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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. Total hip systems may be indicated for use (i) without bone cement, or (ii) for use with or without bone cement. Refer to the product labeling and literature for specific applications. The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only. The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture. Acetabular Hip Components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, congenital dysplasia. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocations of the hip. The Constrained Liners are indicated for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The purpose of this Traditional 510(k) is the following: - 1. To add the MR safety information to the product labels and update the MR information within the package insert for the Smith & Nephew Hip Systems included within the scope of this 510(k), and - 2. To address several iterative legacy design changes made to the subject hip system components.

The Stryker Global Modular Replacement System, Modular Replacement System and Modular Rotating Hinge Knee Component are sterile, single-use devices intended for use in situations where there is a need for replacement of bone due to radical bone loss. This loss can be related to oncology, trauma or failed previous prosthesis. Specific Indications for Use are listed below. Indications for the MRS Stems and Intercalary Stems (presented in K952970): - This device is intended for use in patients requiring extensive reconstruction of the femur . and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement. - The Intercalary System is intended for use in situations arising from femoral mid-shaft tumor resection, or for prosthetic knee fusion. Indications for the Global Modular Replacement System (presented in K023087): - Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581): - Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement. Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217): Proximal femoral reconstruction secondary to: o Trauma o Failed previous prosthesis o Tumor resection Indications for the Modular Replacement System Cemented Stems (presented in K040749): Femoral and/or proximal tibial replacement due to: o Trauma o Failed previous prosthesis o Tumor resection Indications for the Modular Rotating Hinge Knee System (presented in K002552): - The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue. Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.

The Global Modular Replacement System (GMRS) is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System (MRS) or the Modular Rotating Hinge Knee System (MRH). The Modular Rotating Hinge Knee System is a tricompartmental knee system. The system consists of a stemmed femoral component and a stemmed tibial bearing component connected by a set of bushings and an axle. The MRH Tibial Rotating component is a part of the MRH system and mates with the GMRS Standard Proximal Tibia. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis.

DALL-MILES Cable System The DALL-Miles System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach. The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only. The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation. The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device. The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies. Femoral Heads The indications for use for total hip and hemi hip arthroplasty include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed; and, 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Femoral Mesh The indications for use for total hip and hemi hip arthroplasty include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed; and, 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Surgical Mesh. Surgical Mesh is intended to be used to reinforce bone or tissue in any situation where additional strengthening and support is required due to poor bone/tissue quality. Intramedullary Plug, Centralizer The indications for use of total hip replacement prostheses include: · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; · rheumatoid arthritis; · correction of functional deformity; · revision procedures where other treatments or devices have failed; and, · treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement. The EXETER 2.5mm Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement. Exeter X3 RimFit Cups The indications for use for total hip arthroplasty include: 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. 4. Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. The Exeter X3 RimFit Cup is intended for cemented use only. Femoral Stems The indications for use for total hip and hemi hip arthroplasty include: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The devices covered by this bundled submission are Stryker Total Hip Systems which include Dall-Miles cable system components, femoral heads, femoral mesh, Intramedullary Plug, Centralizer, acetabular cups, and femoral stems. All devices are commercially available and have been cleared in prior 510(k) submissions.

Indications for the MRS Stems and Intercalary Stems (presented in K952970): · This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement. · The Intercalary System is intended for use in situations arising from in femoral mid-shaft tumor resection. or for prosthetic knee fusion. Indications for the Global Modular Replacement System (presented in K023087): · Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581) · Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement. Indications for the Modular Replacement System Cemented Stems (cleared in K040749): · Femoral and/or proximal tibial replacement due to: - Trauma - Failed previous prosthesis - Tumor resection

The Global Modular Replacement System is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System or the Modular Rotating Hinge Knee System. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis. The subject Global Modular Replacement System components are unchanged since the last premarket notification for the devices in K222056.

The Stryker Global Modular Replacement System components are sterile, single-use devices intended for use in situations where there is a need for replacement of bone due to radical bone loss. This loss can be related to oncology, trauma or failed previous prosthesis. Specific Indications for Use are listed below. Indications for the MRS Stems and Intercalary Stems presented in K952970: - This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement. - . The Intercalary System is intended for use in situations arising from femoral mid-shaft turnor resection, or for prosthetic knee fusion. Indications for the Global Modular Replacement System presented in K023087: - . Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217): - Proximal femoral reconstruction secondary to: 0 - Trauma o - Failed previous prosthesis о - Tumor resection O Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581) - Femoral replacement in Oncology cases where radical resection and replacement of bone is . required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement. Indications for the Modular Replacement System Cemented Stems (cleared in K040749): - Femoral and/or proximal tibial replacement due to: ● - Trauma O - Failed previous prosthesis O - Tumor resection o Indications for the Modular Rotating Hinge Knee System (cleared in K002552) The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue. Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.

The Global Modular Replacement System is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System or the Modular Rotating Hinge Knee System. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis.

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. The C-Stem AMT LE Hip Prosthesis is indicated for cemented use only.

The C-Stem AMT LE Hip Prosthesis is a collarless, triple-tapered, cemented femoral stem designed to be used as one component of a system of prostheses in hip arthroplasty. It is manufactured from wrought stainless steel conforming to ISO 5832-9 (Ortron-90®) and is polished overall. It is designed to be used with commercially available modular femoral heads, either metal or ceramic. The subject device is compatible with DePuy acetabular shells and liners. The C-Stem AMT LE Hip Prosthesis is a line extension of the predicate C-Stem AMT Hip Prosthesis cleared under 510(k) numbers K042959 and K082239. The subject C-Stem AMT LE Hip Prosthesis and the predicate C-Stem AMT Hip Prosthesis are comprised of identical materials and share common design features, including a polished full-length triple tapered intramedullary geometry, 12/14 Articul/EZE Mini Taper and a raised lateral shoulder.

The indications for use for total hip arthroplasty include: - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late-stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. - Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. The Exeter X3 RimFit Cup is intended for cemented use only.

This submission covers the subject Exeter X3 RimFit Cups, terminally sterilized by gas plasma (GP) or ethylene oxide (EtO). The Exeter X3-GP RimFit Cup, terminally sterilized by gas plasma (GP), was previously cleared in K193429 and K111848. It features three subcomponents: a cup manufactured from X3 UHMWPE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from SG-10 PMMA. The Exeter X3-EtO RimFit Cup, terminally sterilized by ethylene oxide (EtO), was previously cleared in K193429. It features three subcomponents: a cup manufactured from X3 UHMWE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from TS2270 PMMA. The subject Exeter X3-GP RimFit Cup and Exeter X3-EtO RimFit Cup are compatible for use with Stryker Orthopaedics V40 femoral heads, universal taper femoral heads, and C-Taper femoral heads as previously cleared in K111848. The purpose of the submission is to modify the labeling to remove a contraindication for obesity.

MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use. MicroPort total hip systems 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 ioint disease such as rheumatoid arthritis: 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed Rough grit blast surfaces and the hydroxyapatite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. LINEAGE® and DYNASTY® modular shells with porous metal bead coating are intended only for uncemented arthroplasty. PRIME shells are intended only for uncemented arthroplasty.

The device modification consists of an alteration to the sterilization instructions for FDAcleared MicroPort Orthopedics' (MPO) non-sterile hip orthopedic joint replacement instruments. The subject instruments are part of MicroPort Orthopedics' hip product lines and are required to facilitate total hip arthroplasty procedures. The modification will allow the option to sterilize the subject instruments using an FDA-cleared containment device. The subject devices will be placed in an FDA-cleared containment device, which will be wrapped in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material, and then steam sterilized. The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device. The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices.

VerSys Cemented Revision/Calcar is indicated for total hip arthroplasty in patients: Whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.

The VerSys CRC Hip System includes femoral stems and build-up blocks that are permanent hip implants and provided sterile via gamma irradiation. The VerSys CRC Hip System include femoral stems in a variety of body sizes and lengths and build-up blocks in heights of 10mm, 20mm, and 30mm. The block is attached to the femoral stem by inserting two Tivanium® Ti-6Al-4V alloy screws into the holes provided. Only one build-up block can be attached to a femoral stem The modular connection of the femoral stem is a Morse-type 12/14 taper designed to mate with the corresponding bore of a femoral head.

ELEOSTM Limb Salvage System Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions : 1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity 4) Revision procedures where other treatments or devices have failed; and, 5) Treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and or total femur is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment: 2) Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. - 3) Metastatic diseases ELEOSTM Limb Salvage System Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and 5) Treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions: 1) Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. 3) Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male mid-section, resurfacing hinge femur, and proximal tibia, optional components include modular collars, patella, stem extensions, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.