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The Klassic® Knee System is intended for prosthetic replacement of the following: - · Patient conditions of non-inflammatory degenerative joint disease (NID); avascular necrosis and osteoarthritis - · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis - · Patients with failed previous surgery where pain, deformity, or dysfunction persists - · Correctable varus-valgus deformity and moderate flexion contracture - · Revision of a previously failed knee arthroplasty - · Patients who require a total knee replacement The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, with Cobalt 3D®, the Klassic Tibial Baseplate with Ti-Coat®, and the Universal™ Cones with Ti-Coat® which are also indicated for cementless use.

The Klassic® Tibial Baseplate, Revision (Ti6Al4V) is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty.

The Klassic® Knee System is intended for prosthetic replacement in treatment of the following: - Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis - Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis - Patients with failed previous surgery where pain, deformity, or dysfunction persists - Correctable varus-valgus deformity and moderate flexion contracture - Revision of a previously failed knee arthroplasty - Patients who require a total knee replacement The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.

The Klassic® Knee System is being updated with additional thicknesses of Tibial Inserts, PS-Post and Additional All Poly Tibia PS-Post implants. Both proposed geometries are fabricated from both Standard Poly and Vitamin E UHMWPE (E-Link).

The Klassic® Revision System is intended for prosthetic replacement in treatment of the following: - · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis - Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis - · Patients with failed previous surgery where pain, deformity, or dysfunction persists - · Correctable varus-valgus deformity and moderate flexion contracture - · Revision of a previously failed knee arthroplasty - · Patients who require a total knee replacement The Klassic® Revision System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.

The Klassic® Revision System is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty. The Klassic® Revision System includes the following implants and implant materials: Klassic® Stem Extension, Femoral, Cemented (Ti6Al4V), Klassic® Stem Adapter, Femoral (Ti6A14V), Klassic® Posterior Femoral Augment (Ti6A14V), Klassic® Distal Femoral Augment (Ti6Al4V), Klassic® Tibial Augment (Ti6Al4V, UHMWPE), Posterior Femoral Augment Set Screw (Ti6A14V), Distal Femoral Augment Set Screw (Ti6Al4V), Universal Cone™ with Ti-Coat (Ti6A14V and unalloyed Ti powder).

The Klassic HD Hip System is intended for prosthetic replacement without bone cement in treatment of the following: - · Patient conditions of non-inflammatory degenerative joint disease (NID): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia. - · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. - · Those patients with failed previous surgery where pain, deformity, or dysfunction persists. - Revision of a previously failed hip arthroplasty. - · Patients who require a total hip replacement.

The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The +10.5mm offset option for the Femoral Head Adapter Sleeves is a line extension to the currently available predicate adapter head offsets (K100445). The subject device is fabricated from Ti6Al4V per ASTM F136. The subject device is compatible with 32mm and 36mm BIOLOX® OPTION Ceramic Femoral Heads (K143407), and also compatible with the Klassic HD® Femoral Stems (K100445) and the Klassic Blade Femoral Stems (K151440 and K171962). The subject components are provided sterile, for single use, by prescription only.

The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia. · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. - · Those patients with failed previous surgery where pain, deformity, or dysfunction persists. · Revision of a previously failed hip arthroplasty. · Patients who require a total hip replacement.

The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add BIOLOX CONTOURA® Ceramic Femoral Heads in diameters of 28mm, and 36mm, in various head offsets.

The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: - · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia. - · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. - · Those patients with failed previous surgery where pain, deformity, or dysfunction persists. - · Revision of a previously failed hip arthroplasty. - · Patients who require a total hip replacement.

The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add larger sizes of the Klassic® Blade Femoral Stems and add a new material for previously cleared Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems.

The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia. - · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. - · Those patients with failed previous surgery where pain, deformity or dysfunction persists. - · Revision of a previously failed hip arthroplasty. - · Patients who require a total hip replacement.

The Total Joint Orthopedics Klassic HD® Acetabular Insert with XLPE ("Insert with XLPE") is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with XLPE is fully compatible for use with the previously cleared Klassic HD® Hip System and is manufactured from UHMWPE crosslinked by gamma irradiation. The Insert with XLPE is sterilized by ethylene oxide gas and intended for single-use only.

The Klassic HD™ Hip System is intended for prosthetic replacement without bone cement in treatment of the following: - . Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia. - Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. ● - Those patients with failed previous surgery where pain, deformity, or dysfunction ● persists. - Revision of a previously failed hip arthroplasty. - Patients who require a total hip replacement.

The Klassic HD™ Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum, leg length, offset and version. The Klassic HD™ Hip System can be mated with metal (CoCrMo) or ceramic femoral heads and UHMWPE acetabular components.