cbe911d8-5302-4f59-9568-4847938dbc24NewPublished12023-02-032023-01-26In Commercial Distribution04026575234530PrimaryGS1Embrace Shoulder System641-075/22315675488WALDEMAR LINK GmbH & Co. KG1truefalsefalsefalsefalsetruefalsetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK21299200034197Uncoated shoulder humeral stem prosthesisA sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.trueActivePHXshoulder prosthesis, reverse configurationHSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTEDPAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cementedtruefalse