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The b-ONE™ Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), 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 and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip. The b-ONE™ Total Hip System KOSMO™ HA coated stems are intended for cementless use only. The b-ONETM Total Hip System KOSMOTM stainless steel stems are intended for cemented use only. b-ONETM Total Hip System components are not intended for use with other total hip systems.

The b-ONE Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; optional acetabular bone screws. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE Total Hip System. There is no allowed interchangeability with systems manufactured by other companies. This 510(k) premarket notification is being submitted as a line extension to the current b-ONE Total Hip System by adding a bone compacting Femoral Stem component. The KOSMO™ Femoral Stem is compatible with the b-ONE™ Primary Acetabular components. The KOSMO™ Cementless Femoral Stem components are compatible with the b-ONE™ 12/14 Taper CoCr or Ceramic Femoral Heads. The KOSMO™ Cemented Femoral Stem components are compatible with the b-ONE™ 12/14 Taper Ceramic Femoral Heads only. b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The KOSMO Femoral Stem is composed of HA coated titanium alloy Ti-6Al-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stem. All system components are supplied sterile and are single use devices.

The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), 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 and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection: and fracture-dislocation of the hip. The b-ONE® Total Hip System is intended for cementless use only. b-ONE® Total Hip System components are not intended for use with other total hip systems.

The b-ONE™ Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; and, optional 6.5mm acetabular screws. Acetabular Shell options include no-hole and multiple hole configurations. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE® Total Hip System. There is no allowed interchangeability with systems manufactured by other companies. The Tapered Wedge Stem and Acetabular Shells are made from Ti-6A1-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. The subject devices are identical to the predicate devices, with the exception that there has been an additional supplier qualified for coatings. All system components are supplied sterile and are single use devices.

The b-ONE MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions: · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis. · Post-traumatic loss of knee joint configuration and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Revision of previous unsuccessful knee replacement or other procedure. · Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture- management techniques. Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components: · Ligamentous instability requiring implant bearing surface geometries with increased constraint. - · Absent or nonfunctioning posterior cruciate ligament. · Severe anteroposterior instability of the knee joint. The b-ONE MOBIO Total Knee System is intended for implantation with bone cement only. b-ONE MOBIO Total Knee System components are not intended for use with other knee systems.

The b-ONE™ MOBIO™ Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies. The purpose of this submission is to add a line extension to the existing system to offer the Tibial Inserts and Patella components in UHMWPE Crosslinked with 0.1% tocopherol. All system components are supplied sterile and are single use devices.

The b-ONE Total Knee System is intended for total knee arthroplasty due to the following conditions: · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis, · Post-traumatic loss of knee joint configuration and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Revision of previous unsuccessful knee replacement or other procedure. - · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques. Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components: - · Ligamentous instability requiring implant bearing surface geometries with increased constraint. - · Absent or nonfunctioning posterior cruciate ligament. - · Severe anteroposterior instability of the knee joint. The b-ONE Total Knee System is intended for implantation with bone cement only. b-ONE Total Knee System components are not intended for use with other knee systems.

The b-ONE Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device type and includes two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies. The System includes left and right femoral components manufactured from cast cobalt chrome. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Optional modular distal pegs are included in the system. The system includes a Patella Component offered in seven sizes of variable diameter and thicknesses. The bone fixation surface incorporates three fixation pegs. The Patella Components are made from Conventional UHMWPE. The system includes Tibial Inserts which are offered in 40 sizes, size A/1-4 through HJ/7-10 with 8 thicknesses and 48 sizes for PS+ inserts, size A1-2+ through HJ/7-10+ with 8 thicknesses. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy. The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy. All system components are supplied sterile and are single use devices.

The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis and congenital dysplasia: treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip. The b-ONE® Total Hip System is intended for cementless use only. b-ONE® Total Hip System components are not intended for use with other total hip systems.

The b-ONE® Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; and, optional 6.5mm acetabular screws. Acetabular Shell options include no-hole and multiple hole configurations. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE® Total Hip System. There is no allowed interchangeability with systems manufactured by other companies. The Tapered Wedge Stem, Acetabular Shells, and Acetabular Bone Screws are made from Ti-6AI-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. Femoral heads are made from CoCr or Ceram Tec Biolox® delta. Acetabular Shell Liners are made from conventional UHMWPE and UHMWPE with Vitamin E. All system components are supplied sterile and are single use devices.