(87 days)
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No
The document describes a mechanical hip implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is an implantable hip system intended to treat various conditions of the hip joint, such as osteoarthritis, fractures, and avascular necrosis, which directly addresses a disease or condition to restore health.
No
The device description clearly states it is a "Cemented Hip System" intended for use during "arthroplasty surgery," which is a surgical procedure to replace a joint, not a diagnostic process. The indications for use are conditions that lead to the need for joint replacement, not conditions the device is used to diagnose.
No
The device description clearly details physical components made of Cobalt Chromium Alloy, PMMA, and UHMWPE, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant (a cemented hip system) that is physically placed within the body during surgery.
- Intended Use: The intended use is for arthroplasty surgery to replace or repair the hip joint due to various conditions. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a medical device, but it falls under the category of implantable devices or surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip joint, femoral neck, medullary canal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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. Perry
Manager, Regulatory Affairs/QA |
|-----------------|-----------------------------------------------------|
| Date: | June 21, 1996 |