3OH) ceramic. The plasma spray process to apply the HA coating to the Summit DuoFix Stem is the same process used to coat the Pinnacle Duofix Acetabular Cup which was cleared in K192919. The HA material used for the Summit DuoFix Stem is the same as the HA material used on the Pinnacle Duofix Acetabular Cup. The distal portion of the stem has a grit blast surface finish. The hip stem consists of 10 body sizes ranging in diameter from 7 mm to 18 mm with each body size having two offset options. The design is a medially rounded trapezoid with a longitudinal ridge to optimize distal rotational stability. The Summit DuoFix hip stem uses a 12/14 taper for attachment of femoral ball heads. Femoral ball heads are intended to be used with the Summit DuoFix Hip prosthesis to provide the femoral prosthetic articular surface for the total hip arthroplasty. The femoral head articulates with an acetabular cup prosthesis that functions to restore mobility of the hip.

The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.

The Pinnacle Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®) hemispherical outer acetabular shell manufactured from titanium alloy (Ti-6Al-4V) with a thin layer of hydroxyapatite (HA) coating applied. The interior of the acetabular cup is designed with a groove and a taper for use with either an ultra-high molecular weight polyethylene (UHMWPE) or metal acetabular cup liner, which lock into the shell. Articulation occurs between the liner, and a femoral head with the appropriately sized diameter. The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to occlude the apical hole in order to prevent particulate migration and provide polyethylene support. The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole” (Sector series) configurations.

Total hip replacement or hip arthroplasty 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, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankyloses. Partial hip replacement or hip hemi-arthroplasty 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 hip hemi-arthroplasty. HA coated stems of the Corail Hip system are indicated for cementless use only.

The DePuy Corail AMT hip stem family are manufactured from forged titanium alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail AMT stems are available with or without a collar, with various neck angles, and with various neck offsets.

Candidates for total or unicompartmental knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant. In candidates for unicompartmental knee arthroplasty, only one side of the medial or lateral compartment) is affected. The Sigma® C/R Porocoat® Femoral Components are intended for cementless use as the femoral component of a Total Knee Replacement system. In the US, all other porous coated components have been cleared for CEMENTED USE ONL Y. Any Non-Porous coated components are intended for CEMENTED USE ONLY.

A total knee prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant, with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges. The patella component may be of an all polyethylene design or may be a metal backed polyethylene component.

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 treated fixation. 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 SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only. The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.

The Summit Hip System is series of tapered femoral hip stems which may be used in either total or hemi-hip arthroplasty procedures in conjunction with DePuy hip arthroplasty devices. The Summit Porous Hip Prosthesis is a series of collarless, titanium, tapered, press fit femoral stems The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only. The Summit DuoFix Porous Hip Prosthesis is a series of collarless, titanium alloy, tapered, press-fit femoral stems. The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem with a thin layer of hydroxyapatite (HA) coating. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only. The Summit Cemented Hip Prosthesis is series a flanged, collared tapered Cobalt-Chromium femoral stems with a smooth finish. There are seven proportional body sizes with a standard offset, and six proportional body sizes with a high offset. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal. These stems are intended for cemented use only. The Summit Basic Cemented Hip Prosthesis is a series of flanged, collared, tapered Cobalt-Chromium-Molybdenum femoral stems with a smooth surface finish. There are seven total sizes with a constant offset. Only six of the seven sizes are available in the high offset option. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. These stems are intended for cemented use only. The Summit Basic Press Fit Hip Prosthesis is a series of collared, tapered Titanium femoral stem with a grit-blasted finish. There are seven sizes with a constant offset and a distal centralizer to assure that the stem is centered in the femoral canal. These stems are intended for uncemented use only.

Total hip replacement or hip arthroplasty is indicated in the following conditions: 1. A severely painful and/or disabled joint from 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, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 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 hip hemi-arthroplasty. The Actis DuoFix Hip Prosthesis is indicated for cementless use only.

The DePuy Actis DuoFix prostheses are manufactured from forged titanium alloy (Ti-6Al-4V) and have a sintered commercially pure titanium bead porous coating (Porocoat®) and thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hemi-arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.

The DePuy Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from 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. The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.

The DePuy Pinnacle ALTRX Acetabular Liners are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6Al-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter. The subject devices represent additional sizes and style combinations of the predicate acetabular liners.