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The Overture Orthopaedics Patellofemoral System is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The Overture Orthopaedics Patellofemoral System is comprised of trochlear implants, and a set of ancillary instruments. The trochlear implants are titanium and feature a polished articulating surface with a titanium nitride (TiN) coating. The patellar implants are cross-linked ultra high molecular weight polyethylene (UHMWPE) and feature a titanium pin for X-ray visualization. The trochlear and patellar implants utilize cemented pegs for immediate fixation. The trochlear implants also feature porous titanium bone-contacting surfaces. The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. The trochlear implants are offered in long and round geometries. The long implants are offered in lengths ranging 25-40mm and widths ranging 20-35mm. The round trochlear implants are offered in diameters ranging 20-35mm. The patellar implants are offered in a domed geometry in diameters of 25mm and 30mm. The implants are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and are to be sterilized by the end user.

The Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists. The device is intended for cemented fixation.

The Episealer Patellofemoral System is a patient-individualized arthroplasty device which replaces a damaged patellofemoral joint. The subject device consists of two components: - . Episealer PF - Patellar Component ● The Episealer PF component is implanted centrally in the trochlear area of the distal femur. The Patellar Component is implanted on the backside of the patella and articulates with the Episealer PF.

The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

This submission covers the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. The femoral components are manufactured from Cobalt Chrome (CoCr) and the patellar components are manufactured from Ultra-high Molecular Weight Polyethylene (UHMWPE) materials. The purpose of this submission is to add Magnetic Resonance (MR) Conditional labeling to the labeling of the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. Additionally, minor labeling and packaging updates, as detailed in the respective sections, are also included in this submission.

The MOTO PFJ is designed for cemented use in partial knee arthroplasty, if there is evidence of enough sound bone to seat and support the components. Patellofemoral replacement is indicated in the following cases: Osteoarthritis, post-traumatic arthritis, polyarthritis, severe chondrocalcinosis of the patellofemoral joint. Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, cartilage transplantation). History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral joint. Degeneration induced by dysplasia. If the surgeon evaluates an unequivocal indication for replacement of the patellofemoral joint, with or without a patella resurfacing, which outweighs the risks associated with the surgery, PFJ replacement may be considered, particularly for young patients.

The MOTO PFJ System, subject of this submission, consists of: - o Patello Femoral Joint, made of Cobalt-Chromium-Molybdenum alloy - MOTO Patella, made of UHMWPE ● The MOTO PFJ System is intended for replacement of the femoral trochlea of the patellafemoral joint affected by injury and/or disease process. The MOTO PFJ System is intended for cemented use only. The MOTO PFJ System may be used alone or in combination with the MOTO Partial Knee System Unicompartmental Prosthesis (Medial K161741 and Lateral K183029) and GMK UNI Prosthesis (K162084), to treat multiple conditions of patellofemoral and tibiofemoral regions of the natural knee. The Patello Femoral Joint component is designed to articulate with natural patella or with the dedicated MOTO Patella.

Intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The Patello-Femoral Wave《hung Arthroplasty System is a line extension to the Sponsor's previously cleared and commercially marketed HemiCAP™ Patello-Femoral Resurfacing System. The line extension consists of a larger femoral component for increased coverage of the trochlear groove. The additional sizes will address larger defects of the superior aspect of the trochlea and provide greater coverage superiorly. The system also includes larger mating UHMWPE patella components as described within. The larger PF Kahuna trochlear Patello-Femoral Wave"«ከ«ባ articular component is designed to mate with the currently marketed Arthrosurface Patello-Femoral fixation component. The majority of the implantation technique steps are the same. The PF Kahuna trochlear component is implanted using the same Instrumentation Set as with the HemiCAP™ Patello-Femoral Resurfacing System, with the addition of a reaming operation to create the superior ream. The reamers, associated implant trials etc. are contained within an adjunct Patello-Femoral WaveKahuna Instrumentation Kit.

When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multi-compartmental knee arthroplasty in patients with: - Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; - Correction of functional deformities; - Revision of previous unsuccessful partial knee replacement or other procedure; The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee. These components are single use only and are intended for implantation with bone cement

The Arthrex iBalance BiCompartmental Arthroplasty System is comprised of a unicompartmental implant system (Arthrex iBalance UKA) and a patellofemoral implant system (Arthrex iBalance PFJ). The Arthrex iBalance UKA and Arthrex iBalance PFJ systems may be used in conjunction to create a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee.

The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patellofemoral arthroplplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

The patella components are to be used with the existing Prelude PF Knee Resurfacing System. The components manufactured from polyethylene (UHMWPE) conforming to ASTM F-648 with a stainless steel x-ray wire and consist of larger sized patella options.

The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patella-femoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

The Prelude™ Patellofemoral (PF) Resurfacing Knee System is a patellofemoral resurfacing prosthesis incorporating a distal femoral trochlear surface articular component and a patella component. The cast femoral component is manufactured from CoCrMo (ASTM F-75) and the MIM femoral component is manufactured from CoCrMo (ASTM F-2886) both with a porous undersurface coating of titanium from polyethylene (UHMWPE) conforming to ASTM F-648 with a stainless steel x-ray wire. The implant system is intended to be implanted with bone cement.

The replacement of the patellofemoral joint with the KNEETEC PFJ device is indicated in the case of symptoms and serious signs affecting daily activities involving the joint: - Serious degenerative arthritis of the patellofemoral joint, - Failure of conservative procedures (realignment, arthroscopy, transfer of the tibial tuberosity) with the persistence of joint pain or dysfunction, - Patellofemoral dislocation (dysplastic or other origin), - Post-traumatic arthritis (patellar fracture), The KNEETEC PFJ patellofemoral prosthesis is intended for cemented use only. When used in association with the KNEETEC PFJ prosthesis, the patellar component of the HLS KNEETEC has the above mentioned indications for use.

The Kneetee PFJ is a semiconstrained resecting prosthesis intended for replacement of the patellofemoral joint. The prosthesis consists of two components, both for cemented use only: a femoral implant and a patella. The patella of the knee joint may be resurfaced with the HLS KNEETEC patellar component and a substantially equivalent in K094013) or KNEETEC PFJ patellar implant.

The MAKO Surgical Corp. Patellofemoral Knee Implant System II is intended to be used in cemented patello-femoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

This device consists of a CoCrMo patellofemoral component and an ultra-high molecular weight polyethylene patella components are intended for cemented, one-time use only. The anterior surface of the patellofemoral component is polished and features a trochlear groove. The posterior surface of the patellofemoral and patella component employ features such as cement pockets and pegs for enhanced stability of the prosthesis when cemented onto the femur and patella, respectively.