(137 days)
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Not Found
No
The device description focuses on the material and mechanical design of a hip implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The sections specifically looking for mentions of AI, DNN, ML, image processing, training sets, test sets, performance studies, and key metrics are all marked as "Not Found".
Yes
The device is described as an implant used for treating various joint diseases and fractures, which falls under the definition of a therapeutic device designed to alleviate or cure medical conditions.
No.
The device description indicates it is an implantable orthopedic device (titanium stem with articular interface) used for treatment and correction of joint diseases and fractures, rather than for identifying or diagnosing a condition.
No
The device description clearly states it is an "implant" made of titanium and intended to articulate with an acetabular implant. This describes a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various conditions of the hip joint (noninflammatory degenerative joint disease, rheumatoid arthritis, fractures, etc.). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (titanium stem with a modular articular interface) designed to be surgically implanted into the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory results.
Therefore, this device falls under the category of a medical device (specifically, a surgical implant), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to be used for :
- noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis,
-
- rheumatoid arthritis,
- correction of functional deformity, 3.
- revision procedures where other treatments or devices have failed, and 4.
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement, unmanageable using other techniques.
Product codes
87LPH
Device Description
The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AJ- 4V (ASTM 1472) stem with a tapered proximal end intended to seat a conventional cobalt-chrome modular spheric articular interface. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. Th distal will be a smooth taper A-P and will be step-cut with parallel sides M-L. The proximal stem will be porous coated with commercially pure titanium beads on all surfaces excluding the articular interface trunnion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck and trochanteric fractures of the 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 10 1996
510(k) SUMMARY
Device:
Classification Name:
Prosthesis Hip, Semi-constrained, Metal / Polymer, Porous Uncemented
Classification No .: Common / Usual Name: Proprietary Name:
87LPH Modular femoral component and head Quatroloc Femoral Component and Head
Manufacturer Identification:
Whiteside Biomechanics. Inc. 12634 Olive Blvd. Creve Coeur, MO 63141
Establishment Registration Number: 1932213
Device Description:
The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AJ- 4V (ASTM 1472) stem with a tapered proximal end intended to seat a conventional cobalt-chrome modular spheric articular interface. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. Th distal will be a smooth taper A-P and will be step-cut with parallel sides M-L. The proximal stem will be porous coated with commercially pure titanium beads on all surfaces excluding the articular interface trunnion.
Intended Use:
This device is intended to be used for :
- noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis,
-
- rheumatoid arthritis,
- correction of functional deformity, 3.
- revision procedures where other treatments or devices have failed, and 4.
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement, unmanageable using other techniques.
Additional Information:
This femoral component is made of wrought titanium 6A1-4V (ASTM F1472). The proximal portion of the stem will be porous coated on all surfaces, excluding the ball trunnion. The porous coating will consist of 3 layers (0.030" total thickness) of commercially pure titanium beads The device is to be sterilized with 100% ethylene oxide and nitrogen in (-45+60Mesh). accordance with AAMI guidelines for sterilization.