(72 days)
No
The 510(k) summary describes a mechanical orthopedic implant (femoral component) and its associated components. There is no mention of software, algorithms, data processing, or any other elements that would suggest the use of AI or ML. The description focuses solely on the material, design, and physical characteristics of the device.
Yes.
The device is a femoral component indicated for treating various degenerative joint diseases, rheumatoid arthritis, and correcting functional deformities, which directly addresses medical conditions to restore function.
No
The device description indicates it is a femoral component used in joint replacement surgery, which is a therapeutic device, not a diagnostic one.
No
The device description clearly details a physical implant made of Co-Cr-Mo alloy and PMMA components, intended for surgical implantation. It does not describe software.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a "femoral component," which is a part of a hip implant used in surgery. It is a physical device implanted into the body.
- Intended Use: The intended uses listed are for treating conditions related to the hip joint itself (degenerative joint disease, arthritis, fractures, etc.) through surgical implantation.
Therefore, this device is a surgical implant, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Mallory/ Head Smooth femoral stem is indicated for use in:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Revision procedures where other treatment or devices have failed
-
- Treatment of nonunions, which are femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
This device is for use with bone cement.
Product codes
JDI
Device Description
The Mallory/Head Smooth femoral components are composed of Co-Cr-Mo alloy conforming to ASTM F-799 standards. The Mallory/Head Smooth is to be used with bone cement. A progressive increase in cross-sectional dimensions and overall length is seen throughout the range of sizes (size 1 -- 5). The straight stem design eliminates the need for left and right configurations.
The most defining feature of this series is the surface geometry and finish of the stem body. The finish is sisal buff in one direction (proximal to distal) around the entire stem with a roughness (Ra) value not less than 24 microinches. The surface is void of ledges, grooves, and collars. This smooth design will allow minute amounts of subsidence over an extended period of time. The smooth stem is used with the centralizer/sinker set so that the stem continues to remain tightly wedged in place rather than loosening progressively over time.
The centralizer/sinker set consists of two polymethylmethacrylate (PMMA) pieces. The sinker fits on the distal tip of the stem and creates a 2-3 mm (in length) void in the cement mantle. Without this void, distal to the tip of the stem, small amounts of subsidence would cause undesirable point loads in the cement. The centralizer is designed to fit on the central one-third of the stem and to provide a cement mantle of uniform thickness around the stem.
The Mallory/Head Smooth Femoral Component can be used with any Biomet modular head with a Type 1 taper, such as: Cobalt Chrome modular heads, Zirconia modular heads or an endoprosthesis head. Zirconia ceramic heads have been previously cleared in 510(k)'s: K905687, K913420, K925345, K943586. K964431. K991708. For metallic heads the surface of the bore of the head was measured to have a roughness (Rg) value of 34 microinches. The articulating surface roughness (Ra) value was found to be 5.6. The ceramic heads have a surface roughness of Rg
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
FEB 1 2000
SUMMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR: Biomet, Inc. Airport Industrial Park P. O. Box 587 Warsaw IN 46580 -0587
CONTACT PERSON: Tina Lakin (219) 267-6639 ext. 1816
DEVICE NAME: Mallory/ Head Smooth Femoral Stem
CLASSIFACTION NAME: Hip Femoral Component Prosthesis, Cemented, Metal (CFR 888.3360)
INDICATIONS FOR USE: Mallory/ Head Smooth femoral stem is indicated for use in:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Revision procedures where other treatment or devices have failed
-
- Treatment of nonunions, which are femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
DEVICE DESCRIPTION: The Mallory/Head Smooth femoral components are composed of Co-Cr-Mo alloy conforming to ASTM F-799 standards. The Mallory/Head Smooth is to be used with bone cement. A progressive increase in cross-sectional dimensions and overall length is seen throughout the range of sizes (size 1 -- 5). The straight stem design eliminates the need for left and right configurations.
The most defining feature of this series is the surface geometry and finish of the stem body. The finish is sisal buff in one direction (proximal to distal) around the entire stem with a roughness (Ra) value not less than 24 microinches. The surface is void of ledges, grooves, and collars. This smooth design will allow minute amounts of subsidence over an extended period of time. The smooth stem is used with the centralizer/sinker set so that the stem continues to remain tightly wedged in place rather than loosening progressively over time.
The centralizer/sinker set consists of two polymethylmethacrylate (PMMA) pieces. The sinker fits on the distal tip of the stem and creates a 2-3 mm (in length) void in the cement mantle. Without this void, distal to the tip of the stem,
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1
small amounts of subsidence would cause undesirable point loads in the cement. The centralizer is designed to fit on the central one-third of the stem and to provide a cement mantle of uniform thickness around the stem.
The Mallory/Head Smooth Femoral Component can be used with any Biomet modular head with a Type 1 taper, such as: Cobalt Chrome modular heads, Zirconia modular heads or an endoprosthesis head. Zirconia ceramic heads have been previously cleared in 510(k)'s: K905687, K913420, K925345, K943586. K964431. K991708. For metallic heads the surface of the bore of the head was measured to have a roughness (Rg) value of 34 microinches. The articulating surface roughness (Ra) value was found to be 5.6. The ceramic heads have a surface roughness of Rg