(79 days)
Not Found
No
The summary describes a mechanical prosthetic device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a prosthetic replacement for the proximal femur in limb salvage procedures, which is a therapeutic intervention.
No
The device is described as a "Modular Replacement System - Proximal Femur" used for radical resection and replacement of the proximal femur, indicating it is an implantable prosthetic device for treatment, not diagnosis.
No
The device description clearly identifies it as a "Howmedica® Modular Replacement System - Proximal Femur," which is a physical implant used in surgical procedures, 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 that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this is a "Modular Replacement System - Proximal Femur" used for "radical resection and replacement of the proximal femur" in surgical procedures. This is a surgically implanted device, not a test performed on a sample outside the body.
The text describes a medical device used in vivo (within the body) for surgical reconstruction, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Howmedica® Modular Replacement System - Proximal Femur is presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the proximal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the proximal femur is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous hip arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the proximal femur, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Howmedica® Modular Replacement System - Proximal Femur
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparison to other legally marketed products was made, and testing of the modular tapers and fatigue testing of the proximal femur was presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
MAR 13 1997
510(k) Summary
ું જો રાજ્યન
Device: Howmedica® Modular Replacement System - Proximal Femur
The Howmedica® Modular Replacement System - Proximal Femur is presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the proximal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the proximal femur is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous hip arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the proximal femur, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
A comparison to other legally marketed products was made, and testing of the modular tapers and fatigue testing of the proximal femur was presented.
For information contact:
Margaret F. Crowe Manager, Requlatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7431