(56 days)
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No
The device description focuses on the mechanical design and materials of a hip stem, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device, a hip stem, is used in total hip or hemi-hip arthroplasty, which are surgical procedures to replace part or all of the hip joint, thereby treating a medical condition.
No
Explanation: The device is described as a "Natural Hip System Porous Stem," which is an implant used in hip replacement surgery. It is a prosthetic device, not one used for diagnosis. The "Summary of Performance Studies" section mentions a theoretical stress analysis and fatigue test, which are related to the mechanical properties of an implant, not its diagnostic capabilities.
No
The device description clearly describes a physical hip stem implant, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: The description clearly details a surgical implant for hip replacement (total hip or hemi-hip arthroplasty). It describes the physical characteristics of a femoral stem, including materials, coatings, and design features.
- Anatomical Site: The anatomical site is the Hip, which is an internal part of the body, not a sample taken from the body for testing.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
- Any reagents, calibrators, or controls typically associated with IVD devices.
The device is a medical device, specifically a prosthetic implant, used in a surgical procedure.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Natural Hip System Porous Stem is identical in design geometry as compared to the predicate IOI Porous Natural Hip Stem, except for the reduction in the neck length. This design change was intended to address various patient population in cases of total hip or hemi-hip arthroplasty.
The Natural Hip System Porous Stem employs a Sulzer 12/14 configured neck trunnion for attachment to IOI's femoral heads, including Biolox and Zirconia ceramic heads. featuring a Sulzer 12/14 configured bore.
The Natural Hip System Porous Stem is available in both collared and collarless design. The Natural Hip System with Collar employs Cancellous Structured Titanium (CSTi™) porous coating on the inferior surface of the collar.
The proximal surface of the Natural Hip System Porous Stem employs anterior angulation to match the anatomic angulation of a natural femur. In addition, the proximal surface of the Natural Hip System Porous Stem employs circumferential CSTi™ porous coating
The distal portion of the Natural Hip System Porous Stem employs ribs and flutes on the anterior and posterior sides of the hip stem. In addition, the distal portion of the Natural Hip System Porous Stem employs a flared coronal slot.
The results of the theoretical stress analysis demonstrate that the Natural Hip System Porous Stem can successfully endure a fatigue test regimen of 10 million cycles without compromising the integrity of the hip stem.
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
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)
The results of the theoretical stress analysis demonstrate that the Natural Hip System Porous Stem can successfully endure a fatigue test regimen of 10 million cycles without compromising the integrity of the hip stem.
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
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§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
OCT 1 5 1996
Summary of Safety and Effectiveness for Natural Hip System Porous Stem
August 19. 1996
ﭘﯿﺮ
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Natural Hip System Porous Stem.
Submitter:
Intermedics Orthopedics, Inc. (IOI) 9900 Spectrum Drive Austin, Texas. 78717 Tel .: (512) 432-9900 Fax: (512) 432-9291
Contact Person:
Name: Sam Mirza Tel.: 512-432-9751 Fax: 512-432-9291
Regarding this submission:
Official Correspondent Name: Jacquelyn Hughes Tel .: 512-432-9687 Fax .: 512-432-9291
Proprietary name
Common Name:
Classification name:
Predicate Devices:
Natural Hip System Porous Stem
Total Hip Prosthesis - Femoral Component
Hip joint metal/ceramic/polymer semi-constrained porous coated uncemented prosthesis, 21 CFR 888.3358
The features employed by Natural Hip Stem Porous Stem are substantially equivalent to the features employed by the following predicate legally marketed devices:
Porous Natural Hip Stem: Intermedics Orthopedics. Inc. (510(k) K913060).
Stability Hip Stem: Depuy Inc. (510(k)s K915787 and K934457).
1
The Natural Hip System Porous Stem is identical in design geometry Device Description: as compared to the predicate IOI Porous Natural Hip Stem, except for the reduction in the neck length. This design change was intended to address various patient population in cases of total hip or hemi-hip arthroplasty.
The Natural Hip System Porous Stem employs a Sulzer 12/14 configured neck trunnion for attachment to IOI's femoral heads, including Biolox and Zirconia ceramic heads. featuring a Sulzer 12/14 configured bore.
The Natural Hip System Porous Stem is available in both collared and collarless design. The Natural Hip System with Collar employs Cancellous Structured Titanium (CSTi™) porous coating on the inferior surface of the collar.
The proximal surface of the Natural Hip System Porous Stem employs anterior angulation to match the anatomic angulation of a natural femur. In addition, the proximal surface of the Natural Hip System Porous Stem employs circumferential CSTi™ porous coating
The distal portion of the Natural Hip System Porous Stem employs ribs and flutes on the anterior and posterior sides of the hip stem. In addition, the distal portion of the Natural Hip System Porous Stem employs a flared coronal slot.
The results of the theoretical stress analysis demonstrate that the Natural Hip System Porous Stem can successfully endure a fatigue test regimen of 10 million cycles without compromising the integrity of the hip stem.