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510(k) Data Aggregation
(85 days)
888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
MBH
888.3560
The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.
The patient's needs for knee replacement should be due to one or more of the following conditions:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis
- Inflammatory degenerative joint disease including rheumatoid arthritis
- Functional deformity such as varus, valgus or flexion deformities
- Revision procedures where other treatments or device have failed
- Fractures that are unmanageable using other techniques
Signature Orthopaedics' World Knee/Active-V Knee replacement components may be intended for cemented or cementless use.
Active-V Total Knee System
The Active-V Total Knee is a modular total knee system consisting of a femoral component, a meniscal insert, a patella, tibial baseplate with a fin keel and an external tibial augment. The femoral and tibial components are intended for cemented and cementless use. The tibial insert bearing components are available in cruciate retaining (CR) and ultracongruent (UC) variants while the femoral components are available in posterior stabilizing (PS) and CR variants. All components are intended for single use only.
The femoral component is an anatomically accurate designed prosthesis manufactured from cast cobalt chrome (CoCrMo) alloy. The tibial component is a modular symmetrical tray design, manufactured from Ti6Al4V Alloy. Cementless femoral components with plasma sprayed commercially pure titanium and hydroxyapatite coating with the option of titanium nitride coating are included. Tibial components with the same coating specifications as the femoral components are available. The tibial external augment is manufactured from the same Ti6Al4V alloy. The meniscal insert is available in CR and Medialconstrained (MC) variant surfaces, and is manufactured from Vitamin-E stabilized UHMWPE (HXLPE). The patella is a spherical, 3-peg patella design manufactured from Vitamin-E stabilized UHMWPE. Components are available for cemented or cementless use.
World Total Knee System - Line Extension
The World Knee line extension presented in this 510(k) is addition of the following components:
- Cementless femoral components with new coating specifications (plasma sprayed commercially pure titanium and hydroxyapatite coating with the option of titanium nitride coating)
- Tibial components with the modified coating specifications (same as the femoral components) and tibial tray to fin keel modular design
- Constrained condylar knee (CCK) variant of the all poly tibia component and meniscal insert, and medialconstrained (MC) variant of the meniscal insert
- Tibial external augment
The femoral component is an anatomically accurate designed prosthesis manufactured from cast cobalt chrome (CoCrMo) alloy. The tibial component is a modular symmetrical tray design, manufactured from Ti6Al4V Alloy. The tibial external augment is manufactured from the same Ti6Al4V alloy. The meniscal inserts and all poly tibia are manufactured from conventional Ultrahigh Molecular Weight Polyethylene (UHMWPE) and Vitamin E Stabilized and 100 kGy Crosslinked UHMWPE (Vit-E HXLPE). Components are available for cemented or cementless use.
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(93 days)
, Texas 78758
Re: K252974
Trade/Device Name: EMPOWR Knee
Regulation Number: 21 CFR 888.3560
joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
Regulation: 21 CFR 888.3560
When a mechanical alignment approach is utilized, these devices are indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis;
- avascular necrosis of the femoral condyle;
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- moderate valgus, varus or flexion deformities;
- treatment of fractures that are unmanageable using other techniques.
These devices may also be indicated in the salvage of previously failed surgical attempts.
When the EMPOWR® Dynamic Natural Alignment (DNA) approach is utilized, these devices are indicated for patients with disability due to:
- degenerative, post-traumatic or rheumatoid arthritis;
- avascular necrosis of the femoral condyle;
- moderate valgus, varus or flexion deformities.
All EMPOWR devices except for the EMPOWR Revision Knee™, EMPOWR PS Knee™, and EMPOWR Partial Knee™ may be implanted using the EMPOWR® Dynamic Natural Alignment (DNA) surgical technique.
All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella which are intended for cementless applications.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Enovis™ knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
The purpose of this submission is to obtain clearance for the EMPOWR® Dynamic Natural Alignment (DNA) surgical technique. The proposed technique is a kinematic alignment (KA) strategy, providing an alternative alignment approach to the current mechanical alignment (MA) strategy. The purpose of the KA technique is to restore normal knee function by preserving the patient's native joint line. The technique may be used to implant all EMPOWR devices except for the EMPOWR Revision Knee™ and the EMPOWR PS Knee™. This is a labeling change only. No design changes are being introduced to the implant systems.
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(84 days)
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| Associated Product Code(s) / Classification: | JWH 21 CFR 888.3560: Knee joint patellofemorotibial
porous-coated uncemented prosthesis. |
| Associated Product Code(s) / Classification: | JWH 21 CFR 888.3560
Balanced Knee® System TriMax® Porous Femoral Components are intended for single use uncemented or cemented total knee arthroplasty with the following indications:
- Loss of joint configuration and joint function.
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint.
- Post-traumatic arthritis of the knee joint.
- Valgus, varus, or flexion deformities of the knee joint.
- Revision procedures where other treatments or devices have failed.
Balanced Knee® System TriMax® Porous Femoral Components are intended for use as part of total knee arthroplasty (TKA) procedures. Total knee arthroplasty is a procedure where worn, diseased, or damaged surfaces of the knee joint are removed and replaced with artificial surfaces.
The components are prescription products consisting of single use devices for implanting into patients in an operating room by a qualified surgeon.
Balanced Knee® System TriMax® Porous Femoral Components are a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component with Co-Cr-Mo sintered porous coating.
The device will have two configurations:
- Cruciate Retaining (CR) Femoral – (Substantially Equivalent to K152169)
- Posterior Stabilized (PS) Femoral – (Substantially Equivalent to K123457)
They have the same materials of constructions and the same articular geometry as the legally marketed TriMax cemented femoral components. The new feature is the addition of the CoCr porous coating on the bone contacting surfaces that is substantially equivalent to the reference device: Maxx Orthopedics Freedom Porous Femoral Component (K150680).
Balanced Knee® System TriMax® Porous Femoral Components are manufactured from cast Co-Cr-Mo per ASTM F75.
The subject device has a variety of sizes to accommodate variations in patient anatomies: left and right orientations, medial-lateral width (56 – 79.5mm), anterior-posterior width (50 – 74mm), and CR & PS variations.
Balanced Knee® System TriMax® Porous Femoral Components are compatible with BKS® High Flex PS Tibial Inserts (K123457, K131337), BKS® High Flex Patellar Button (K131337), BKS® TriMax® CR and US Tibial Inserts (K152169), and BKS® TriMax® PS Plus Tibial Inserts (K233093).
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(95 days)
- Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (21 CFR §888.3560
• 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.
• Revision of previous unsuccessful knee replacement or other procedure.
Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s):
• There is destruction of the joint surfaces, with or without significant bone deformity.
• The cruciate and/or collateral ligaments do not stabilize the knee joint.
• The ligaments are inadequate and/or the musculature is weak. And/or
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.
When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.
When used with compatible GMRS components:
• Where segmental resection and/or replacement of femur and/or proximal tibia is required.
• 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 stabilized by standard fracture management techniques.
• 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 stabilized by standard fracture management techniques.
The Triathlon Tritanium Tibial Baseplate and Tritanium Metal-Backed Patella components are indicated for both uncemented and cemented use.
The devices covered by this Traditional 510(k) Premarket Notification are Stryker UHMWPE devices (including knee patella devices and hinged knee bumper) that are packaged in a N2Vac environment. The packaging for these devices consists of an impermeable foil pouch in a Polyethylene Terephthalate Glycol (PETG) blister sealed with a Tyvek lid. All subject devices are commercially available and have been found to be substantially equivalent in previous 510(k)s.
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(54 days)
ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors
Regulation Number: 21 CFR 888.3560
| Common or usual name | Total Knee Replacement Prothesis |
| Classification name | 21 CFR 888.3560
Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3560
, 21 CFR 888.3565, 21 CFR 888.3560 |
| Product Code(s) | JWH: Prosthesis, Knee, Patellofemorotibial
| Common or usual name | Total Knee Replacement Prosthesis |
| Classification name | 21 CFR 888.3560
ATTUNE™ Total Knee System
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors
The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:
- malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
- revision cases for a failed previous prosthesis requiring extensive resection and replacement;
- severe trauma requiring extensive resection and replacement.
The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.
The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only.
The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.
A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component consists of a metal tibial base without porous coating, and a locking polyethylene insert. Some metal components have modular stems, porous and non porous-coated sleeves and/or modular augments. The patella component is an all polyethylene design.
The ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors are designed as a component in the replacement of the natural articular surface of the knee joint or of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The ATTUNE Revision Sleeve LPS Femoral Adaptors are to be used to connect an ATTUNE Revision Femoral Sleeve to LPS System Components.
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(29 days)
K253314**
Trade/Device Name: Freedom Infinia™ Total Knee System
Regulation Number: 21 CFR 888.3560
The Freedom Infinia™ Total Knee System is indicated for the following:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities.
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods.
- Revision surgery where sufficient bone stock and soft tissue integrity are present. (For PCK Components and Primary PCK Components only)
The Freedom Infinia™ Total Knee System components are intended for cemented and single use only. The Freedom Infinia™ Cementless Femoral (CR and PS) Components and Porous Tibial Base Plates are additionally indicated for cementless biological fixation application.
The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. The Freedom® Total Knee System was originally cleared under the 510(k) number K082019. Later on, several modifications were made and were cleared under 510(k)s K090411, K091280, K111785, K131481, K150680, K182574, K192148, K241597, K243277, K251717 respectively.
This submission seeks the clearance of an additional brand, Freedom Infinia™ Total Knee System.
Below is the description of the Freedom Infinia™ Total Knee System's components.
Freedom Infinia™ Femoral Component
The Freedom Infinia™ Total Knee System's Femoral Component is offered in both cruciate retaining and posterior stabilizing designs. The Femoral components are available in right and left configurations, and eight sizes to accommodate varying anatomy. The Freedom Infinia™ Total Knee System's Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application to replace the articulating surface of the distal femur in a measured resection.
Freedom Infinia™ Cementless Femoral Component
The Freedom Infinia™ Total Knee System's Cementless Femoral Component is offered in both cruciate retaining and posterior stabilizing designs. The Cementless Femoral Components are available in right and left configurations, and eight sizes to accommodate varying anatomy. The Freedom Infinia™ Total Knee System's Cementless Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and porous coated CoCr beads and is intended for cementless biological fixation application to replace the articulating surface of the distal femur in a measured resection.
Freedom Infinia™ Stemmed Femoral Component
The Freedom Infinia™ Total Knee System's Stemmed Femoral Component with progressive constraint (PCK) is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75, intended for cemented application to replace the articulating surface of the distal femur in a measured resection technique. It is available in left and right configurations. Each configuration is further available in 8 different sizes (A to H) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions. Thus total of 16 models are available for the Stemmed Femoral Component.
Freedom Infinia™ Femoral Augments
The Freedom Infinia™ Total Knee System's Femoral Augments are fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136. These augments are intended to be screwed to the internal distal and posterior surfaces of Freedom Infinia™ PCK Stemmed Femoral Component when required in cases of significant bone loss. The augments are designed to be stackable and for use on either the medial or lateral side.
Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, are available as an accessory to the system to fix the augments to the Freedom Infinia™ Stemmed Femoral Component and other augments.
The Freedom Infinia™ Femoral Augments is available in distal and posterior design configuration. Each configuration is further available in 6 different sizes.
Freedom Infinia™ Primary PCK Femoral Component
Freedom Infinia™ Total Knee System's Primary PCK Femoral Component is designed to be used with the Freedom Infinia™ Stemmed Tibial Components. It is fabricated from Cobalt- Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application.
Freedom Infinia™ Tibial Base Plate
The Freedom Infinia™ Total Knee System's Tibial Base Plate is fabricated from Cobalt- Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.
Freedom Infinia™ Titanium Tibial Base Plate
The Freedom Infinia™ Total Knee System's Titanium Tibial Base Plate is fabricated from Wrought Titanium alloy Ti-6Al-4V ELI, compliant with ASTM F136-13 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Titanium Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.
Freedom Infinia™ Porous Tibial Base Plate
The Freedom Infinia™ Total Knee System's Porous Tibial Base Plate is intended for use with existing, compatible Femoral Components and Tibial Liner Components. Freedom Infinia™ Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom Infinia™ Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.
Freedom Infinia™ Stemmed Tibial Base Plate
The Freedom Infinia™ Total Knee System's Stemmed Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Stemmed Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions and are supplied with UHMWPE plugs to close off augment screw holes and distal taper when not used and with a set screw to provide additional locking to the stem or offset junction during extraction.
Freedom Infinia™ Tibial Augments
The Freedom Infinia™ Total Knee System's Tibial Augments are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136. These augments are intended to be screwed to the distal surface Freedom Infinia™ Stemmed Tibial Base Plate when required in cases of significant bone loss. The augments are designed to be stackable, using a system of pins, bosses and screws, and reversible for use on either the medial or lateral side. Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, are available as an accessory to the system to fix the augments to the Stemmed Tibial Base Plate and other augments.
Freedom Infinia™ Stem Extension
The Freedom Infinia™ Total Knee System's Stem Extensions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136. The Freedom Infinia™ Stem Extensions are intended for use with Freedom Infinia™ Stemmed Tibial Base Plate. The Freedom Infinia™ Stem Extensions are available in a range of diameters and lengths and are fluted distally with a distal slot in the larger lengths and diameters.
Freedom Infinia™ Offset Junction
The Freedom Infinia™ Total Knee System's Offset Junctions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, are intended to be used with the Freedom Infinia™ Stemmed Tibial Base Plate to provide an additional 4mm or 6mm offset between the tibial keel and stem. Freedom Infinia™ The Offset Junction is attached to the tibial component and stem through taper junctions. A set-screw is supplied with the Offset Junction to provide additional locking during extraction.
Freedom Infinia™ Tibial Liner
The Freedom Infinia™ Total Knee System's Tibial Liner is available in two designs i.e. posterior stabilizing (PS) and cruciate retaining (CR). Based on the Tibial Liner compatibility with Femoral Component configurations, each PS and CR designs are available various sizes with different anterior/posterior (A/P) and medial/lateral (L/P) dimensions, and each size is further bifurcated as on thickness. Tibial liner is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) complying with ASTM F648 and is intended for cemented application along Tibial Base Plate to replace the articulating surface of the proximal tibia in a measured resection. Both the CR and PS Tibial Liners have identical locking mechanisms to mate with the Tibial Base Plate.
Freedom Infinia™ Medial Congruent Liner
The Freedom Infinia™ Total Knee System's Medial Congruent Liners have been developed with the desire to achieve a higher level of constraint than typically achieved in a traditional CR knee design while also providing the femoral component with a medial-pivoting motion throughout a range of motion. They possess an anterior and buildup and a higher sagittal conformity of the medial compartment that interact with the femoral component, to provide additional constraint. Designed to be used with the CR Femoral Component. Eliminates the need to remove bone for a PS box. Designed to allow high flexion. Includes a deep anterior patellar cut- out to allow for tendon clearance. Facilitates intraoperative flexibility, given compatibility with existing femoral and tibial baseplate options.
Freedom Infinia™ Ultra-Congruent CR Tibial Liner
The Freedom Infinia™ Total Knee System's Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner complies with ASTM F648 that is designed to be used with the Freedom Infinia™ Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom Infinia™ Total Knee System.
Freedom Infinia™ PCK Tibial Liner
The Freedom Infinia™ Total Knee System's PCK Tibial Liner is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) complies with ASTM F648. Based on the Tibial liner compatibility with PCK femoral component configurations, each PCK tibial liner design is available different sizes with different anterior/posterior (A/P) and medial/lateral (L/P) dimensions, and each size is further bifurcated on thickness variants.
The PCK Tibial Liners consist of the same articulating surface of existing Tibial liner components and have a same locking mechanism on the peripheral edge of the distal surface to lock into the Tibial / Stemmed Tibial Base Plate. The PCK tibial liner supplied with a liner securing pin manufactured from Ti-6Al-4V ELI to provide additional locking with stemmed tibial base plate.
Freedom Infinia™ All Poly Tibial Component
The Freedom Infinia™ Total Knee System's All Poly Tibial Component is fabricated from ultra high molecular weight polyethylene (UHMWPE) complying with ASTM F648 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection. Both the Total Knee System CR and PS Tibial Inserts have identical locking mechanisms to mate with the Tibial Base Plate.
Freedom Infinia™ All Poly Patella
The Freedom Infinia™ Total Knee System's All Poly Patella is available in symmetrical single radius design. Based on different diameter and thickness different models are available. All Poly Patella is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) complying with ASTM F648.
The symmetric design features a central cement recess, and three pegs on the bone interface surface. The symmetric patellar component is intended for cemented application via an onset resurfacing surgical technique.
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(116 days)
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Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (21 CFR 888.3560
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 stabilized by standard fracture-management techniques
The Triathlon® Gold Femoral Components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System is a total knee prosthesis designed to resurface the articulating surface of the femoral and tibial bones. In a total knee replacement, Triathlon® Gold Femoral Components are intended to replace the articulating surface of the distal femur and articulate against an articular surface of the tibial component as well as an optional patellar component. Triathlon® Gold Femoral Components are additively manufactured from Ti-6Al-4V powder, using Electron Beam Melting (EBM) technology, and then fully coated with titanium nitride (TiN), using Physical Vapor Deposition (PVD). In addition to TiN coating, the bone cut facing surfaces of these femoral components contain the Tritanium® porous structure. Indicated for both uncemented and cemented use, the subject femoral components are provided in right and left configurations and eight proportional sizes (sizes 1-8) for a total of 16 unique components to accommodate differences in patient anatomy. The subject femoral components are sterile, single use devices.
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(27 days)
Trade/Device Name:** Freedom® Total Knee System - Titan PCK Components
Regulation Number: 21 CFR 888.3560
The Freedom® Total Knee System is indicated for patients with severe knee pain and the disability due to:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities.
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods.
- Revision surgery where sufficient bone stock and soft tissue integrity are present. (For PCK Components and Primary PCK Components only)
The Freedom® Total Knee System – Titan PCK Components are intended for cemented and single use only.
The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. The Freedom® Total Knee System was originally cleared under the 510(k) number K082019. Later on, several modifications were made and were cleared under 510(k)s K091280, K192148, K090411, K182574, K131481, K111785, K200912, and K240863 respectively.
This submission seeks the clearance of Titanium Niobium Nitride (TiNbN) coated version of previously cleared Femoral Augment (non-coated version cleared in K131481), Tibial Augments, Stem Extension & Offset Junction (non-coated versions cleared in K111785). The coated versions are now branded as Freedom® Total Knee System – Titan PCK Components.
Below is the description of the coated components.
Freedom® Titan Femoral Augments
The Freedom® Titan Femoral Augments are fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). These augments are intended to be screwed to the internal distal and posterior surfaces of the previously cleared PCK Stemmed Femoral Component (K131481) and Titan PCK Stemmed Femoral Component (K240863) when required in cases of significant bone loss. The augments are designed to be stackable and for use on either the medial or lateral side.
Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN), are available as an accessory to the system to fix the augments to the Stemmed Femoral Component and other augments.
The Freedom® Titan Femoral Augments is available in distal and posterior design configuration. Each configuration is further available in 6 different sizes.
Freedom® Titan Tibial Augments
The Freedom® Titan Tibial Augments are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). These augments are intended to be screwed to the distal surface of the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863) when required in cases of significant bone loss. The augments are designed to be stackable, using a system of pins, bosses and screws, and reversible for use on either the medial or lateral side.
Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN), are available as an accessory to the system to fix the augments to the Stemmed Tibial Base Plate and other augments.
Freedom® Titan Offset Junction
The Freedom® Titan Offset Junctions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). Offset Junctions are intended to be used with the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863) to provide an additional 4mm or 6mm offset between the tibial keel and stem. The Offset Junction is attached to the tibial component and stem through taper junctions. A set-screw is supplied with the Offset Junction to provide additional locking during extraction.
Freedom® Titan Stem Extension
The Freedom® Titan Stem Extensions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). The Titan Stem Extensions are intended for use with the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863). The Stem Extensions are available in a range of diameters and lengths and are fluted distally with a distal slot in the larger lengths and diameters.
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(28 days)
/Device Name:** Stem Extension Line (U2 Total Knee System-PSA Type)
Regulation Number: 21 CFR 888.3560
patellofemorotibial polymer/ metal/ polymer semiconstrained cemented prosthesis |
| Regulation Number | 888.3560
This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
Note: In the US, this device is for cemented use only.
"UNITED" U2 Total Knee System – Posterior Stabilized Augmentable (PSA) type is a patellofemorotibial polymer/ metal/ polymer, semiconstrained, cemented knee prosthesis, which has a metallic femoral component and a tibial component composed of a polyethylene insert and a metallic tibial baseplate. Tibial inserts are available in two design configurations: for the PSA type insert, it is intended for use in patients who require constrained stabilization of the tibiofemoral joint due to soft tissue imbalance. While the PSA low constrained type (PSA, LC) insert provides less constrained stabilization than the PSA type insert.
This system is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock. There are a variety of components including femoral augment set, tibial augment, stem extension and offset stem adapter that provide more choices for surgeon to treat their patients. In addition, this system provides more stability for patients with inadequate medial-lateral, anterior-posterior or varus-valgus soft tissue imbalance. For total knee replacement, "UNITED" patella components are intended to be used with the U2 Total Knee System—PSA Type.
For the subject device, it's a line extension of the 510(K) cleared device U2 Total Knee System—PSA Type (K082424), which introduces the variation, Straight Stem, Cross Slot, PSA, with stem lengths from 75mm to 200mm, diameters from Ø10 to Ø24mm.
The compatibility of the Straight Stem, Cross Slot, PSA is the same as that of the 510(k) cleared U2 Total Knee System—PSA Type (K082424).
The Straight Stem, Cross Slot, PSA is an extension of the geometric characteristics of the 510(k) cleared device, U2 Total Knee System—PSAType (K082424). Its materials, size, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Straight Stem, PSA.
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(247 days)
joint femorotibial metal/polymer constrained cemented prosthesis |
| Regulation Number | 888.3565, 888.3560
U2 Total Knee System - PF+ is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Femoral Component, PF+, Tibial Baseplate, PF+, Tibial Extension Stem, Patella, Onset, E-XPE, PF+, and Patella, Asymmetric Onset, E-XPE, PF+ are indicated for both cemented and cementless use.
USTAR II Total Knee System
- Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
- Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
- Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
- Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
- Joint instability resulting from excessive bone resection.
For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.
For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and intended for cementless use only.
The subject PF+ Patella is a line extension of the U2 Total Knee System, and is compatible to the USTAR II System. The subject device, U2 Total Knee System–PF+ Patella; USTAR II System - PF+ Patella, is a Metal-Backed Patella, indicated for both cemented or cementless application. There are two variations available: (1) Patella, Onset, E-XPE, PF+, and (2) Patella, Asymmetric Onset, E-XPE, PF+. Patella, Onset, E-XPE, PF+ is a symmetric, dome-type metal-backed patella, and Patella, Asymmetric Onset, E-XPE, PF+ is an asymmetric, anatomic-type patella. Each type is available in five sizes. The body of PF+ patella is manufactured from Vitamin E blended highly cross-linked UHMWPE (ASTM F2695, ASTM F648/ISO5834-1), while the part of the metal back and the three pegs are produced by additive manufacturing according to the FDA guidance "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff", "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", and "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post market Surveillance Requirements." The metal back is made of Ti-6Al-4V alloy (ASTM 2924) and has a porous Ti structure on the bone side, peg side, and poly side. All types of PF+ Patella are compatibility with "United" U2 Total Knee System-Femoral components (K051640, K120507, K140073, K140075, K150829, and K150832), Femoral component, PSA (K082424), Femoral components, PF+ (K221705), and USTAR II System-Femoral components (K190100).
The provided text is a 510(k) Clearance Letter from the FDA for a total knee system. It details the device's name, regulation, a summary of its description, intended use, and a comparison to predicate devices, along with a list of non-clinical tests conducted.
However, the document specifically states "No clinical data is necessary." This means that the clearance was not based on a clinical study demonstrating the device's performance against detailed acceptance criteria in human patients with the format typically requested in your prompt (e.g., sensitivity, specificity, human-in-the-loop performance, ground truth establishment by experts, etc.).
Instead, the clearance is based on the substantial equivalence of the new device to existing legally marketed predicate devices, primarily through non-clinical testing and technological comparison.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from a clinical study, as no such study was presented or required for this 510(k) clearance.
The "acceptance criteria" for this device, as implied by the FDA clearance, revolve around demonstrating that its technological characteristics and non-clinical performance are substantially equivalent to already cleared devices.
Here's what I can extract from the document regarding the non-clinical tests that functionally served as part of the "proof" that the device meets some form of performance criteria:
Summary of Non-Clinical Tests (Implicit Acceptance Criteria & Performance):
| Test Conducted | Purpose (Implicit Acceptance Criteria) | Reported Performance |
|---|---|---|
| Pull-out test | To demonstrate adequate mechanical fixation strength, particularly for the patella's pegs and porous coating intended for cementless or cemented application. The implicit acceptance criterion would be that the pull-out strength meets or exceeds established industry standards or predicate device performance for similar implants, ensuring secure attachment in the bone. | (Details of results not provided in the 510(k) letter, but implied to be acceptable to FDA.) |
| Characterization of Ti porous coating | To ensure the porous Ti structure meets specifications for biocompatibility, porosity, and surface characteristics conducive to bone ingrowth and secure fixation. Acceptance criteria would involve adherence to specified material standards (e.g., ASTM 2924 for Ti-6Al-4V alloy) and potentially specific measurements of pore size, interconnectivity, and coating thickness, as referenced by the FDA guidance documents listed. | (Details of results not provided, but implied to be acceptable to FDA.) |
| Durability test | To assess the long-term mechanical integrity and resistance to wear and fatigue of the patella components (e.g., UHMWPE and metal back) under simulated physiological loading conditions. The acceptance criterion would be that the device maintains its structural integrity and functional performance over a clinically relevant lifespan, comparable to or exceeding predicate devices. | (Details of results not provided, but implied to be acceptable to FDA.) |
| Usability evaluation | To evaluate the ease of use, safety, and effectiveness of the device's design, particularly for the surgical implantation process. This might involve simulated use by surgeons or assessment of design features that minimize surgical errors. The acceptance criterion would be that the device can be safely and effectively implanted without undue difficulty or risk. | (Details of results not provided, but implied to be acceptable to FDA.) |
| Endotoxin testing | To ensure the device is free from harmful levels of bacterial endotoxins, which can cause adverse patient reactions if present. The acceptance criterion is typically a low or undetectable level of endotoxins, meeting pharmacopeial standards for medical devices. | (Details of results not provided, but implied to be acceptable to FDA.) |
Since no clinical study was conducted or referenced in this 510(k) clearance documentation, the following points of your request cannot be addressed from the provided text:
- Sample size used for the test set and data provenance: Not applicable, as no clinical test set was used. The non-clinical tests were performed on device prototypes or samples.
- Number of experts used to establish the ground truth... / qualifications of those experts: Not applicable. Ground truth for clinical performance was not established.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards and methodologies (e.g., ASTM standards for material properties, mechanical testing protocols).
- The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In essence, this 510(k) clearance is a regulatory determination of substantial equivalence based on non-clinical performance data and technological comparisons to predicate devices, not on a clinical trial demonstrating performance against specific diagnostic or treatment outcome acceptance criteria in humans.
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