(70 days)
No
The device description and performance data focus on the material and physical characteristics of a hip implant component, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for conditions such as rheumatoid arthritis, osteoarthritis, and avascular necrosis, functioning to replace hip components, which aligns with the definition of a therapeutic device.
No
This device is an acetabular shell used in hip replacement surgery, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a physical component made of UHMWPE, intended for surgical implantation as part of a total hip system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the CONSENSUS® Acetabular Shell, All UHMWPE is a component of a total hip replacement system. Its intended use is for surgical implantation to treat various hip conditions.
- Lack of Biological Sample Analysis: There is no mention of the device being used to analyze biological samples or provide diagnostic information based on such analysis.
Therefore, this device is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CONSENSUS® Acetabular Shell, All UHMWPE is indicated Intended Use: for use in:
-
- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
-
- Osteoarthrosis involving femoral and acetabular articular surfaces.
-
- Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
-
- Fracture-dislocation of the hip.
-
- Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
Product codes
Not Found
Device Description
The Consensus® Acetabular Shell, All UHMWPE is intended for use with the Consensus® Total Hip System as an alternative to the the metal acetabular shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Acetabular Shell, All UHMWPE is designed for use with size compatible Consensus® Total Hip System components: The Concensus® Acetabular Shell, All UHMWPE will be provided sterile and will be available in fourteen sizes for 22mm heads (42mm to 68mm increments), in twelve sizes for 26mm heads (46mm to 68mm in 2mm increments), and in eleven sizes for 28mm heads (48-68mm in 2mm increments). The material will be ultra high molecular weight polyethylene (UHMWPE), ASTM F648.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
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
Performance Data: The Consensus® Acetabular Shell, All UHMWPE, device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Conclusions from Non-clinical and Clinical Data: The Consensus® Acetabular Shell, All UHMWPE, is substantially equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Howmedica Acetabular Shell, All UHMWPE K912426
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
ATTACHMENT 8
Summary of Safety and Effectiveness 510(k) SUMMARY
APR - 1 1996
US MEDICAL PRODUCTS, INC. CONSENSUS® Acetabular Shell, All UHMWPE
US Medical Products, Inc. 12201 Technology Blvd. Suite 100 Austin, Texas 78727
William N. Thompson, Director Quality Assurance and Regulatory Affairs Voice (512) 257-4835 Fax (512) 257-8300 Date of Preparation: 15 Dec 1995
Trade Name: Consensus® Acetabular Shell, All UHMWPE
Common Name: Hip replacement prosthesis, Acetabular Shell, All UHMWPE
Classification Name: Class II device, under the following classification:
Prosthesis, Hip, Semi-Constrained Metal/ Polymer classification 21 CFR 888.3350
Substantial Equivalence: equivalent Acetabular Shell, All UHMWPE components are as follows:
Howmedica Acetabular Shell, All UHMWPE K912426 SE 8-21-91
Device Description: The Consensus® Acetabular Shell, All UHMWPE is intended for use with the Consensus® Total Hip System as an alternative to the the metal acetabular shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Acetabular Shell, All UHMWPE is designed for use with size compatible Consensus® Total Hip System components:
| Femoral Head, Biolox Ceramic | K922561 | SE 07-21-93 |
|---|---|---|
| Femoral Head, Zirconia | K955386 | SE 11/06/95 |
| Femoral Head, CoCrMo | K922561 | SE 07-21-93 |
The 22mm diameter, 26mm diameter, and 28mm Shells are intended to be used with compatible diameter femoral head components.
1
The Concensus® Acetabular Shell, All UHMWPE will be provided sterile and will be available in fourteen sizes for 22mm heads (42mm to 68mm increments), in twelve sizes for 26mm heads (46mm to 68mm in 2mm increments), and in eleven sizes for 28mm heads (48-68mm in 2mm increments). The material will be ultra high molecular weight polyethylene (UHMWPE), ASTM F648.
The CONSENSUS® Acetabular Shell, All UHMWPE is indicated Intended Use: for use in:
-
- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
-
- Osteoarthrosis involving femoral and acetabular articular surfaces.
-
- Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
-
- Fracture-dislocation of the hip.
-
- Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
Summary of Technological Characteristics: The Consensus® Acetabular Shell, All UHMWPE, is designed to articulate with the various Consensus® Hip femoral head components. The Concensus® Acetabular Shell, All UHMWPE, will be provided sterile and will be available in fourteen sizes for 22mm heads (42mm to 68mm in 2mm increments), in twelve sizes for 26mm heads (46mm to 68mm in 2mm increments), and in eleven sizes for 28mm heads (48-68mm in 2mm increments). The material will be ultra high molecular weight polyethylene (UHMWPE), ASTM F648.
Performance Data: The Consensus® Acetabular Shell, All UHMWPE, device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Conclusions from Non-clinical and Clinical Data: The Consensus® Acetabular Shell, All UHMWPE, is substantially equivalent to predicate devices.
Other Necessary Information: None Required