(175 days)
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No
The device description focuses on the mechanical design and materials of a revision stem for the femur, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies described are mechanical tests.
Yes
The device, a "Wagner Revision Stem," is an implantable prosthesis for the proximal femur, intended to treat deficiencies due to bone resorption or damage. This directly targets the repair and restoration of bone function, which is a therapeutic purpose.
No
Explanation: The device description clearly states it is a "Wagner Revision Stem" intended for "cementless application where primary fixation occurs predominantly in the distal region" in the "proximal femur." This describes a surgical implant, not a device used to diagnose a condition.
No
The device description clearly describes a physical implant (Wagner Revision Stem) made of metal, intended for surgical implantation in the proximal femur. It discusses physical characteristics like cross-section, ribs, lengths, and diameters, and mentions static and dynamic testing of the physical device. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "Wagner Revision Stem" intended for "cementless application where primary fixation occurs predominantly in the distal region and is primarily used in clinical situations where there are deficiencies in the proximal femur". This describes a surgical implant used within the body, not a test performed on a sample outside the body.
- Anatomical Site: The anatomical site is the "proximal femur", which is a part of the human skeleton.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity associated with in vitro diagnostics.
Therefore, this device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Wagner Revision Stem incorporates a circular cross-section with eight equally spaced conical anchorage ribs (or flutes) which run the entire length of the stem. This device is intended for cementless application where primary fixation occurs predominantly in the distal region and is primarily used in clinical situations where there are deficiencies in the proximal femur due to extensive bone resorption and/or damage in the prosthetic bed.
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
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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)
Static and dynamic testing were performed, verifying that the additional sizes exhibit sufficient strength for clinical use.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Interim 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 Wagner Revision Stem.
్నారాలు
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9687 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Date: | February 9, 1996 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis,
21CFR 888.3353 |
| Common/Usual Name: | Femoral component |
| Trade/Proprietary: | Wägner Revision Stem |
PRODUCT DESCRIPTION/SUBSTANTIAL EQUIVALENCE:
The Wagner Revision Stem incorporates a circular cross-section with eight equally spaced conical anchorage ribs (or flutes) which run the entire length of the stem. This device is intended for cementless application where primary fixation occurs predominantly in the distal region and is primarily used in clinical situations where there are deficiencies in the proximal femur due to extensive bone resorption and/or damage in the prosthetic bed.
Currently, the Wagner Revision Stem is offered in four stem lengths (190, 225, 265 and 305mm) with distal diameters ranging from 14-20mm, and 14-25mm (in 1mm increments) for the 190, 225, and 265/305mm lengths respectively. The number of size offerings is being increased to include a stem length of 345mm with distal diameters of 14-25mm (1mm increments) and a stem length of 385mm with distal diameters of 14-25mm (1mm increments).
The additional sizes are identical in configuration to the original Wagner Stems, but have been designed in proportion to the sizes already available. Static and dynamic testing were performed, verifying that the additional sizes exhibit sufficient strength for clinical use.
The modified Wagner Revision Stem is substantially equivalent to the Müller Type Proximal Femur marketed by Howmedica and the Proximal Third Femoral Prosthesis marketed by DePuy.