G3A 40 Bone Cement

• K Number: K181282
• Device Name: G3A 40 Bone Cement
• Manufacturer: G21 S.r.l
• Date Cleared: 2019-01-09 ( 239 days)
• Product Code: LOD , MBB
• Regulation Number: 888.3027
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a bone cement device (G3A 40 Bone Cement). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of details are typically found in the 510(k) summary or the full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information based on the text provided.

Regulation Number and Section

§ 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.”