(148 days)
The Implex Ceramic Head is intended to provide articulation in cases of:
- Severely disabled joints as a result of degencrative arthritis or avascular 1 . necrosis.
- in Secondary revision of a previously unsuccessful femoral component or total hip replacement.
- Other hip problems where clinical experience has shown that alternative ਲ । modes of treatment are less likely to achieve satisfactory results.
- এ. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
- ಗ Non-union of femoral neck or head fractures.
- ల్లో Salvage of a failed primary or secondary total or hemi hip.
The Implex Ceramic Head is intended to be used in either cemented or uncemented applications depending on the intended use of the femoral stem it is mated with.
The Implex Ceramic Head is a ceramic femoral head. It is a spherical ball made from zirconia ceramic which has a tapered bore on one end of it. It is provided in one external diameter (28mm) and two (2) neck lengths (+0 Short, +6 Standard).
I am sorry, but the provided text describes a medical device (Ceramic Head for hip replacement) and its intended use, rather than an AI/ML device. Therefore, it does not contain information about acceptance criteria for an algorithm, study designs for AI/ML performance, sample sizes for training/test sets, expert adjudication methods, or other details relevant to AI/ML device evaluation.
Consequently, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets them in the context of an AI/ML device.
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K 955117
Implex Corp.
Ceramic Head 510(K)
Page 21
510(k) Summary of Safety and Effectiveness
K9655117
Date of Summary: 11/8/95
| Submitter: | Implex Corp.80 Commerce DriveAllendale, NJ 07401-1600 | APR - 5 906 |
|---|---|---|
| Phone: | 201/818-1800 | |
| FAX: | 201/818-0567 | |
| Contact: | James E. Malayter |
Product: Classification Name: Ceramic Femoral Head Component of Hip Joint, Metal/Ceramic/Polymer, Semi-constrained Comented or Non-Porous Uncomented Prosthesis (21 CFR 888.3353)
Generic Name: Ceramic Femoral Head Component of a Total Hip Replacement
Trade/Proprietary Name: Implex Ceramic Head
Substantially Equivalent Products:
PROZYR™ Zirconium Oxide Ceramic Head from Smith & Nephew Richards, Inc. Ceramic Bearing Head from Osteonics, Corp. Modular Ceramic Heads from Biomet. Inc. (K925345) Zr Ceramic Heads from Howmodica (K952418 & K946026)
Description: The Implex Ceramic Head is a ceramic femoral head. It is a spherical ball made from zirconia ceramic which has a tapered bore on one end of it. It is provided in one external diameter (28mm) and two (2) neck lengths (+0 Short, +6 Standard).
Intended Use: The Implex Ceramic Head is intended to provide articulation in cases of:
- Severely disabled joints as a result of degencrative arthritis or avascular 1 . necrosis.
- in Secondary revision of a previously unsuccessful femoral component or total hip replacement.
- Other hip problems where clinical experience has shown that alternative ਲ । modes of treatment are less likely to achieve satisfactory results.
- এ. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
- ಗ Non-union of femoral neck or head fractures.
- ల్లో Salvage of a failed primary or secondary total or hemi hip.
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Implex Corp. Ceramic Head 510(K) Page 22
The Implex Ceramic Head is intended to be used in either cemented or uncemented applications depending on the intended use of the femoral stem it is mated with.
Comparison to Substantially Equivalent Products:
All of the named ceramic heads use Zirconia ceramic materials. These materials have a history of demonstrated success as implant materials for femoral heads.
The Implex Ceramic Head is available in an outer diameter of 28mm and neck lengths of +0mm and +6mm. The other heads have outer diameters of 26mm, 28mm and 32mm and neck lengths of -5mm. -3mm. 0mm, +3mm, +4mm, +5mm, +6mm and +8mm.
All of the named ceramic heads are used to reconstruct the hip joint in combination with femoral stem and acetabular cup to provide appropriate joint spacing and femoral/acetabular articulation. In addition, all of the products are intended to be used in comented or cementless applications.
All of the named ceramic heads are spherical, with a tapered bore manufactured in one end.
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