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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.
This is a 510(k) summary for a medical device (Natural Hip System Porous Stem), not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets that criteria with respect to AI/ML performance is not applicable.
The document describes a orthopedic implant and focuses on demonstrating substantial equivalence to predicate devices, primarily through design comparisons, material specifications, and theoretical stress analysis. There is no mention of any AI or machine learning component in this device or its evaluation.
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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).
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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.
§ 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.