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K Number
K162618
Device Name
CONCORD Plus Radiopaque Bone Cement
Manufacturer
GLOBUS MEDICAL, INC.
Date Cleared
2017-01-23

(125 days)

Product Code
NDN
Regulation Number
888.3027
Type
Traditional
Panel
OR
Reference & Predicate Devices
K042168,K091606
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CONCORD Plus™ Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Description

The CONCORD Plus™ Radiopaque Bone Cement is a high-viscosity, radiopaque, self-curing, PMMA bone cement. It is provided sterile, as a two component system, a liquid component and a powder component which are mixed together prior to use to form the cement. The bone cement is intended for single use only.

AI/ML Overview

I am sorry, but based on the provided text, there is no information available regarding an AI device, its acceptance criteria, or a study proving it meets those criteria.

The document is a 510(k) premarket notification for a medical device called "CONCORD Plus™ Radiopaque Bone Cement." This is a physical bone cement, not an AI or software-as-a-medical-device.

Therefore, I cannot provide the requested information in the table format or answer the questions related to AI device performance, sample sizes, ground truth establishment, or expert reviews. The text discusses the bone cement's physical and chemical properties, sterilization methods, and comparison to predicate devices, all of which are irrelevant to AI device evaluation.

§ 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.”