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Polymethylmethacrylate (PMMA) Bone Cement Class II

Polymethylmethacrylate (PMMA) Bone Cement Class II

CFR - Code of Federal Regulations Title 21

Apr 01, 2020  Class II (special controls). The special control for this device is the FDA guidance document entitled "Class II Special Controls Guidance Document:

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21 CFR § 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

Jul 17, 2002  Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document:

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Medical devices; reclassification of ...

The Food and Drug Administration (FDA) is announcing that it has reclassified the polymethylmethacrylate (PMMA) bone cement intended for use in arthroplastic

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21 CFR § 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

Jul 17, 2002  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.” [ 67 FR 46855 , July 17, 2002]

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DEPARTMENT OF HEALTH HUMAN SERVICES Public

Trade/Device Name: VertaPlex® High Viscosity (HV) Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, LOD Dated: May 15, 2015 Received: May 18, 2015 Dear Ms. Ashton:

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August 30, 2018 Vexim SA Ms. Janice Hogan Regulation Name ...

Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement . Regulatory Class: II . Product Codes: NDN, Cement, Bone, Vertebroplasty . III. PREDICATE DEVICE. Primary Predicate Kiva® VCF Treatment System, K132817 . Reference Device StaXx™ FX System, K053336 . Reference Device/Clinical Comparator Kyphon KyphX Xpander® Inflatable Bone

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21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

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.” [67 FR 46855, July 17, 2002]

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Manjusha Bharadwaj Regulatory/Quality Consultant RQMIS ...

Classification Name: Polymethylmethacrylate (PMMA) bone cement, antibiotic Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulation Number: 21 CFR 888.3027, 21 CFR 888.3560 Regulatory Class: Class II Product codes MBB, JWH . III. PREDICATE DEVICES

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JUL 12004 *Dezov

Polymethyl Methacrylate (PMMA) and styrene co-polymer bone cement with Antibiotic. CLASSIFICATION: Class II; 21 CFR 888.3027 DEVICE PRODUCT CODE: LOD SUBSTANTIALLY EQUIVALENT DEVICE: DePuy I Gentamicin Bone Cement (K023103), SmartSet GMV Endurance Gentamicin Bone Cement (K033382) and SmartSet GHV Gentamicin Bone Cement (K033563)

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510(k) Summary SmartSet GHV Gentamicin Bone Cement

Nov 10, 2003  Trade/Device Name: SmartSet GHV Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: November 10, 2003

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21 CFR § 888.3027 Polymethylmethacrylate (PMMA) bone ...

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.” [67 FR 46855, July 17, 2002] ©

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Class II Special Controls Documents FDA

This page lists special controls guidance and guideline documents developed by CDRH and CBER. Devices classified into class II are devices for which special controls, combined with general ...

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Laboratory confirmed polymethyl-methacrylate (Palacos ...

Dec 01, 2010  Polymethyl-methacrylate (PMMA) as part of bone cement is a widely used material in the context of orthopaedic implants and also in cranioplasty. Although PMMA is characterised by excellent biocompatibility with low intrinsic toxicity and inflammatory activation, a minor portion of patients develop allergic reactions.

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Medical devices; reclassification of ...

The Food and Drug Administration (FDA) is announcing that it has reclassified the polymethylmethacrylate (PMMA) bone cement 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 from class III to class II (special controls).

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Ageing and moisture uptake in polymethyl methacrylate ...

employs polymethyl methacrylate (PMMA) bone cement to secure the prosthesis to the bone and distribute stresses ... (Case I) and non-Fickian (Case II and anom-alous) and can be related by M t¼kt n, where M t is the amount of solvent absorbed per unit area at time t, k is a constant and n is a parameter related to the diffusion mechanism which

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Perceptions of Polymethyl Methacrylate Cement Exposure ...

on of exposed mucous membranes. The purpose of this study is to investigate the perceptions of PMMA cement exposure during pregnancy in female orthopaedic surgeons because it influences (1) the currently held beliefs and practices and (2) clinical and career choices. Methods: A 23-question survey was distributed via e-mail to all active members of the Ruth Jackson Orthopaedic Society and the ...

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eCFR :: 21 CFR Part 888 -- Orthopedic Devices

The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.” [ 67 FR 46855 , July 17, 2002] § 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

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eCFR :: 21 CFR Part 888 -- Orthopedic Devices

The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.” [ 67 FR 46855 , July 17, 2002] § 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

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A Method for Cemented Bone Interface Examination Without ...

However, the PMMA process can take more than 22 d and dissolves the bone cement, seriously cornpromising quantitative bone–cement interface analyses. A simplified method for processing mineralized bones with cemented implants in preparation fox SEM analysis could prove to be beneficial in assessing the durability of cemented fixation in bone.

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Bone Cement Failure - Class Action

Bone cement may also be inserted directly into the bone to help repair microfractures and bone loss. Calcium-based bone cement is used to mimic lost bone. The most common type of bone cement is polymethyl methacrylate (PMMA) —the same chemical that makes p lexiglass. There are multiple types of bone cement.

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A bioactive polymethylmethacrylate bone cement for ...

High viscosity PMMA bone cement, SmartSet®HV (DePuy, Blackpool, UK), with a 2.6:1 ratio (w/v) of the powder phase and the liquid phase was mixed manually to obtain a uniform flowing phase in a teflon container. Then 15 wt% MC particles were added into the PMMA bone cement, according to our previous work . Thus, the PMMA-MC bone cement ...

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Bone cement, polymethylmethacrylate bone cement

Apr 18, 2013  Bone cement commonly known polymethyl methacrylate or PMMA, is widely used for implant fixation in various orthopaedic and trauma surgery for over 50 years. In reality, “cement” is a misnomer because, the word cement is used to describe a substance that bonds two things together.

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Biocompatibility of particulate polymethylmethacrylate ...

The volume of polymethyl methacrylate (PMMA) bone cement shrank by 3.82%–7.08% during solidification. Such volume shrinkage generated a residual stress that induces minor cracking in bone–cement interface and affected the long-term stability and mechanical property of vertebral body.

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Poly(methyl methacrylate) bone cement composited with ...

Jan 16, 2020  Then, the bone cement (PMMA bone cement or PMMA bone cement modified with MC) and the MMA monomer liquid were mixed evenly until the viscous wire-drawing stage, and the mixture was then injected. The starting time of injection was recorded, and the whole process of injecting the cement was monitored by C-arm fluoroscopy, ensuring that the bone ...

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Poly(methyl methacrylate) - Wikipedia

Poly (methyl methacrylate) (PMMA), also known as acrylic, acrylic glass, perspex, or plexiglass, as well as by the trade names and brands Crylux, Plexiglas, Acrylite, Astariglas, Lucite, Perclax, and Perspex, among several others (), is a transparent thermoplastic often used in sheet form as a lightweight or shatter-resistant alternative to glass.It can also be used as a casting resin, in inks ...

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Perceptions of Polymethyl Methacrylate Cement Exposure ...

Mar 02, 2020  Therefore, in brief, PMMA is a colorless, volatile liquid with distinct odor, high vapor pressure (4 kPa at 20°C), and moderate water solubility (15.8 g/L). The purity of commercial methyl methacrylate is typically 99.9%. 1, 7 PMMA vapor released into the air is broken down by exposure to hydroxyl radicals and ozone. 8 The reported half-life ...

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Clinical Trial Considerations: Vertebral Augmentation ...

used in spinal vertebral body augmentation include polymethylmethacrylate (PMMA) based bone cements, classified under 21 CFR 888.3027, class II (special controls). FDA has

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The characteristics of a hydroxyapatite-chitosan-PMMA bone ...

In this study, we propose a new bioactive bone cement (BBC), composed of natural bone powder (hydroxyapatite; HA), chitosan powder, and the currently available polymethylmethacrylate (PMMA) bone cement, for use in orthopedic surgeries such as vertebroplasty or as bone

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Bone Cement Implantation Syndrome

As early as 1958, bone cement solely for the purpose for orthopaedic surgery was developed to perform specific functions such as: Affix the prosthesis Fastening of implant to bone Delivery device for antibiotics locally (3,5) Polymethylmethacrylate (PMMA) is a type of bone cement commonly used for clinical applications in orhtopaedic surgery.

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Comprehensive biocompatibility testing of a new PMMA-hA ...

Jan 01, 2003  For more than 50 years PMMA bone cements have been used in orthopaedic surgery. In this study attempts were made to show whether cultured human bone marrow cells (HBMC) show an osteogenetic response resulting in new bone formation, production of extracellular matrix (ECM) and cell differentiation when they were cultured onto polymerized polymethylmethacrylate (PMMA)

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(PDF) Complication of Polymethylmethacrylate Bone Cement ...

Nowadays, the bone cement used more frequently for implant fixation in orthopedics and bone surgery is polymethylmethacrylate (PMMA) cement [17], but this cement exhibits some disadvantages [5, 18 ...

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