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General total knee arthroplasty indications include: • Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis - · Post-traumatic loss of knee ioint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament. The ACS® LD FB Knee System is intended for cemented use, single use only. The ACS® LD FB Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The ACS® LD FB Knee System is a modular knee replacement system offering various components that can be combined to replace the knee joint with various options depending upon the size and anatomy of each patient. The ACS® LD FB Knee System consists of: - . ACS® LD Femoral Components - o ACS® LD Femoral Component - o ACS® LD Femoral Component Slim - o ACS® LD PS Femoral Component Slim - o ACS® LD PS Femoral Component - o ACS® LD SC Femoral Component - ACS® LD FB+ Tibial Components ● - o ACS® LD FB+ Tibia - o Locking Plug for ACS® FB Tibial Component - o Cone Plug for ACS® FB Tibial Component - ACS® FB+ PE-Inserts ● - o ACS® FB+ PE-Insert - ACS® FB+ PE-Insert Hyperflex o - ACS® FB+ PE-Insert Ultra o - o ACS® FB+ PS PE-Insert Hyperflex - o ACS® FB+ SC PE-Insert - ACS® Double Taper - ACS® Stem ● - o ACS® LD Extension Stem Male Taper - o ACS® Stem - ACS® Spacers . - o ACS® FB Tibial Spacer - o ACS® FB screw for spacer - o MK Femoral Spacer - o MK Screw for Spacer - ACS® Patella Replacements - o ACS® PE-Patella The ACS® LD FB Knee System is available as a non-coated (LD) fixed bearing (FB) version. The tibial and femoral components are available in cemented version.

The EcoFit® hip stems are intended to be used in total hip arthroplasty for the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - Rheumatoid arthritis; - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and - Revision of previously failed total hip arthroplasty. The EcoFit® hip stems are intended for uncemented, press-fit fixation. The EcoFit® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head System for the following indications: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The purpose of this Traditional 510(k) is to expand the EcoFit® Hip System with a line extension to the existing EcoFit® short stems cementless cpTi. The new EcoFit® short stems cementless cpTi are available in two different sizes 16.25 mm and in both standard and lateralized offset versions. The new EcoFit® short stems cementless cpTi included in the subject 510(k) are intermediate sizes, as compared to the EcoFit® short stems cementless cpTi predicate devices

The EcoFit®, implaFit® and BethaLoc® hip stems are indicated for use in cases of: · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - · Rheumatoid arthritis; · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and · Revision of previously failed total hip arthroplasty. The EcoFit®, implaFit® and BethaLoc® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications: · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - · Correction of functional deformity · Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. The EcoFit® hip stems, the implaFit® hip stems cementless and the BethaLoc® hip stems are intended for uncemented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation. The ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the BethaLoc® hip stems and EcoFit® Hip System for the following indications: · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - · Correction of functional deformity · Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the BethaLoc® hip stems. The BethaLoc® hip stems are femoral stems for total or hemi hip arthroplasty. The BethaLoc® hip stems are available in standard and lateralized offset configurations. The BethaLoc® hip stems are monoblock, tapered straight stems made from titanium alloy with a partial coating of hydroxyapatite (HA). They are fixed by press-fitting. The BethaLoc® hip stems are intended to be used with previously cleared EcoFit® Hip components.

The ACS® LD Uni FB Knee System is indicated 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. This device is single-use implant intended for implantation with bone cement.

The ACS® LD Uni FB Knee System is a unicondylar knee replacement system. It is intended for patients with unicompartmental osteoarthritis and intact cruciate and collateral ligaments. The ACS® LD Uni FB Knee System consists of the following components: - ACS® Uni LD Femoral Component . - Uni FB Tibial Component ● - Uni FB PE-Insert ●

The AGILON® XO Shoulder Replacement System is indicated for use for cementless inverse (reverse) total or hemi shoulder replacement in cases of: - Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, . - . Post-traumatic osteoarthritis. - Fractures, - . Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: - Multifragmental comminuted fractures of the humeral head, - 3- and 4-Fragment-fractures of the proximal humerus, - . Head-splitting fractures, - . Dislocated head-splitting fractures, - . Humeral head depression with more than 40% of joint surface depressed, - . Interlocking chronic dislocation with deep HILL-SACHS lesion, - . Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening), - Posttraumatic humeral head necrosis, ● - . Omarthrosis. AGLON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: - . Rotator cuff tear arthropathy, - . Chronic trauma shoulder, - . Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows: - From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty ● - . From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty - From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure ● - . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined into an hemi or reverse shoulder: Hemi Shoulder: - Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap) ● - o Humeral Stems (Cementless) Reverse Shoulder: - Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ● - o Glenoid and Glenosphere Components (AGLION® XO Glenoid Baseplate and AGILON® Glenosphere) - o Humeral Stems (Cementless) Metaphyseal components, stem extension pieces, and component connection fixation screws are intended to be used for hemi and reverse shoulder configurations.

The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur System is intended to for uncemented use in total hip arthroplasty for the following indications: - Proximal femur replacement in oncology cases where radical resection and replacement of bone is required. - Limb salvage procedures including surgical intervention failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required. Use of this prosthesis is generally only indicated in skeletally mature patients

The MUTARS® Proximal Femur Replacement System is a modular hip replacement system, which combines the offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur Replacement System includes the MUTARS® Proximal Femur System. The MUTARS® Proximal Femur System is manufactured of TiAls V4 and includes the proximal femur, femoral stem, stem extension piece, connecting part, and screws. The MUTARS® Proximal Femur Replacement System can be used as a total hip system with previously cleared (K163577) modular cobalt chrome femoral head, Ecofit® uncemented titanium alloy acetabular cup and polyethylene liner.

The EcoFit® Hip System is indicated for use as a total hip replacement in cases of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - · Rheumatoid arthritis; · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and - Revision of previously failed total hip arthroplasty. The EcoFit® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.

The EcoFit® Vit E Acetabular System is a line extension of EcoFit® Hip System, a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The EcoFit® Vit E Acetabular System adds additional liners, CoCr femoral heads, and Biolox® delta heads to the currently cleared system. Additionally, Vit E liners are added as compatible components in the system.

The EcoFit® Hip System is indicated for use as a total hip replacement in cases of: - · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - Rheumatoid arthritis; · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and · Revision of previously failed total hip arthroplasty The EcoFit® Hip Stem and EcoFit® Acetabular Cup are intended for uncemented, press-fit fixation.

The EcoFit® Hip System consists of EcoFit® femoral hip stems, modular Cobalt Chrome Molybdenum alloy femoral heads, and modular metal backed acetabular cups with ultra-high molecular weight polyethylene liners. The EcoFit® femoral stem system includes three versions: the standard length stem and a Coxa Vara version. The EcoFit® femoral hip stem is collarless, straight, monoblock, flat tapered wedge design manufactured from TiAlsV4 alloy. The stem tapers from proximal to distal and is designed with a rectangular cross sectional geometry to provide rotational stability. A plasma sprayed coating of commercially pure titanium (cpTi) is applied to the proximal half of the stem. The modular femoral heads are manufactured from Cobalt Chrome Molybdenum alloy and attach to the femoral stem via a Morse style taper in a diameter of 32 mm in several neck lengths. The EcoFit® Acetabular Cup is a two (2) piece modular cup consisting of a metal shell and a polyethylene liner. The metal shell is manufactured from TiAlsV4 alloy and a plasma sprayed coating of commercially pure titanium (cpTi) is applied to the metal shell. The polyethylene liner is manufactured from ultra-high molecular weight polyethylene and is available with an inner diameter of 32 mm for use with 32 mm outer diameter femoral head. The metal shell has a threaded insertion hole at the apex and the shell is available in two (2) versions, one with three (3) peripheral holes for the placement of bone screws as needed for adjunctive fixation and one without screw holes. A threaded apex hole plug is provided to fill the threaded insertion hole after shell placement while bone screw hole plugs are available to fill screw holes that are not used. The EcoFit® hip stems and EcoFit® acetabular cups are intended for uncemented press-fit application.