(107 days)
Refobacin® Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.
Refobacin® Bone Cement R is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, produces a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive in the liquid component serves as optical marking of the bone cement at the site of the operation.
This document describes a 510(k) premarket notification for the "Refobacin Bone Cement R" and does not contain information about an AI/ML powered device. As such, I cannot extract information related to acceptance criteria, study plans, or ground truth for an AI-based system.
The document pertains to a medical device in the field of orthopedics, specifically bone cement used in arthroplasty procedures. The submission focuses on demonstrating substantial equivalence to a predicate device (Palacos® G Bone Cement) based on non-clinical testing of mechanical, chemical, physical, and handling characteristics. Clinical data was explicitly not required for this determination of substantial equivalence.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”