(923 days)
Not Found
Zimmer Anatomic Hip Prosthesis (and other predicate devices)
No
The summary describes a mechanical hip prosthesis and its physical characteristics, materials, and surgical benefits. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, a hip prosthesis, is designed to reduce pain and functional disabilities arising from various conditions like arthritis and avascular necrosis, which directly aligns with the definition of a therapeutic device.
No
Explanation: This device is a hip prosthesis, an implant used in total hip arthroplasty to replace a hip joint. Its purpose is therapeutic, not diagnostic. While some medical conditions serve as "diagnostic indications" for its use, the device itself does not perform any diagnostic function.
No
The device description clearly describes a physical implantable hip prosthesis made of titanium alloy and commercially pure titanium, intended for surgical implantation. This is a hardware device, not software.
Based on the provided text, the MAYO Hip is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure (total hip arthroplasty) involving the implantation of a device into the human body to replace a hip joint. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "short-stemmed, press-fit modular femoral component" intended to be "implanted into the human femur." This is a medical device for surgical use.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The MAYO Hip is a surgical implant used in a therapeutic procedure.
N/A
Intended Use / Indications for Use
The MAYO Hip is used in total hip arthroplasty, a surgical procedure restricted to patients with substantial pain or marked functional disabilities in which conservative treatment has not provided acceptable relief and who are not candidates for other less aggressive forms of surgery. This hip is indicated for noncemented use in skeletally mature individuals. Diagnostic indications include severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Product codes
Not Found
Device Description
The MAYO Hip Prosthesis is a short-stemmed, press-fit modular femoral component developed by Bernard F. Morrey, M.D., of the Mayo Clinic and is intended to be implanted into the human femur to replace a hip joint. The MAYO Hip incorporates several technological features of the Zimmer Anatomic Hip Prosthesis (and other predicate devices) such as the Morse-type tapered neck and fiber metal pads for bone ingrowth, and is made from the same materials (titanium alloy and commercially pure titanium) as the predicate devices. The femoral stem is collarless, has a dual taper (double wedge) body, and has a short distal stem (tail). The femoral stem is available in four sizes each of which can be utilized in the left or right hip.
The modular femoral stem is designed to mate with a femoral head through a Morse-type taper. The femoral head in turn articulates upon the UHMWPE liner of an acetabular component. The MAYO Hip Prosthesis meets the criteria of the generic device described in 21 CFR 888.3358.
The MAYO Hip supports a conservative approach to total hip arthroplasty by allowing for minimal femoral neck resection, minimal bone preparation, minimal stress shielding, absence of intramedullary fixation, reduction in blood loss, and potential for ease of revision.
The short distal portion of the stem is used to assist in proper placement of the stem and provides for rotary fixation. Immediate fixation is achieved through three-point (anteroposterior and lateral planes) fixation in the metaphyseal bone of the proximal femur. The stem does not rely upon intramedullary fixation, therefore the source of thigh pain is eliminated. Surgery time is reduced because the femoral medullary canal is not reamed or violated. This results in statistically significant less blood loss than that of a conventional, uncemented primary total hip arthroplasty. Additionally, reduction in the amount of metal (due to the short distal stem and double wedge shape) results in less exposure of a foreign body to the intramedullary canal. The conservative femoral neck resection, which preserves bone stock, will facilitate subsequent procedures should a revision of the hip be required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Femur
Indicated Patient Age Range
Skeletally mature individuals
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)
Performance data are available and include Finite Element Analysis (FEA), fatigue testing, characterization of the porous coating, information that addresses the potential for galvanic corroston, and eight years of clinical research that indicates a satisfactory clinical outcome. Clinical data also reveal a statistically significant reduction in blood loss during surgery and a statistically significant reduction in pain as compared to the BIAS Hip prostheses. These performance data validate the claim of substantial equivalence and provide evidence of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Statistically significant reduction in blood loss during surgery and a statistically significant reduction in pain.
Predicate Device(s)
Zimmer ® Anatomic Hip System HG MultiLock TM Hip Prosthesis BIAS ™ Total Hip System
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
JAN | 4 |997
Mayo Clinic
200 First Street Southwest
Rochester, Minnesota 55905 Telephone 507 284-2511
Bernard F. Morrey, M.D. Chair Department of Orthopedic Surgery
MAYO ® Hip Prosthesis Summary of Safety and Effectiveness
Submitted By:
B. F. Morrey, M.D. Mavo Clinic 200 First Street Southwest Rochester, Minnesota 55905
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Device Trade Name -
MAYO ® Hip Prosthesis -
Device Classification Name -
Hip joint metal/polymer/metal semi-constrained porous uncemented prosthesis -
Predicate Devices -
Zimmer ® Anatomic Hip System HG MultiLock TM Hip Prosthesis BIAS ™ Total Hip System -
Device Description
The MAYO Hip Prosthesis is a short-stemmed, press-fit modular femoral component developed by Bernard F. Morrey, M.D., of the Mayo Clinic and is intended to be implanted into the human femur to replace a hip joint. The MAYO Hip incorporates several technological features of the Zimmer Anatomic Hip Prosthesis (and other predicate devices) such as the Morse-type tapered neck and fiber metal pads for bone ingrowth, and is made from the same materials (titanium alloy and commercially pure titanium) as the predicate devices. The femoral stem is collarless, has a dual taper (double wedge) body, and has a short distal stem (tail). The femoral stem is available in four sizes each of which can be utilized in the left or right hip.
The modular femoral stem is designed to mate with a femoral head through a Morse-type taper. The femoral head in turn articulates upon the UHMWPE liner of an acetabular component. The MAYO Hip Prosthesis meets the criteria of the generic device described in 21 CFR 888.3358.
The MAYO Hip supports a conservative approach to total hip arthroplasty by allowing for minimal femoral neck resection, minimal bone preparation, minimal stress shielding, absence of intramedullary fixation, reduction in blood loss, and potential for ease of revision.
The short distal portion of the stem is used to assist in proper placement of the stem and provides for rotary fixation. Immediate fixation is
1
achieved through three-point (anteroposterior and lateral planes) fixation in the metaphyseal bone of the proximal femur. The stem does not rely upon intramedullary fixation, therefore the source of thigh pain is Surgery time is reduced because the femoral medullary canal eliminated. is not reamed or violated. This results in statistically significant less blood loss than that of a conventional, uncemented primary total hip arthroplasty. Additionally, reduction in the amount of metal (due to the short distal stem and double wedge shape) results in less exposure of a foreign body to the intramedullary canal. The conservative femoral neck resection, which preserves bone stock, will facilitate subsequent procedures should a revision of the hip be required.
- Intended use:
ーニ
The MAYO Hip is used in total hip arthroplasty, a surgical procedure restricted to patients with substantial pain or marked functional disabilities in which conservative treatment has not provided acceptable relief and who are not candidates for other less aggressive forms of This hip is indicated for noncemented use in skeletally mature surgery. individuals. Diagnostic indications include severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
l Comparison to Predicate Device
The MAYO Hip Prosthesis is substantially equivalent to the hip prostheses listed above as predicate devices. Each is designed as a femoral component that is intended to be implanted into the human femur to replace a hip joint. Each femoral component is manufactured from Tivanium Alloy and commercially pure titanium fiber pads which are metallurgically bonded to the proximal body of the stem. All are designed to be used without bone cement. Primary fixation is achieved by press fit. The predicate devices rely upon intramedullary fixation through the presence of a long distal stem while the MAYO Hip utilizes a shorter, more conservative, wedge shaped stem to achieve immediate three-point proximal femoral Secondary fixation is achieved through biological ingrowth into fixation. the fiber metal pads. Each femoral component uses a socket and Morse-type taper joint for attaching the femoral head to the stem.
- -Clinical and Nonclinical Data
Performance data are available and include Finite Element Analysis (FEA), fatigue testing, characterization of the porous coating, information that addresses the potential for galvanic corroston, and eight years of clinical research that indicates a satisfactory clinical outcome. Clinical data also reveal a statistically significant reduction in blood loss during surgery and a statistically significant reduction in pain as compared to the BIAS Hip prostheses. These performance data validate the claim of substantial equivalence and provide evidence of safety and effectiveness.