(210 days)
No
The device description focuses on the materials, design, and mechanical properties of the hip implant components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are biomechanical tests, not related to AI/ML performance metrics.
Yes
The device is indicated for the reduction or relief of pain and improved hip function in patients with various degenerative joint diseases and fractures, which are therapeutic goals.
No
This device is a hip arthroplasty implant used for replacement procedures, not for diagnosing medical conditions.
No
The device description clearly details physical components made of metal and plastic (acetabular cup and femoral head) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing structural and functional issues of the hip joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as an acetabular cup and femoral head, components of a total hip replacement system. These are physical implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring of a disease or condition through in vitro testing.
- Performance Studies: The performance studies described are biomechanical tests evaluating the physical properties and locking mechanism of the implant, not diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used directly in the body to replace a damaged joint.
N/A
Intended Use / Indications for Use
The U2 Acetabular Cup and Femoral Head are indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
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- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
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- Inflammatory degenerative joint disease such as rheumatoid arthritis;
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- Correction of function deformity;
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- Revision procedures where other treatments or devices have failed; and
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- Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes
LPH
Device Description
The U2 Acetabular Cup and Femoal Head are designated as an acetabular component and femoral head and are to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Cup has ten sizes of options, hemispherical design, porous-coated surface on the metallic shell, clustered bone screw holes, spherical screw holes for variable screw locking angle, PMMA cement plug, easy snap-in and take out mechanism, 12 options for angle adjustment, minimum 6.9 mm thickness of UHMWPE liner. The metallic shell is produced from cast Co-Cr-Mo alloy (ASTM F75). The plastic liner is machined from extruded UHMWPE bars (ISO 5834/I). The U2 28 mm femoral head is aimed to providing more choice for orthopaedic surgeon to perform total hip arthroplasty. The taper angle of 28 mm femoral head is identical with U1 26. mm femoral head (K994078). Therefore, U2 28 mm femoral head can be used wath our Ul and U2 hip stems. The U2 28 mm femoral head is available in -3, +0, +5, and +10 mm of neck length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Three biomechanical tests were performed, including push-out, lever-out and torque-out tests, to evaluate the locking mechanism of modular acetabular component. All test results are compared with U1 Hip System (K994078). The test results demonstrate that the integrity of locking mechanism between UHMWPE liner and metal acetabular shell of U2 Acetabular Cup is substantial equivalent to that of the predicate device.
Key Metrics
The static tensile and shear strength of the beaded porous coating are 27 MPa and 67 MPa respectively. The porosity of the porous coating ranges from 30 to 70 percent, the pore size ranges from 100 to 1000 microns and the thickness ranges from 500 to 1500 microns.
The range of motion of U2 Acetabular Cup is substantial equivalent to U1 Hip System (K994078).
Predicate Device(s)
UNITED U1 Hip Prosthesis (K994078)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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