(78 days)
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No
The summary describes a mechanical implant (femoral stem) and its material properties and intended use, with no mention of software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is a component of a total hip system intended for the reconstruction of the proximal femur damaged by disease or trauma, which directly addresses a health condition.
No
The device is described as a femoral component of a Total Hip System, intended for reconstruction of the proximal femur. Its function is to replace or reconstruct a damaged anatomical part, not to diagnose a condition.
No
The device description clearly states it is a "femoral component of a Total Hip System" manufactured from "forged cobalt-chromium-molybdenum (Vitallium®) alloy," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Reliance® PF stem is a femoral component of a Total Hip System used for surgical reconstruction of the proximal femur. This is a device implanted in vivo (within the body) for structural support and joint function.
- Device Description: The description confirms it's a physical implant made of metal alloy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Reliance® PF stem is a femoral component of a Total Hip System. It is intended to be used for primary or secondary reconstruction of the proximal femur damaged as a result of inflammatory, non-inflammatory, or traumatic joint disease. The Reliance® PF stem is intended to be used in conjunction with Howmedica's V40 femoral heads, Acetabular components, and unipolar and bipolar components. The stem can be press-fit into the proximal femur for fixation by mechanical interlock, or affixed with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The Reliance® PF stem is a femoral component of a Total Hip System. The Reliance® PF stem is manufactured from forged cobalt-chromium-molybdenum (Vitallium®) alloy.
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
proximal femur
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)
Testing has demonstrated that the endurance load exceeds the Semlitsch minimum of 630 lbs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
510(k) Summary
Proprietary Name: Reliance® PF Femoral Stems
Common Name: Metallic Hip Stem
Classification Name and Reference:
21 CFR 888.3353
Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis.
Proposed Requiatory Class: Class II Device Product Code: LZO
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 1-17-97
The Reliance® PF stem is a femoral component of a Total Hip System. It is intended to be used for primary or secondary reconstruction of the proximal femur damaged as a result of inflammatory, non-inflammatory, or traumatic joint disease. The Reliance® PF stem is intended to be used in conjunction with Howmedica's V40 femoral heads, Acetabular components, and unipolar and bipolar components. The stem can be press-fit into the proximal femur for fixation by mechanical interlock, or affixed with bone cement.
The Reliance® PF stem is manufactured from forged cobalt-chromium-molybdenum (Vitallium®) alloy.
The substantial equivalence of the Reliance® PF stem is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's HNR Hip System (K903563), DRG Femoral component (K936126), Premium Femoral Component (K936127), and Dow Corning Wright's McCutchen Hip System.
Testing has demonstrated that the endurance load exceeds the Semlitsch minimum of 630 lbs.