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510(k) Data Aggregation
(39 days)
888.3560) |
| Additional product codes | OIY (21 CFR 888.3560)OOG (21 CFR 888.3560)MBH (21 CFR 888.3565
product code | JWH (21 CFR 888.3560)OIY(21 CFR 888.3560)OOG (21 CFR 888.3560)MBH (21 CFR 888.3565
Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.
Hardware
• Pin Placement Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting.
The Materialise TKA Guides must be used in conjunction with the Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Zimmer Persona® OsseoTi® Keel Tibia, Zimmer Persona® Cemented Keel Tibia, Zimmer Persona® PPS® Femur, Vanguard® Complete Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.
The Materialise TKA Guides are intended for single use only.
• Cut-Through Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting and cutting of the bone.
The Materialise TKA Guides must be used in conjunction with the Vanguard® Complete Knee System, prostheses families only.
The Materialise TKA Guides are intended for single use only.
• Models
The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components.
The Materialise TKA Models must be used in conjunction with Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Zimmer Persona® OsseoTi® Keel Tibia, Zimmer Persona® Cemented Keel Tibia, Zimmer Persona® PPS® Femur, Vanguard® Complete Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.
The Materialise TKA Models are intended for single use only.
Software
The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise TKA Guides and Models.
The Materialise TKA Guide System is a medical device designed to be used to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a presurgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery.
The subject device is a system that consists of the following two functional components:
• A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a personalized pre-surgical TKA plan according to either a mechanical or a restricted kinematic alignment philosophy based on patient anatomy. This initial plan can then be further edited by the surgeon.
• Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).
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(85 days)
/Device Name:** Active-V Total Knee System; World Total Knee System
Regulation Number: 21 CFR 888.3565
(2) 9428 5181
Fax: +61 (2) 8456 6065
Date Prepared: 22nd December 2025
Classification: 888.3565
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)
patellofemorotibial metal/polymer porous-coated uncemented prosthesis
Regulation: 21 CFR 888.3560, 21 CFR 888.3565
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)
Device Name:** Balanced Knee System TriMax Porous Femoral Components
Regulation Number: 21 CFR 888.3565
Device Name:** Balanced Knee System TriMax Porous Femoral Components
Regulation Number: 21 CFR 888.3565
sintered porous coated knee femoral prosthesis) |
| Product Code / Classification: | MBH 21 CFR 888.3565
sintered porous coated knee femoral prosthesis) |
| Product Code / Classification: | MBH 21 CFR 888.3565
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)
888.3560)
- Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (21 CFR §888.3565
• 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)
– Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis 21 CFR 888.3565
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3560, 21 CFR 888.3565
– Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis 21 CFR 888.3565
| Classification panel | 87 Orthopedics |
| Regulation | Class II - 21 CFR 888.3560, 21 CFR 888.3565
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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(59 days)
Device Name:** Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
Regulation Number: 21 CFR 888.3565
Regulation Number: 888.3565
Product Code(s): MBH, JWH
Legally Marketed Predicate Devices
The Freedom® 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, and Metaphyseal Cones only).
The Freedom Porous Tibial Base Plate, and Cementless Femoral Components, and Metaphyseal Cones are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.
The Freedom Metaphyseal Cones are additionally indicated for use in addressing tibial bone voids and/or metaphyseal reconstruction.
The subject device, Freedom Knee Metaphyseal Cone implants, is a component addition to the cleared Freedom Total Knee System for addressing tibial bone voids and/or metaphyseal reconstruction. The Freedom Knee Metaphyseal Cone implants are designed with an elliptical shape, scaling larger in the Medial-Lateral (ML) direction than the Anterior-Posterior (AP) direction. The sizes are driven by the ML size, ranging from 25mm to 60mm wide in the ML direction and 29mm to 36mm AP in the AP direction. The cones are all 30mm long and feature a stepped design to further enhance the stability in the proximal-distal direction.
The Freedom Knee Metaphyseal Cone implants feature a large internal diameter to accept the largest possible Freedom Knee Stemmed Tibial Baseplate and Stem Extension possible. The internal diameters grow larger with each implant size, and all feature cement pockets to enhance the stability of the eventual TKA construct. The cone implants also feature 12mm wide relief slots to accept the fins/keel of the Freedom Knee Tibial Baseplate.
The AP and ML sides of the cone implants (which contact the metaphyseal bone) feature a 1mm thick proprietary scaffold structure. This structure, only possible via the additive manufacturing process, is designed to mimic the size and porosity of cancellous bone. The implant is comprised of Ti6Al4V ELI metal certified to ASTM F3001 and is manufactured with significant surface roughness to further add to the hydrophilic nature of the implant.
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(116 days)
- Triathlon® Total Knee System - Triathlon® Gold Femoral Components
Regulation Number: 21 CFR 888.3565
Classification Name:** Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (21 CFR 888.3565
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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(247 days)
** U2 Total Knee System - PF+ Patella; USTAR II System- PF+ Patella
Regulation Number: 21 CFR 888.3565
prosthesisKnee joint femorotibial metal/polymer constrained cemented prosthesis |
| Regulation Number | 888.3565
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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(54 days)
888.3560) |
| Additional product codes | OIY (21 CFR 888.3560)OOG (21 CFR 888.3560)MBH (21 CFR 888.3565
Decision date** | July 5, 2022 |
| Classification product code | JWH (21 CFR 888.3560)MBH (21 CFR 888.3565
Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.
Hardware
• Pin Placement Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting.
The Materialise TKA Guides must be used in conjunction with the Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.
The Materialise TKA Guides are intended for single use only.
• Cut-Through Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting and cutting of the bone.
The Materialise TKA Guides must be used in conjunction with the Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System and AGC® Complete Knee system prostheses families only
The Materialise TKA Guides are intended for single use only.
• Models
The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components.
The Materialise TKA Models must be used in conjunction with Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.
The Materialise TKA Models are intended for single use only.
Software
The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.
The Materialise TKA Guide System is a medical device designed to be used to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a presurgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery.
The subject device is a system that consists of the following two functional components:
• A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a personalized pre-surgical TKA plan according to either a mechanical or a restricted kinematic alignment philosophy based on patient anatomy. This initial plan can then be further edited by the surgeon.
• Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and to guide cutting of the bone. The patient-specific models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).
The provided FDA 510(k) clearance letter and summary for the Materialise TKA Guide System describes the device and its indications for use, but it does not contain the specific acceptance criteria or the details of a study (like a clinical study or specific performance data) that proves the device meets those criteria.
Instead, the document primarily focuses on establishing "substantial equivalence" to a predicate device (Materialise TKA Guide System K221337) and a reference device (Materialise PKA Guide System K202207). It states that "The non-clinical performance testing indicates that the subject device is as safe and effective as the predicate device." However, it does not provide the actual results of this non-clinical performance testing in terms of specific acceptance criteria and detailed study outcomes.
The information given is typical for a 510(k) summary, which generally affirms that V&V (Verification and Validation) was done and that the device performs as intended, but it doesn't usually include the granular details of the V&V studies themselves, especially not in a public-facing clearance letter. These details would be contained within the full 510(k) submission, which is not publicly accessible in its entirety.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide answers to most of your specific questions (sample size, data provenance, expert details, adjudication, MRMC study, ground truth type, training set details) because this information is not present in the provided text.
The document mentions:
- Software verification and validation: "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements, and validation against user needs." This implies acceptance criteria were defined (as "defined requirements" and "user needs") and met, but the specific metrics and results are not listed.
- Hardware testing: "Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device (no changes have been applied to the Hardware)." Again, this confirms testing occurred and was successful, but the specific criteria and outcomes are omitted.
In summary, none of the specific data you requested (acceptance criteria, study details, sample sizes, expert qualifications, etc.) are available in the provided FDA 510(k) clearance letter.
To provide the information you're looking for, one would typically need access to the full 510(k) submission, specifically the V&V reports, which are proprietary and not released with the public clearance letter.
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