(190 days)
Rx90 Total Hip System, Centralian Precoat Hip Prosthesis, Ranawat/Burstein Cemented Primary Series, Buchalter/Fauser Femoral Component, Premise Total Hip System
Not Found
No
The description mentions "computer analysis" and "Numerical Shape Optimization (NSO)" based on cadaver data, which are computational design methods but do not explicitly indicate the use of AI or ML for real-time decision-making or analysis during clinical use. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is a hip prosthesis, which is explicitly designed to treat various medical conditions affecting the hip joint, such as osteoarthritis, avascular necrosis, rheumatoid arthritis, and fractures. Its purpose is to restore functional movement and alleviate symptoms for patients with these conditions, classifying it as a therapeutic device.
No
This device is a hip implant (prosthesis), a replacement device for a joint, not a device used to diagnose a medical condition.
No
The device description clearly states it is a hip prosthesis composed of physical components (femoral stem, modular head, acetabular component) made of cobalt-chromium alloy and polyethylene, intended for surgical implantation. This is a hardware device, not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the SHP Hip System is a single use implant composed of a femoral stem and an acetabular component. It is surgically implanted into the hip joint.
- Intended Use: The intended uses are for treating various hip joint conditions through surgical implantation, not for analyzing samples outside the body.
Therefore, the SHP Hip System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for use of the SHP Hip System include: 1) non inflammatory joint disease including ostecarthritis and avascular necrosis. 2) theurnatoid arthritis. 3) correction of functional deformity, 4) revision of failed joint reconstruction, and 5) treatment of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement which are unmanageable using other techniques.
The device is a single use implant intended for use with bone cement.
Product codes
Not Found
Device Description
The Scientific Hip Prosthesis or SHP Hip System is composed of an anatomic cobaltchromium alloy femoral stem with a modular head component and an all polyethylene acetabular component. The femoral component is anatomically proportioned, with sizing developed based on a computer analysis of 300 cadaver femurs to achieve a model of actual anatomic variation. The design was determined by Numerical Shape Optimization (NSO) and has been shown to reduce normal and shear stresses in the cement mantle and at the implant/cement/bone interface as compared to other femoral components in an FEM analysis. The proximal surface is roughened to facilitate greater cement adherence. PMMA spacers assist in placement of the stem. The stom is available in seven sizes with left and right configurations. The acetabular component features pegs to ensure a more uniform cement mantle and is available in seven outer diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, 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)
Rx90 Total Hip System (Biomet, Inc., Warsaw, IN), Centralian Precoat Hip Prosthesis (Zimmer, Inc., Warsaw, IN), Ranawat/Burstein Cemented Primary Series (Biomet, Inc., Warsaw, IN), Buchalter/Fauser Femoral Component (Biomet, Inc., Warsaw, IN), Premise Total Hip System (Howmedica, Rutherford, NJ)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Attachment II
Corporate Headquarters
Malling Address: P O. Box 587 Warsaw. IN 46581-0587
Stapping Address. Arport Industrial Park Warsaw IN 46580
- 267-6639 Office (219) 267-8137 FAX
SEP 17
Summary of Safety and Effectiveness
- Sponsor: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: SHP Hip System
Classification Name: Hip joint metal/polymer semi-constrained comented prosthesis (21 CFR 888.3350)
Device Description: The Scientific Hip Prosthesis or SHP Hip System is composed of an anatomic cobaltchromium alloy femoral stem with a modular head component and an all polyethylene acetabular component. The femoral component is anatomically proportioned, with sizing developed based on a computer analysis of 300 cadaver femurs to achieve a model of actual anatomic variation. The design was determined by Numerical Shape Optimization (NSO) and has been shown to reduce normal and shear stresses in the cement mantle and at the implant/cement/bone interface as compared to other femoral components in an FEM analysis. The proximal surface is roughened to facilitate greater cement adherence. PMMA spacers assist in placement of the stem. The stom is available in seven sizes with left and right configurations. The acetabular component features pegs to ensure a more uniform cement mantle and is available in seven outer diameters.
Indications: Indications for use of the SHP Hip System include: 1) non inflammatory joint disease including ostecarthritis and avascular necrosis. 2) theurnatoid arthritis. 3) correction of functional deformity, 4) revision of failed joint reconstruction, and 5) treatment of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement which are unmanageable using other techniques.
The device is a single use implant intended for use with bone cement.
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 coment Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Fracture of the component
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Excessive wear
Nerve Damage Bone fracture Infection Dislocation Hematoma
Substantial Equivalence: In function and overall design, the SHP Hip System is equivalent to many cemented hip components on the market. Commercially available devices for cemented use include:
Rx90 Total Hip System (Biomet, Inc., Warsaw, IN) Centralian Precoat Hip Prosthesis (Zimmer, Inc., Warsaw, IN) Ranawat/Burstein Cemented Primary Series (Biomet, Inc., Warsaw, IN) Buchalter/Fauser Femoral Component (Biomet, Inc., Warsaw, IN) Premise Total Hip System (Howmedica, Rutherford, NJ)
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