(135 days)
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 need 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 devices have failed.
- . Fractures that are unmanageable using other techniques.
Signature Orthopaedics' World Knee replacement components may be intended for cemented or cementless use. Please verify whether the particular component is intended for cementless use by checking the package label.
The World Knee system is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate or all polyethylene tibia. The femoral component and tibial baseplate components are manufactured from cast cobalt chromium alloy and are intended for use with or without bone cement. The cementless variants are additionally coated with cobalt chromium beads and hydroxyapatite. The cemented femoral components are also available as a symmetrical variant. The femoral component may be used with modular pegs. The modular femoral peg is manufactured from wrought cobalt chromium allov. The femoral component, meniscal inserts and all polyethylene tibias are available as postererior stabilized or cruciate retaining variants.
Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the all polyethylene tibia, meniscal insert and patella are manufactured from UHMWPE. The patella components are available in a spherical or non-symmetrical designs.
The provided text describes the regulatory clearance of the "World Total Knee System" by Signature Orthopaedics. This document is a 510(k) premarket notification letter from the FDA, and it focuses on demonstrating substantial equivalence to previously cleared predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study or standalone performance testing in the way an AI/software device would.
Therefore, the requested information components (1, 2, 3, 4, 5, 6, 7, 8, 9) regarding acceptance criteria, sample sizes, ground truth establishment, expert validation, and MRMC studies are not applicable to this type of device clearance document.
Instead, the document details:
-
Non-clinical testing and engineering evaluations were conducted to verify performance. These included:
- Range of motion analysis
- Component contact area and stress testing
- Porous coating characterization, shear strength, tensile strength, and shear fatigue testing
-
The company claims substantial equivalence to several predicate devices based on:
- Same intended use and indications for use.
- Similar materials (cast cobalt chromium alloy, UHMWPE, hydroxyapatite, wrought cobalt chromium alloy).
- Similar geometry for specific components (e.g., Symmetrical World Knee femur to Total Joint Orthopedics Klassic Knee System, World Knee All Poly Tibia to Smith & Nephew Genesis II Knee System's All Poly Tibia, World Knee patellas to Signature Orthopaedics World Knee System, Signature Orthopaedics Genius Knee System, and Smith & Nephew Genesis II Knee System's patellas).
In summary, this document is for a medical device (knee prosthesis) seeking 510(k) clearance, which relies on demonstrating substantial equivalence through non-clinical performance and material comparisons, not typically through clinical trials with acceptance criteria, ground truth, or expert review like a digital health or AI-driven device would.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.