(76 days)
The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:
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;
Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
Ligamentous instability requiring implant bearing surfaces with increased constraint;
Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement, with the exception of porous coated femoral components which can be used cemented or uncemented (biological fixation).
The Arthrex iBalance® TKA System consists of femoral components, tibial tray, tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components are available in left and right versions and are designed to work with the Arthrex dome patella components. Femoral and tibial tray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibial bearing and patellar components are manufactured from UHMWPE conforming to ASTM F-648.
The Arthrex iBalance® BioSync™ Femoral Components line offers the option of affixing the system's femoral components without cement through the use of a titanium scaffold porous coating (biological fixation).
The provided document is a 510(k) premarket notification for a medical device, the Arthrex iBalance® TKA System. It does not describe an AI/ML powered device, therefore, the requested information about acceptance criteria and the study proving the device meets those criteria, particularly as it relates to AI/ML performance metrics, is not present.
The document discusses the substantial equivalence of the Arthrex iBalance® TKA System to legally marketed predicate devices, focusing on design features, intended uses, materials, and mechanical testing.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving performance for an AI-powered device, as this document pertains to a traditional orthopedic implant.
The document details the following for the Arthrex iBalance® TKA System:
- Device Description: A total knee arthroplasty system consisting of femoral components, tibial tray, tibial bearing components, and patellar components. The BioSync™ Femoral Components line extension offers the option of uncemented fixation through a titanium scaffold porous coating.
- Intended Use/Indications for Use: For individuals undergoing surgery for painful, disabling joint disease of the knee (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of knee joint configuration and function, moderate varus, valgus, or flexion deformity, and revisions of previous unsuccessful knee replacement. Additional indications for posteriorly stabilized components include ligamentous instability and absent or non-functioning posterior cruciate ligament.
- Substantial Equivalence Summary: The device is considered substantially equivalent to the predicate device (K081127: Accin™ Total Knee System and K121771: Zimmer® Persona™ Personalized Knee System). Differences are considered minor and don't raise questions concerning safety and effectiveness.
- Testing Information: Fatigue, biocompatibility, metallurgical, corrosion, microstructure, strength, bonding, abrasion, and ingrowth testing information was submitted to demonstrate consistency with FDA Guidance for porous-coated orthopedic implants.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.