(87 days)
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.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.