(151 days)
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No
The device description focuses solely on the mechanical design and materials of a femoral component for hip replacement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device's description as a "femoral component" designed to articulate within a hip joint to restore function, combined with its classification by the FDA with predicate devices, indicates it is a therapeutic device intended for implantation to treat a medical condition.
No
Explanation: The device described is a femoral component of a hip implant, designed for articulation and biological fixation, not for diagnosing medical conditions.
No
The device description clearly describes a physical, metallic femoral stem, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a "metallic femoral stem" designed to be implanted in the hip. It is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
Biomet's Fenning Femoral Component is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint.
The stem has a 30° collar with plasma spraved porous coating circumferentially on the underside of the collar, including the cone; the porous coating extends to the proximal lateral 1/4 of the stem: 1.5 inches from the top laterally to below the collar medially. Porous coating is to achieve biological fixation to the surrounding bone by tissue, either bone or soft tissue, without the use of bone cement. The porous coating on the underside of a collar and the extended proximal lateral porous coating provide areas of potential tissue ingrowth in crucial regions of cortical bone.
The conical collar design provides a larger contact surface for stress transfer to the proximal femur via the collar wedging into the bone. The wedging of the implant into the canal allows the entire collar to sit on cortical bone occluding the proximal canal while providing rotational stability of the stem. There is no lateral collar eliminating the need to resect the greater trochanter.
The stem is tapered, following the natural contours of the canal. The stem below the porous coating to the middle portion is "grit blasted" for a roughened surface of 200 microinches. The distal half of the stem is smooth and fluted. The flutes provide additional rotational stability. There is a distal coronal slot to minimizes distal stem stiffness.
The device will be available in 5 stem sizes of diameters 9mm to 17mm at 2mm increments with corresponding stem lengths of 145mm to 165mm at 5mm increments. The stem is straight eliminating the need for left and right configurations.
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
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.
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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§ 888.3358 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
Image /page/0/Picture/0 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The string reads 'K96030'. The 'K' is a capital letter, followed by the numbers '96030'. The text is written in a bold, black font, and the handwriting style is somewhat stylized.
SUMMARY OF SAFETY AND EFFECTIVENESS.
Sponsor: Biomet. Inc. Airport Industrial Park Warsaw. Indiana 46580
Device: Fenning Femoral Component
Classification Name: Hip icint metal/polymer/metal semi-constrained porous coated uncemented prosthesis.
Device Description: Biomet's Fenning Femoral Component is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint.
The stem has a 30° collar with plasma spraved porous coating circumferentially on the underside of the collar, including the cone; the porous coating extends to the proximal lateral 1/4 of the stem: 1.5 inches from the top laterally to below the collar medially. Porous coating is to achieve biological fixation to the surrounding bone by tissue, either bone or soft tissue, without the use of bone cement. The porous coating on the underside of a collar and the extended proximal lateral porous coating provide areas of potential tissue ingrowth in crucial regions of cortical bone.
The conical collar design provides a larger contact surface for stress transfer to the proximal femur via the collar wedging into the bone. The wedging of the implant into the canal allows the entire collar to sit on cortical bone occluding the proximal canal while providing rotational stability of the stem. There is no lateral collar eliminating the need to resect the greater trochanter.
The stem is tapered, following the natural contours of the canal. The stem below the porous coating to the middle portion is "grit blasted" for a roughened surface of 200 microinches. The distal half of the stem is smooth and fluted. The flutes provide additional rotational stability. There is a distal coronal slot to minimizes distal stem stiffness.
The device will be available in 5 stem sizes of diameters 9mm to 17mm at 2mm increments with corresponding stem lengths of 145mm to 165mm at 5mm increments. The stem is straight eliminating the need for left and right configurations.
1
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to bone cement Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Tissue growth failure Delayed wound healing Fracture of the coment
Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Distocation Metal sensitivity
Substantial Equivalence: In function and overall design Biomet's Fenning Femoral Component is equivalent to almost all hip components on the market. These stems include:
PSL Total Hip (BioPro) 510(k) K922500 Conical Collar Hip (Kirschner) 510(k) K854046 C2 Osteocap Hip (Kirschner) 510(k) K861450