(306 days)
Not Found
No
The document describes a mechanical hip replacement component and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a hip replacement component, which is a prosthetic device designed to replace a damaged hip joint, not a device used for therapeutic treatment.
No
This device is a hip replacement component, used for treatment (joint replacement), not for diagnosing conditions.
No
The device description clearly details a physical, implantable femoral component made of cobalt alloy, which is a 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 is for hip replacement surgery in patients. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (femoral component) designed to be surgically placed within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not perform any such diagnostic testing on specimens.
The device described is a surgical implant used for therapeutic purposes (replacing a damaged hip joint), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Single use, camented or pressfit hip replacement component for use in patients requiring joint replacement due to trauma, disease or failed previous hip replacement surgery.
Product codes
KWY
Device Description
The Achantage MAPF Femoral Component is a cobalt alloy (Co-Cr-Mo) fernoral stam which is designed to articulate with any commercially available acetabular component. It has no linkage across the joint.
The MAPF devices are straight, as apposed to anatomic or curved in design. This eliminates the need for left and right configurations thus recucing the cost of inventory to the hospital. The Hosam distal goometry increases the strength and flexibility of the device. The lateral edge of the device is straight which anables the surgeon to rasp and asat the prosthesis, without creating a gap in the proximal lateral aspect of the femur. A lateral fin provides rotational stability. The duckbill type collar prevents subsidence.
Available in 6 sizes (diameters) for easier patient matching, all sizes are 160mm in length with a neck length of 32mm. Because this device is usually used in the older, low demand patient, it would most often be used in conjunction with a bipolar or endoprosthetic head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Moore Type Stern (Meditec), APF Moore-Type Femoral Stern (3M), Advantage MAPF Hip System (Kirschner), Ranawat/Burstein Hip System (Biomet, Inc)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
DEC 1 6 1996
Corporate Headquarters
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587
Shipping Address: Airport Industrial Park Warsaw. IN 46580
(219) 267-6639 Office (219) 267 8137 FAX
960643
Soonson Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: Advantage MAPF Hip Femoral Component
Classification Name: Prosthesis, Hip, Herni-, Femoral, Metal/Polymer, Cemented or Uncemented (KWY)
Summary of Safety and Effectiveness
Indications for Use: Single use, camented or pressfit hip replacement component for use in patients requiring joint replacement due to trauma, disease or failed previous hip replacement surgery.
Device Description: The Achantage MAPF Femoral Component is a cobalt alloy (Co-Cr-Mo) fernoral stam which is designed to articulate with any commercially available acetabular component. It has no linkage across the joint.
The MAPF devices are straight, as apposed to anatomic or curved in design. This eliminates the need for left and right configurations thus recucing the cost of inventory to the hospital. The Hosam distal goometry increases the strength and flexibility of the device. The lateral edge of the device is straight which anables the surgeon to rasp and asat the prosthesis, without creating a gap in the proximal lateral aspect of the femur. A lateral fin provides rotational stability. The duckbill type collar prevents subsidence.
Available in 6 sizes (diameters) for easier patient matching, all sizes are 160mm in length with a neck length of 32mm. Because this device is usually used in the older, low demand patient, it would most often be used in conjunction with a bipolar or endoprosthetic head.
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 the bone cement Deformity of the joint Cardiovascular disorders Fracture of the coment Implant loosening/migration Breakdown of the porous surface
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Tissue growth failure
Bone fracture Infection Hematoma Dislocation Excessive wear Nerve damage
Substantial Equivalence: In function and overall design, the Advantage MAPF Femoral Components are equivalent to almost all hip components on the market. These stems include:
Moore Type Stern (Meditec) APF Moore-Type Femoral Stern (3M) Advantage MAPF Hip System (Kirschner) Ranawat/Burstein Hip System (Biomet, Inc)