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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 and Grit-Blasted stems are intended for cementless use only. The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only. The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty. b-ONE® Total Hip System components are not intended for use with other total hip systems.

b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The b-ONE KOSMO Femoral Stems Sizes are offered in 12 femoral stem sizes ranging from size 0 to 10 with half size of 4.5 for Cementless Collared Standard, High, and Proportional Offset families and 11 femoral stem sizes ranging from size 1 to 10 with half size of 4.5 for Cementless Collarless/Collared Coxa Vara families and Cemented Standard and Proportional Offset families. The subject stems are laser marked with the catalog number, company logo, size, and material. The KOSMO Femoral Stem is composed of titanium alloy Ti-6A1-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stems. The cementless stems are offered as either HA coated or Grit-blasted. The b-ONE Cement Restrictor is made from UHMWPE (ASTM F648/ISO 5834-1). The restrictor is offered in 7 different sizes with a major diameter of 9, 11, 13, 15, 17, 20, and 23mm and have a total length of 17mm. The cement restrictor is to be used for cement implantation. This b-One Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.

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 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 MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial tray, 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. This submission is to add a Stemmed Baseplate with modular Stem Extension options. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies. The b-ONE MOBIO Total Knee System Stemmed Tibial Baseplates are manufactured from forged titanium alloy. The baseplates are offered in 9 sizes with medial lateral dimensional range from 58-85mm and anterior posterior dimensional range from 58-85mm and anterior posterior dimensional range from 38-59mm. The baseplate is intended for cemented fixation. The Stemmed Baseplates mate with stem extensions through a threaded junction. The Tibial Stems are manufactured from forged titanium alloy. The Tibial Stems are offered in 3 diameters (12, 14, and 16mm) with various lengths ranging from 20-120mm. The stems are intended for cemented fixation. All system components are supplied sterile and are single use devices.

The 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 the PS and PS+: - Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or nonfunctioning posterior cruciate ligament - Severe anteroposterior instability of the knee joint The MOBIO Total Knee System is intended for implantation with bone cement only. MOBIO Total Knee System components are not intended for use with other knee systems.

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial tray, 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 purpose of this submission is to introduce a line extension to the b-ONE™ MOBIO™ Total Knee System CR/CR PLUS Tibial Insert components and PS/PS PLUS Tibial Insert Components. Compatibility with the b-ONE™ MOBIO™ Total Knee System tibial baseplate and femoral components remains the same. There is no allowed interchangeability with systems manufactured by other companies. The subject b-ONE™ MOBIO™ Tibial Inserts are made from UHMWPE GUR® 1020-E Crosslinked with .1% tocopherol and conventional UHMWPE GUR® 1020. This material is the same as that used in the reference and predicate devices. The pre-assembled locking wire is the same locking wire used in the existing Tibial Inserts and is manufactured from Cobalt Chrome conforming to ASTM F90. All system components are supplied sterile and are single use devices.

The OneFix Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, BLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. The OneFix Biocomposite Small Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot. ankle, knee, hand, wrist, elbow, shoulder, and hip. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral repair The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In con junction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue. The OneFix Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction. The OneFix Cannula System is introduction of instrumentation through a portal for surgical procedure.

The OneFix Biocomposite Anchors consist of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 96 model codes over 4 families. The anchors widths range from 3.0mm through 6.5mm and lengths of 11.9mm through 16.8mm. The OneFix Biocomposite Small Anchors consist of cannulated anchors with an eyelet. They are preloaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 9 model codes corresponding to variations of sutures with anchor dimensions (11.9mm x 2.4mm x 3.0mm). The OneFix All Suture Anchors consist of one "fixed suture" and 2 or 3 non-absorbable sutures. The non-absorbable suture is manufactured from UHMWPE and PET fibers. The OneFix All Suture Anchor is implanted using its self-punching option and are pre-loaded on a handled insertion device. They come in 14 various model codes. The OneFix Biocomposite Interference Screws are inserted into the bone tissue and the external thread is screw shaped and the inside of the screw is start shaped. The screws are manufactured from PLGA copolymer and ß-TCP. There are 36 model codes with outside diameter ranging from 7-12mm and 20-35mm lengths. The OneFix Cannula Systems is intended to puncture through tissue to make a pathway for surgical instruments during surgery. It consists of a cannula and a trocar made of polycarbonate. There are 3 types of this product: threaded, smooth and all smooth and comes in 72 model codes with inside diameter of 4.3mm through 8.1mm and lengths of 84mm through 130mm. All implant components are provided sterile and are designated as single use. The system also includes the reusable surgical instruments required for implantation.

The 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 standard fracture- management techniques Additional Indications for the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+): - · Ligamentous instability requiring implant bearing surface geometries with increased constraint - · Absent or nonfunctioning posterior cruciate ligament - · Severe anteroposterior instability of the knee joint The MOBIO Total Knee System is intended for implantation with bone cement only. MOBIO Total Knee System components are not intended for use with other knee systems.

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, 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. This submission is to add a condylar stabilizing (CR+) Tibial Insert device type to the system. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies. The CR PLUS Tibial Inserts are offered in a total of 50 sizes, size A/1-3 through HJ/8-10, with 10 thicknesses ranging from 9 to 25mm. 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. All system components are supplied sterile and are single use devices.

The 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 standard fracture- management techniques Additional Indications for the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+): - · Ligamentous instability requiring implant bearing surface geometries with increased constraint - · Absent or nonfunctioning posterior cruciate ligament - · Severe anteroposterior instability of the knee joint The MOBIO Total Knee System is intended for implantation with bone cement only. MOBIO Total Knee System components are not intended for use with other knee systems.

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, 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. This submission is to add a cruciate retaining (CR) device type to the system, including the CR femoral component and corresponding CR Tibial inserts. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies. The MOBIO Total Knee System includes left and right femoral components for the Cruciate Retaining (CR) system. These components are manufactured from cast cobalt chrome conforming to ASTM F75. 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. Fixed femoral pegs on the femoral components provide additional medio-lateral fixation. The CR Tibial Inserts are offered in a total of 50 sizes, size A/1-4 through HJ/7-10, with 10 thicknesses ranging from 9 to 25mm (total thickness with Tibial Baseplate is 9 to 25mm). 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. All system components are supplied sterile and are single use devices.