(148 days)
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No
The document describes a ceramic femoral head, a mechanical component for hip replacement, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as an Implex Ceramic Head, intended to replace diseased or damaged parts of the hip joint in cases of degenerative arthritis, avascular necrosis, or other hip problems where conventional treatments are insufficient. This indicates its use in treating and alleviating medical conditions, which aligns with the definition of a therapeutic device.
No
The Implex Ceramic Head is a a ceramic femoral head designed to provide articulation in hip replacement surgeries. It is a prosthetic device for treatment, not diagnosis.
No
The device description clearly states it is a "ceramic femoral head," which is a physical implantable component, 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 describes a surgical implant for treating various hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a ceramic femoral head, a component of a hip replacement system. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device is used to treat the physical condition of the hip joint itself.
N/A
Intended Use / Indications for 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.
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.
Product codes
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Device 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).
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
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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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
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 Drive
Allendale, 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.
1
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.