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This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function. Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis Avascular necrosis of the femoral condyle Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy Moderate valgus, varus or flexion deformities Rheumatoid arthritis Treatment of fractures that are unmanageable using other techniques.

The 3DKnee™ porous coated femoral component is manufactured from CoCr alloy conforming to ASTM F75. The inner surface is porous coated with CoCrMo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in 7 sizes (2-12) and is provided in left and right configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is the same design as the 3DKnee™ cleared in K020114.

This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function. Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis Avascular necrosis of the femoral condyle Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy Moderate valgus, varus or flexion deformities Rheumatoid arthritis Treatment of fractures that are unmanageable using other techniques.

The 3D Knee is comprised of a femoral and a tibial component. The femoral component is manufactured from CoCr alloy conforming to ASTM F75, is available in 6 sizes (2-12) and is provided in left and right configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is similar to the Foundation Knee cleared in K923277. The 3D Knee tibial inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) that conforms to ASTM F648. The tibial inserts are available in 6 sizes (2-12) and 5 thicknesses (9-19) and are provided in right and left orientations. The tibial in design to the Foundation Lateral Pivot Insert cleared in K000590. This insert is intended to more closely complement the kinematics of the resurfaced knee, allowing rotation about the lateral condyle and increased congruency of the lateral condyle. The baseplate attachment mechanism is the previously cleared Foundation Knee System inserts; therefore, the attachment strength is the same.

Intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.

The Uni Knee is comprised of a femoral and a tibial component. The femoral component is manufactured from CoCr alloy conforming to ASTM F75. The femoral component is available in 4 sizes (S, M, L, XL) and provided in two configurations (left medial/right lateral and right medial/left lateral). The Uni Knee System tibial components are manufactured from ultra high molecular weight polyethylene (UHMWPE) that conforms to ASTM F648. The tibial inserts are available in 4 sizes (29-37 mm) and 3 thicknesses (7-9 mm).

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used as a posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intended for hook fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondification disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The PASS Spinal System consists of pedicle screws, rod-plates, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The additional components that are the subject of this Special 510(k) submission are 04.5mm polyaxial pedicle screws and crosslinks (Exhibit I). The pedicle screws are the same design as the polyaxial screws cleared in K001024. The crosslinks are nut, rod and clamp assemblies that hook onto the rods of the assembled PASS Spinal System (K001024) to provide torsional stability to the construct.

The indications for use of the total hip replacement prosthesis 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, which is unmanageable using other techniques. This stem is to be pressfit.

The Keystone® Hip System is available in a variety of proximal bodies and distal stem diameter and length configurations. The proximal body and stem are attached via a Morse type taper junction with an axially loading screw providing secondary attachment. The bodies, stems, and fixation screws were cleared on 510(k) K000521. All components are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F136 with a porous coating that conforms to ASTM 1854-98 applied to the proximal body. The additional components that are the subject of this Special 510(k) submission are the calcar replacement bodies and calcar build-ups. The calcar replacement bodies are to be used either with or without a calcar build-up. During revision surgery or treatment of intertrochanteric fractures, the medial calcar bone is often deficient. This implant allows the surgeon to rest the calcar platform of the stem on the remaining medial bone. The modular build-up is available in a +15 and +30mm height for each size stem. The build-up is attached to the stem using an attachment screw. The modular buildups are fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136. The attachment screw is used to attach the calcar build-up to the calcar replacement bodies. The attachment screw is fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

The indications for use of the Cemented Calcar Hip System in total hip replacement prosthesis include: 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, which is unmanageable using other techniques. The Cemented Calcar Hip Stem is intended for use with bone cement.

The Cemented Calcar Hip Stem is fabricated from wrought titaniumaluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136. The Cemented Calcar Hip Stem is available in sizes 12-16, which have diameters from 10-14mm and lengths of 18-20cm. The proximal body is polished and designed with filleted holes for cerclage cables. The distal and lateral portions of the stem are gritblasted. The Cemented Calcar Hip Stem is designed with a 1320 neck angle and a Morse taper to accept the femoral head. The distal portion of the stem tapers to accept a distal centralizer. The Cemented Calcar Hip Stem is to be implanted either with or without a collar. The modular collar is available in a +15 and +30mm height for each size stem. The collar is attached to the stem using an attachment screw. The modular collars are fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136. The attachment screw is used to attach the collar to the Cemented Calcar hip stem. The attachment screw is fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spines: spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used as a posterior, non-cervical, non-pedicle screw fixation system, the PASS Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis), tumor, pseudarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The subjects of this submission are the addition of polyaxial crosslink components for the PASS Spinal System. The subjects of this submission are the addition of polyaxial crosslink components for the PASS Spinal System. The polyaxial crosslink components are manufactured from titanium alloy per ASTM F136. The hooks can be used for single or multiple level fixation. The polyaxial hooks have the same attachment mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175. The laminar hooks are inserted inferior and superior around the pedicles. The hooks are available in standard and double lamination with a superior offset. The double lamination hooks can be inserted inferior and superior around the pedicles with a pedicle screw assembly without any problem of superimposition. The laminar hooks are inserted under the lamina and the polyaxial hooks are inserted under the pedicle. The polyaxial hooks are available from 0 to 30 degrees and the double lamination hooks can be inserted under the lamina with a pedicle screw assembly without any problem of superimposition.

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological imparment, fracture, soliocations, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by auto genouville graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The subjects of this Special 510(k) submission are the addition of polyaxial crosslink components for the PASS Spinal System (K001024). All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The hooks can be used for single or multiple level fixation. The polyaxial hooks have attachment mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175. The laminar hooks are inserted inferior and superior around the polyaxial pedicle hooks are inserted inferior and superior around the pedicles. The double laminar hooks are available in standard and polyaxial configurations. The low profile of the hooks allows it to be used in conjunction with a pedicle screw assembly without any problem of superimposition. The laminar hooks are inserted under the lamina and the polyaxial pedicle hooks are inserted under the pedicle. The low profile of the hook allows it to be used in conjunction with a pedicle screw assembly without any poblem of superimposition.

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The subjects of this Special 510(k) submission are the addition of rod-plate components for the PASS Spinal System (K001024). All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136. The rod-plates are similar to the rods as they consist of a short rod segment that has enlarged portions at the ends with holes to attach directly to the screws with hemispherical nuts rather than connecting the rod to the screw via a clamp. The proximal end is circular is shape with a circular hole, while the distal end is oval in shape with an oval opening that allows vertical variability of the distal screw placement. These components are offered in two versions (two or three holes) for one or two level instrumentation, each being available in two sizes, small and large. Rod-plates are present to match the lumbar lordosis.