(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.
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Image /page/0/Picture/0 description: The image shows the logo for Ortho Development. The logo consists of a stylized image of three curved lines above a solid black circle, with the words "ORTHO DEVELOPMENT" in bold, uppercase letters to the right. Above the logo is the text "K962648" and the date "SEP 19 1996".
Ortho Development Corporation 106 West 12200 South • Draper, Utah 84020 Phone (801) 553-9991 • Fax (801) 553-9993
Ortho Development Corporation 510(k) Summary
| Proprietary Name: | Primaloc™ Cemented Hip System |
|---|---|
| Common Name: | Cemented hip prosthesis |
| Classification Name: | Prosthesis, Hip, Hemi-JMetal/Polymer Cemented |
| Regulatory Class: | Class II |
Intended Use
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.
System Description
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.
Substantial Equivalence:
The Primaloc™ Cemented Hip System is a combination of state-of-the-art features and geometry; however, since it is similar to other cemented total hip systems currently in commercial distribution in terms of intended use, geometry, features, and materials, it is expected that its safety and effectiveness will be also be equivalent. The FDA cleared, commercially available cemented stems substantially equivalent to the Primaloc™ Cemented Hip System include:
Impact One-Piece Implant (Manufactured by Biomet) S-ROM OPC I Hip Stem for Cement (Manufactured by Joint Medical Products) Perfects (Manufactured by Wright Medical, formerly Orthomet)
The Primaloc™ Cemented Hip System is substantially equivalent to the above-referenced hip systems for the following reasons: (1) the intended use for all referenced stems is identical to that of the Primaloc™ stem which is primary surgery in total hip arthroplasty (NIND surgery or any of its composite diagnoses): (2) the referenced hip systems are all made from the same material, CoCr alloy, either cast of forged; (3) the dimensional characteristics regarding stem length and distal stem diameter are comparable; and (4) the referenced hip system geometry's are similar to the Primalor" in terms of design and features. While there are slight variances between the Primalor " and these referenced hip systems, there is no significant difference which would affect safety or efficacy.
| Contact person: | Michelle M. PerryManager, Regulatory Affairs/QA |
|---|---|
| Date: | June 21, 1996 |
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