(332 days)
Not Found
Not Found
No
The description details a physical, all-polyethylene acetabular cup with specific design features (grooves, indentations, sizes) and intended uses for hip replacement. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is an acetabular cup intended to resurface the acetabular socket in conditions like osteoarthritis and rheumatoid arthritis, which are medical diagnoses requiring treatment.
No
This device is an acetabular cup designed for surgical implantation in total hip replacement, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is an "all-polyethylene, hemispherical acetabular component," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to resurface the acetabular socket in cases of various hip conditions and for revision of failed prostheses. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a physical implant (an all-polyethylene acetabular component) designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The IM C-Ment Acetabular Cup will be used in indications which are the same as that for other acetabular components of cemented total hip replacement systems. Specifically, the IM C-Ment Acetabular Cup is intended to resurface the acetabular socket in cases of femoral head and neck fractures, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed prostheses.
The IM C-Ment Acetabular Cup is intended to be used in cemented applications only.
Product codes
888.3350
Device Description
The IM C-Ment Acetabular Cup is an all-polyethylene, hemispherical acetabular component with three (3) concentric grooves on the outer diameter and 3 circular indentations equally-spaced around the circumference near the middle of the cup. It is provided in eleven (11) sizes for the 28mm inner diameter, ranging from outer diameters of 40mm to 60mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabular socket in hip joint
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
OCT 10 1996
510(k) Summary of Safety and Effectiveness
Date of Summary: 11/3/95
| Submitter: | Implant Ideas, LLC
4036 Hagadorn Rd.
Okemos, MI 48864 |
|------------|-------------------------------------------------------------|
| Phone: | 517/333-1490 |
| Fax: | 517/333-1491 |
| Contact: | Brenda Sparks |
Classification Name: Acetabular Component of Hip Joint Metal/Polymer Semi-Product: Constrained Cemented Prosthesis (21 CFR 888.3350)
Generic Name: Acetabular Component of a Cemented Total Hip Replacement
Trade/Proprietary Name: IM C-Ment Acetabular Cup
Substantially Equivalent Products:
M.E. Muller Type Acetabular Cups from DePuy Charnley Type Acetabular Cup from DePuy New England Baptist Hip Cups from DePuy
Description: The IM C-Ment Acetabular Cup is an all-polyethylene, hemispherical acetabular component with three (3) concentric grooves on the outer diameter and 3 circular indentations equally-spaced around the circumference near the middle of the cup. It is provided in eleven (11) sizes for the 28mm inner diameter, ranging from outer diameters of 40mm to 60mm.
Intended Use: The IM C-Ment Acetabular Cup will be used in indications which are the same as that for other acetabular components of cemented total hip replacement systems. Specifically, the IM C-Ment Acetabular Cup is intended to resurface the acetabular socket in cases of femoral head and neck fractures, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed prostheses.
The IM C-Ment Acetabular Cup is intended to be used in cemented applications only.
· Comparison to Substantially Equivalent Products:
All of the named acetabular cups use UHMWPE and Stainless Steel materials. These materials have a history of demonstrated success as implant materials for acetabular cups.
The IM C-Ment Acetabular Cup is available in an inner diameter of 28mm. The other three cups have inner diameters of 22mm and 32mm. The IM C-Ment Acetabular Cup is available in outer diameters between 40 and 60mm. This is within the range of outer diameter sizes represented by the other three cups, i.e., 36 to 65mm.
1
All of the named acetabular cups are used to reconstruct the hip joint in combination with a femoral stem and head to provide appropriate joint spacing and femoral/acetabular articulation. In addition, all of the products are intended to be used in cemented applications.
All of the named acetabular cups are hemispherical, with a concentric I.D., concentric cement grooves, circular x-ray wires. The only exceptions to this are:
The New England Baptist Hip Cup has an eccentric I.D. and uses two circular x-ray wires rather than one.