(82 days)
Not Found
Not Found
No
The document describes a mechanical implant (femoral component) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a femoral component used in total hip arthroplasty to reduce pain and improve hip function, addressing various degenerative joint conditions and fractures.
No
The device is a femoral component used in total hip arthroplasty, which is a treatment (therapeutic) procedure, not a diagnostic one. Its purpose is to implant a component to reduce pain and improve function, not to identify or characterize a medical condition.
No
The device description clearly states it is a "femoral component" consisting of a "femoral stem" and "polyethylene seal," which are physical hardware components used in hip arthroplasty.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The BRIDGE™ Long Stem Femoral Component is a physical implant designed to be surgically placed in the hip joint. It is a prosthetic device used to replace damaged bone.
- Intended Use: The intended use clearly describes its function as a component in total hip arthroplasty for treating various hip conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The BRIDGE™ Long Stem Femoral Component is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1) necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and,
- ર) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes
Not Found
Device Description
The BRIDGE™ Long Stem Femoral Component consists of two parts, a femoral stem designed with a primary mid-shaft metal seal and a polyethylene seal that provides a secondary seal at the mid-shaft region of the femoral stem. There are 20 sizes (ten right and ten left) for the BRIDGE™ Long Stem Femoral Component. This device is intended for cemented use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, femoral
Indicated Patient Age Range
skeletally mature patients
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)
The BRIDGE® Long Stem Femoral Component demonstrates acceptable fatigue strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The BRIDGE™ Hip System manufactured by Wright Medical Technology, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a stylized letter W. The W is formed by two triangles that are connected at their apexes. A white line cuts through the right triangle, creating a visual break in the shape. The overall design is simple and geometric.
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo is in black and white and features the word "WRIGHT" in large, bold letters. Below the name is the text "MEDICAL TECHNOLOGY, INC." and the address "5677 AIRLINE ROAD".
JAN | 4 |997
5 6 7 7 AIRLINE ROAD
ARLINGTON, TN 38002
901-867-9971
510(k) Summary
| Contact Person: | Cliff Kline |
|---|---|
| Date Prepared: | September 23, 1996 |
| Trade/Proprietary Name: | BRIDGE™ Long Stem Femoral Component |
| Common Name | Prosthesis, hip, semi-constrained, metal/ceramic/polymer/ |
| cemented or non-porous, cemented | |
| Product Classification: | Class II (888.3353) |
| Predicate Device: | The BRIDGE™ Hip System manufactured by Wright |
| Medical Technology, Inc. |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirments of 21 CFR §807.92.
Description/Intended Use
The BRIDGE™ Long Stem Femoral Component consists of two parts, a femoral stem designed with a primary mid-shaft metal seal and a polyethylene seal that provides a secondary seal at the mid-shaft region of the femoral stem. There are 20 sizes (ten right and ten left) for the BRIDGE™ Long Stem Femoral Component. This device is intended for cemented use only.
The BRIDGE™ Long Stem Femoral Component is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1) necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and,
- ર) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Testing
The BRIDGE® Long Stem Femoral Component demonstrates acceptable fatigue strength.