(57 days)
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No
The description focuses solely on the mechanical design and material properties of a hip stem, with no mention of AI or ML capabilities.
No
The device is a prosthetic replacement for the femur, designed to mechanically restore function rather than provide therapeutic treatment.
No
Explanation: The device is described as a prosthetic replacement for the femur in hip replacements, which is a therapeutic device, not one used for diagnosis.
No
The device description clearly outlines a physical implant made of Cobalt-Chromium alloy, intended for surgical implantation. It details material properties, design features, and compatibility with other physical components, indicating it is a hardware device, not software.
Based on the provided text, the InterMoore Fracture Hip Stem is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the InterMoore Fracture Hip Stem is a prosthetic implant intended for surgical replacement of a portion of the femur in hip replacements. It is a physical device implanted into the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health based on such analysis.
Therefore, the InterMoore Fracture Hip Stem falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty).
Product codes
888.3360
Device Description
The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty). This device will be manufactured from either cast, forged, or wrought Cobalt-Chromium (CoCr) alloy conforming to ASTM Standards F75, F799, and F1537, respectively. This straight stem is offered in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a femoral replacement. In addition, the InterMoore Fracture Hip Stem:
- has a broad collar which wraps around the anterior, medial, and posterior sides.
- incorporates a stem-neck angle which replicates natural anatomy.
- is available in a fenestrated design for press-fit applications and a solid design for press-fit and cemented applications.
- has a 12/14 Morse-type male taper making it compatible with any Intermedics Orthopedics, Inc. 12/14 metal femoral head (e.g., modular femoral head, unipolar) or bipolar component which utilizes a 12/14 modular femoral head.
- provides lateral offsets ranging from 32 to 49mm.
- incorporates I-beam grooves along the anterior and posterior surfaces to increase rotational stability in vivo.
- has a roughened/grit-blasted surface below the collar, to enhance fixation in vivo.
- will incorporate a proximal, lateral fin to the fenestrated design. This fin will increase the rotational stability of the implant in vivo.
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 Femoral (Hemi-Hip)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
OCT 1 1996
K96 3155
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the InterMoore Fracture Hip Stem.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|-----------------------------------------------------------------------------------------------|
| Date: | September 20, 1996 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Hip Joint Femoral (Hemi-Hip) Metallic Cemented or
Uncemented Prosthesis, 21CFR 888.3360 |
| Common/Usual Name: | Hip Stem for Hemi-Arthroplasty or Total Hip Replacement |
| Trade/Proprietary Name: | InterMoore Fracture Hip Stem |
PRODUCT DESCRIPTION/SUBSTANTIAL EQUIVALENCE
The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty). This device will be manufactured from either cast, forged, or wrought Cobalt-Chromium (CoCr) alloy conforming to ASTM Standards F75, F799, and F1537, respectively. This straight stem is offered in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a femoral replacement. In addition, the InterMoore Fracture Hip Stem:
- i has a broad collar which wraps around the anterior, medial, and posterior sides.
- I incorporates a stem-neck angle which replicates natural anatomy.
- E is available in a fenestrated design for press-fit applications and a solid design for press-fit and cemented applications.
- 트 has a 12/14 Morse-type male taper making it compatible with any Intermedics Orthopedics, Inc. 12/14 metal femoral head (e.g., modular femoral head, unipolar) or bipolar component which utilizes a 12/14 modular femoral head.
- 트 provides lateral offsets ranging from 32 to 49mm.
- 부 incorporates I-beam grooves along the anterior and posterior surfaces to increase rotational stability in vivo.
- 트 has a roughened/grit-blasted surface below the collar, to enhance fixation in vivo.
- 트 will incorporate a proximal, lateral fin to the fenestrated design. This fin will increase the rotational stability of the implant in vivo.
The InterMoore Fracture Hip Stem is substantially equivalent to the Apollo Hip Stem™ offered by Intermedics Orthopedics, Inc., the Modular Austin Moore Hip Stem offered by Zimmer, Inc., the Bio-Moore II Stem offered by Biomet, Inc. and the Hip Fracture Stem offered by Howmedica, Inc.