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The Primaloc™ Cemented Hip System is intended for single, cemented use during primary or revision arthroplasty surgery. Indications include: (1) Osteoarthritis or theumstoid arthritis, or other osteoardroses of the hip joint; (2) Certain femoral neck fractures; (3) Idiopathic avascular necrosis; (4) Post traumatic arthritis; (5) Benign or malignant bone turnors where sufficient bone stock is present to seat the prosthesis; (6) Previously failed implant.

The Primalor™ Cemented Hip is a straight tapered stem with a conical type collar at the neck. The stem is made of Cobalt Chromium Alloy (CoCr. ASTM F799), and the proximal cone incorporates macro grooves and a rough AlO, blasted surface for improved cement fixation. The femoral neck ends in a standard taper to interlock with Ortho Development Corporation Headloc™ CoCr modular femoral heads. A cement spacer, manufactured from PMMA, (polymethylmentals, ASTM F451), is affixed to the proximal medial portion of the cone to help prevent varus insertion.

A distal centralizer, also made from PPMA, is affixed to the distal end of the femoral stem within the medullary canal.

The Primaloc™ cement restrictor is manufactured from UHMWPE (ASTM F648). Prior to the introduction of bone cement into the medullary canal, the correctly sized cement restrictor is press-fit into the final location of the implant. The cement restrictor incorporates annular grooves over its length to provide flexibility upon insertion.

This document, a 510(k) Summary for the Primaloc™ Cemented Hip System, does not describe a study that involves software, AI, or medical image analysis.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert evaluations. The document focuses on establishing substantial equivalence for a physical medical device (a hip prosthesis) compared to other commercially available cemented hip systems.

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