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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 prostheses designed to help surgeons restore hip joint biomechanics. The purpose of this 510(k) is to add the Platform Acetabular System consisting of the Platform Acetabular Shell with Ti-Coat and Platform Acetabular Inserts with E-Link (Neutral and Hooded) to the Klassic HD Hip System. The Platform Acetabular Shells are fabricated from Ti6Al4V per ASTM F136 and the Platform Acetabular Inserts with E-Link are made from Vitamin E. UHMWPE material. The subject acetabular components are available in various sizes ranging in outer diameters of 44mm to 64mm to match patient anatomy and are compatible with 28mm, 32mm, and 36mm heads. The subject components are provided sterile, for single use, by prescription only.

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™, and the Klassic Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.

The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts and Ultra-PS® Tibial Inserts, which are fabricated with E^X Poly, to the Klassic® Knee System. E^X Poly is a crosslinked UHMWPE containing alpha-tocopherol. The subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts are available in various sizes and thicknesses to match patient anatomy.

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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

The Klassic® Femur with Aurum®, is being introduced as a line extension for use with the Klassic® Knee System for cemented implantation during total knee arthroplasty. The Klassic® Femur with Aurum® is manufactured from Titanium alloy (Ti6Al4V per ASTM F136) with a titanium nitride surface.

The Klassic® Knee System is intended for prosthetic replacement 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® Knee System is indicated for cemented use only, except for the Klassic® Femur with Cobalt 3D®, and the Klassic® Tibial Baseplate with Ti-Coat® which are indicated for cementless use.

The purpose of this Special 510(k) is to add the Klassic® Tibial Inserts, PS-Max®, an additional posterior stabilizing design option, to the Klassic® Knee System (K112906). The Klassic® Tibial Inserts, PS-Max® are available in various sizes and thicknesses to match patient anatomy and provide surgical options.

The Klassic® Knee System is intended for prosthetic replacement 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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

The Klassic® Knee System employs prostheses designed to help surgeons restore knee joint biomechanics intra-operatively. The purpose of this 510(k) is to add the posterior stabilizing Klassic® Knee Femur, PS-Post; Klassic Femoral Pegs; and the Klassic® Tibial Insert, PS-Post with Standard Poly; and the Klassic® Tibial Insert, PS-Post with E-Link® Poly; to the Klassic Knee System. The subject femoral and tibial components are available in various sizes and thicknesses to match patient anatomy.

The Klassic Knee 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 Knee System is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®. which are indicated for cementless use.

The purpose of this 510(k) is to add size 5, 10mm Sombrero Patella components in Standard Poly and E-Link Poly to be used in conjunction with the Klassic® Knee System during total knee replacement. The components are manufactured from ultrahigh molecular weight polyethylene or Vitamin E blended ultrahigh molecular weight polyethylene with a 40mm diameter and 10mm thickness.

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 (NIDJ): 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 smaller sizes of the Acetabular Cups, Acetabular Inserts, and Ceramic Femoral Heads and to add both smaller and predicate sizes of Hooded and Low Profile Acetabular Inserts with XLPE material.

The Klassic® Knee System is intended for prosthetic replacement in treatment of the following: - Patient conditions of non-inflammatory degenerative joint disease (NIDJ): . 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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts with E-Link®, Ultra-PS® Tibial Inserts with E-Link®, Sombrero Patellae with E-Link® and Domed Patellae with E-Link® ("E-Link® Knee Components") to the Klassic® Knee System. These components are manufactured from E-link®, a Vitamin E blended UHMWPE crosslinked by gamma irradiation. The E-Link® Knee Components are available in various sizes and thicknesses to match patient anatomy.

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 Total Joint Orthopedics Klassic HD® Hooded Acetabular Insert with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly are permanently implanted devices for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The subject inserts are fully compatible for use with the previously cleared Klassic HD® Hip System and are manufactured from UHMWPE crosslinked by gamma irradiation and infused with vitamin E. The subject inserts are sterilized by ethylene oxide gas and intended for single-use only.

The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement 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® Knee System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to add All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to the Klassic Knee System. These components are manufactured with ultrahigh molecular weight polyethylene (UHMWPE). The CR/Congruent and Ultra-PS® A11-Poly Tibias are available in sizes to match various patient anatomies.