(77 days)
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No
The summary describes a mechanical implant (femoral head) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "intended to replace the femoral head in cases of femoral head and neck fracture, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed hip fracture treatment", which are conditions that require therapeutic intervention.
No
Explanation: The device description states its purpose is to "replace the femoral head" and describes its physical characteristics and materials. It is a surgical implant designed for treatment, not for diagnosing a condition.
No
The device description clearly states it is a physical implant constructed from Cobalt-Chrome Alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to replace the femoral head in the human body. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a physical implant made of Cobalt-Chrome Alloy, designed to be surgically inserted.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a replacement part.
N/A
Intended Use / Indications for Use
The Prime Modular Endo Heads, with the Prime Cemented Femoral Stems, are intended to replace the femoral head in cases of femoral head and neck fracture, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed hip fracture treatment.
Product codes
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Device Description
The Prime Modular Endo Heads feature a one piece spherical endo head and a Morse-type taper. This Morse-type taper provides for modular component selection, allowing the head to attach to the Prime Cemented Calcar Femoral Stems. The Prime Modular Endo Heads are provided in diameters from 36mm to 70mm in 1 mm (one millimeter) increments. It is constructed from Cobalt-Chrome Alloy, per ASTM F-1537. Sold Presterile.
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
femoral head
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): 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.
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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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§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
SEP 23 1996
(
ﺮ ﺍﻟﻤﻌﺘﻤﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
510(K) Summary of Safety and Effectiveness
| Submitter: | Orthopaedic Innovations, Inc.
825 South 8th Street, Suite 700
Minneapolis, MN 55404
Telephone: (612) 672-0021
Contact: Carolyn M. Steele Husten | | Date of Summary: 07/01/96 |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------|
| Product: | Classification Name: | Hip joint femoral (hemi-hip) metal/polymer cemented or
uncemented prosthesis, 21 CFR 888.3390 | |
| | Common Name:
Trade/Proprietary Name: | Modular Endo Head
Prime Modular Endo Head | |
| Substantially
Equivalent
Products | Hemi-Head by Orthomet
Modular Cathcart Endoprosthesis System by DePuy
Unipolar Head by Smith and Nephew Richards | | |
| Description | The Prime Modular Endo Heads feature a one piece spherical endo head and a Morse-
type taper. This Morse-type taper provides for modular component selection, allowing
the head to attach to the Prime Cemented Calcar Femoral Stems. The Prime Modular
Endo Heads are provided in diameters from 36mm to 70mm in 1 mm (one millimeter)
increments. It is constructed from Cobalt-Chrome Alloy, per ASTM F-1537. Sold
Presterile. | | |
| Intended
Use: | The Prime Modular Endo Heads, with the Prime Cemented Femoral Stems, are
intended to replace the femoral head in cases of femoral head and neck fracture, nonunion
of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis,
rheumatoid arthritis and revision of failed hip fracture treatment. | | |
| Comparison
to Substantial
Equivalent
Products: | All made of the same types of materials, equivalent in function and design. | | |
d:\FDA\Corresp\510k\PrimeEndo\510K060496