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General Total Knee Arthroplasty (TKR) Indications: • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. · Post-traumatic loss of knee joint configuration and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Revision of previous unsuccessful knee replacement or other procedure. - Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques. The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use. The Triathlon® Total Knee System beaded with Peri-Apatite components are intended for uncemented use only. The Triathlon® All Polyethylene tibial components are indicated for cemented use only. Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components: - · Ligamentous instability requiring implant bearing surface geometries with increased constraint. - · Absent or non-functioning posterior cruciate ligament. · Severe anteroposterior instability of the knee joint. Additional Indications for Total Stabilizer (TS) Components: · Severe instability of the knee secondary to compromised collateral ligament integrity or function. Indications for Bone Augments: · Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatic arthritis, complicated by the presence of bone loss. · Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. Additional Indications for Cone Augments: - · Severe degeneration or trauma requiring extensive resection and replacement - · Femoral and Tibial bone voids - Metaphyseal reconstruction The Triathlon TS Cone Augment components are intended for cemented or cementless use. Triathlon Pro Posterior Stabilized Femoral Components Indications for Use: General Total Knee Arthroplasty (TKR) Indications: · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. - · Post-traumatic loss of knee joint configuration and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Revision of previous unsuccessful knee replacement or other procedure. · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques. Additional Indications for Posterior Stabilized (PS) components: - · Ligamentous instability requiring implant bearing surface geometries with increased constraint. - · Absent or non-functioning posterior cruciate ligament. - · Severe anteroposterior instability of the knee joint. The Triathlon® Pro PS Femoral Components are intended for cemented use only. Triathlon Tritanium Tibial Baseplate Indications for Use: General Total Knee Arthroplasty (TKR) Indications: · Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis - · Post-traumatic loss of knee joint configuration and function - · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability - · Revision of previous unsuccessful knee replacement or other procedure - · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant: - · Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament - · Severe anteroposterior instability of the knee joint The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use. Triathlon Low Profile Tibial Tray Indications for Use: The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below: Indications for Use: · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. · Post-traumatic loss of knee joint configuration and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Triathlon Metal Backed Patella Indications for Use: - · Noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis; - Rheumatoid arthritis; - · Correction of functional deformity; - · Revision procedures where other treatments or devices have failed; - · Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, - · Irreparable fracture of the knee. These products are intended to achieve fixation without the use of bone cement. Triathlon Partial Knee System Indications for Use: Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis · Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis · Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau. These components are intended for implantation with bone cement. Avon Patello-femoral Joint Prosthesis Indications for Use: 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 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. Restoris Multi-Compartmental Knee System Indications for Use: Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include: - Medial unicondylar - Lateral unicondylar - Patellofemoral - · Medial bi-compartmental (medial unicondylar and patellofemoral) Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.

All of the subject devices have been found substantially equivalent in previous 510(k)s. All the subject devices have been cleared for MR conditional labeling in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified. An additional contraindication is being added to the components of the Triathlon Total Knee System. This contraindication regarding material sensitivity to implant materials is being added.

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.

1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device. Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed: and 4. Treatment of fractures that are unmanageable using other techniques Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement. 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices. 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Journey II Total Knee system components are indicated for use only with cement and are single use devices. Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed; and 4. Treatment of fractures that are unmanageable using other techniques Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement. Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis: · Correction of functional deformity; · Revision procedures where other treatments or devices have failed; and · Treatment of fractures that are unmanageable using other techniques. Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Journey II Total Knee system components are indicated for use only with cement and are single use devices. 1. Degenerative arthritis in the distal femur and patella; 2. A history of patellar dislocation or patellar fracture; and 3. Failed previous surgery (arthroplasty, tibial tubercule elevation, lateral release) where pain, deformity or dysfunction persists. The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement. Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed; and 4. Treatment of fractures that are unmanageable using other techniques Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement. 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent. 6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent. The Legion Hinge Knee System is for Cemented Use Only. 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent. 6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent. The LEGION Knee System - Finned Tibial Wedges are for single use only and are intended for implantation with bone cement. These devices are indicated for patients with: 1. Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. 2. Previous tibial condyle or plateu fractures with loss of anatomy or function. 3. Varus or Valgus deformities. 4. Revision of previous arthroplasty procedures. The devices are indicated for cemented use only. The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis. - Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty - As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis. The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used. Total Knee components are indicated for: 1. Rheumatoid arthritis 2. Post- traumatic arthritis, osteoarthritis, or degenerative arthritis 3. Failed osteotomies, unicompartmental replacement, or total knee replacement 4. The posterior stabilized knee system is designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices. The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

The purpose of this Traditional 510(k) is to add MR safety information to the labeling (instructions for use, product labeling and patient implant card) of the subject Smith & Nephew Knee Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. As these products have been in distribution for several years, some parts have undergone changes in the technological characteristics that were assessed in compliance with the FDA's guidanceon "Deciding When to Submit a 510(k) for a Change to an Existing Device" or the FDA predecessor guidance on how to review changes to an existing device. These are not cumulative changes for all Smith & Nephew Knee Systems, but are rather specific changes that only affect certain parts. In the context of this submission, no modifications have been made to the device design, materials, sterilization, or the manufacturing process of the previously cleared devices due to the addition of MR Labeling for this 510(k).

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.

RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include: - · Medial unicondylar - · Lateral unicondylar - · Patellofemoral - · Medial bi-compartmental (medial unicondylar and patellofemoral) RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity. There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices. The subject implant components are identical to the predicate components. The Restoris MCK system was most recently cleared in K180612, and has also been cleared previously in K172326, K150307, K090763, K082172, K082088, K082081, and K080368.

The MOTO™ Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one compartment of the joint is affected due to the compartmental primary degenerative or posttraumatic decenerative disease, previous tibial condule or plateau fractures, deformity or revious arthroplasty. 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, 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™ Partial Knee & MOTO™ PFJ Systems is a line extension to provide a larger product offering. The subject devices are sterile implantable devices designed for cemented use in partial knee arthroplasty procedures. The MOTO™ Partial Knee & MOTO™ PFJ Systems extension includes: - Medial femoral components TiNbN coated, left medial, sizes from 1 to 10; ● - Lateral femoral components TiNbN coated, sizes from 1 to 7; ● - Medial tibial inserts fixed E-cross, left medial and right medial, sizes from 1 to 8 and 6 thicknesses ● from 8 to 14; - . Lateral tibial inserts fixed E-cross, sizes from 1 to 8 and 6 thicknesses from 8 to 14; - . Patello Femoral Joint TiNbN coated, left and right, sizes from 1 to 6; - MOTO Patella E-cross, 6 sizes. ● The subject femoral components, as well as the patello femoral joint, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4 with Titanium Nitride (TiNbN) coating. The subject tibial inserts, as well as the MOTO patella, are made of E-Cross (Vitamin-E Highly Crosslinked UHMWPE).

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.

· Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis · Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis · Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau. These components are intended for implantation with bone cement.

The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E) are unchanged since the last premarket notification for the devices in K180612. The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are unchanged since the last premarket notification for the devices in K172326. The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E), Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are collectively referred to throughout this submission as the subject devices. The purpose of this "Change Being Effected" premarket notification is to add a contraindication for the Triathlon® PKR X3® Tibial Inserts, Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate. Additionally, minor clarifications are being made to the labeling.

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.