(165 days)
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No
The summary describes a mechanical implant for hip replacement and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended for cemented replacement of the acetabular portion of the hip joint, which is a therapeutic intervention.
No
The device is described as an acetabular cup for hip replacement surgery, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical acetabular cup system made of biocompatible materials, intended for surgical implantation. It is a hardware device, not software.
No, 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: The Metagen All Poly Acetabular Cup is a physical implant designed to replace a portion of the hip joint. It is surgically implanted into the body.
- Intended Use: The intended use is for cemented replacement of the acetabular portion of the hip joint during surgery. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a medical device used in surgery, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.
Product codes
888.3350
Device Description
The Metagen All Poly Acetabular Cup System is a family of acetabular components designed for use in total hip arthroplasty, that are manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the predicate devices.
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
Acetabular portion of the hip joint
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
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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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§ 888.3350 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
K96403
Summary of Safety and Effectiveness
for
Metagen All Poly Acetabular Cup System
This safety and effectiveness summary for the Metagen All Poly Acetabular Cup System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.
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- Submitter: Metagen, LLC Origen Center 428 Technology Drive East Menomonie, WI 54751
Contact Person: Wesley Johnson Telephone: (715) 232-4880 Fax: (715) 235-9370
- Submitter: Metagen, LLC Origen Center 428 Technology Drive East Menomonie, WI 54751
Date Prepared: October 3, 1996
- Tradename: Metagen All Poly Acetabular Cup System Total Hip Prosthesis, Acetabular Component Common Name: Classification Name: Acetabular Component of Hip Joint, Hip Joint Metal/Polymer, Semi-Constrained Cemented Prosthesis (888.3350)
3. Predicate or legally marketed devices which are substantially equivalent:
- . Orthomet All-Poly Acetabular Cup (Orthomet)
- Charnley/Elite Plus All Poly Cups (DePuy) ●
- StelKast All Poly Cup (StelKast) .
4. Description of the device:
The Metagen All Poly Acetabular Cup System is a family of acetabular components designed for use in total hip arthroplasty, that are manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the predicate devices.
5. Intended Use:
The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
There are no significant differences between the Metagen All Poly Acetabular Cup and the systems currently being marketed, which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, material and intended use.