(27 days)
DePuy CMW 1 Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
DePuy 1 Gentamicin Bone Cement is a self-curing cement. The cement allows the seating and securing of a metal or plastic prosthesis to living bone. The following modifications are being made:
- . DePuy CMW 1 Gentamicin will be made available in a 20 gram presentation in addition to the previously cleared 40 gram presentation.
- . Changes are being made to the formulation of the bone cement liquid component.
The provided text is a 510(k) premarket notification for a medical device (DePuy CMW 1 Gentamicin Bone Cement). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.
Instead, it focuses on:
- Device Description: General information about the bone cement and modifications being made (new 20g presentation and changes to liquid component formulation).
- Intended Use and Indications: Specifies its use in the second stage of a two-stage revision for total joint arthroplasty after infection clearance.
- Basis of Substantial Equivalence: States that the device is considered substantially equivalent to previously cleared/approved bone cements based on similarities in formulations, manufacturing methods, and intended use.
- FDA Correspondence: Letters confirming the 510(k) clearance and related regulatory information.
Therefore, I cannot provide the requested table and information as there is no data in the provided text to fulfill those requirements.
The document is a regulatory submission for a bone cement, not a study evaluating its diagnostic performance or clinical effectiveness with specific metrics. It states the intent to market based on substantial equivalence to existing devices, implying that the safety and effectiveness are inferred from those predicate devices, rather than demonstrated through a de novo clinical study with specific acceptance criteria.
§ 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.”