(107 days)
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No
The device description focuses on the materials and mechanical testing of a hip implant component, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, a 22 mm CoCr Head and Hooded Liner, is used in hip systems, implying its role in treating or managing a physical condition (hip replacement/repair), thus qualifying it as a therapeutic device.
No
Explanation: The device is described as a 22 mm CoCr Head and Hooded Liner made from biocompatible materials, which are components of a hip system. The description focuses on materials and mechanical testing, indicating it is an implantable medical device, not a diagnostic one.
No
The device description explicitly mentions physical components (CoCr Head and Hooded Liner) made from biocompatible materials, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on the materials and mechanical testing (fatigue) of a hip implant component. There is no indication that this device is used to test samples (like blood, urine, or tissue) outside of the body to diagnose or monitor a condition.
- Anatomical site: The device is intended for the "hip," which is an anatomical site within the human body, not a sample being tested in a lab.
- Device Description: The description details the physical components and materials of a hip implant, not reagents, instruments, or software used for in vitro analysis.
IVD devices are specifically designed for testing samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a prosthetic component intended for surgical implantation.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The 22 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application.
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
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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
Fatigue testing of the stem and 22 mm head was satisfied under previously released 510(k) submissions. Likewise, the liner testing was satisfied under previous 510(k) submissions since only the I.D. has been changed.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
Image /page/0/Picture/0 description: The image shows the logo for Stelkast Incorporated. The logo features a stylized letter 'S' above the company name. The word 'Stelkast' is in a bold, italicized font, and the word 'incorporated' is in a smaller, non-italicized font below and to the right of 'Stelkast'.
MAY - 2 1996
January 10, 1996
22 MM CAST CoCr HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
Summary of Safety and Effectiveness Information Upon Which The Substantial Equivalence Determination is Based [510(k) Summary]
The 22 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application.
Fatigue testing of the stem and 22 mm head was satisfied under previously released 510(k) submissions. Likewise, the liner testing was satisfied under previous 510(k) submissions since only the I.D. has been changed.
A smaller CoCr head with appropriate liner was manufactured to increase polyethylene minimal thickness in the smaller diameter acetabular cups. These components will supplement 28 mm CoCr heads and liners already released in the ProForm and Provident Hip Systems. Only certain neck lengths are available in the 22 mm head in order to provide adequate support.
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