(88 days)
No
The device description focuses solely on the materials, dimensions, and mechanical components of a bipolar hip head, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a partial hip replacement, which is a therapeutic intervention aimed at alleviating pain and disability caused by specific conditions affecting the femoral head.
No
The device is a bipolar head used in partial hip replacement procedures; it is a prosthetic implant, not a diagnostic tool.
No
The device description clearly outlines physical components made of Co-Cr-Mo alloy and UHMWPE, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The provided text describes a J-FX Bipolar Head, which is a component used in partial hip replacement procedures. This is a surgical implant that is placed inside the body to replace damaged parts of the hip joint.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose based on in vitro analysis.
Therefore, based on the provided information, the J-FX Bipolar Head is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The J-FX Bipolar Head is indicated for use in partial hip replacement procedures for patients suffering severe pain and disability due to:
- femoral fracture
- · avascular necrosis of the femoral head
- · osteoarthritis
- · other abnormalities:
- where the major pathology affects the femoral head,
- where the acetabular cavity is normal and not deformed or weakened, and
- where acetabular replacement is not required or desirable.
Product codes
KWY
Device Description
The J-FX Bipolar Head is composed of an Co-Cr-Mo alloy shell (ASTM F75) and a ultra-high-molecular weight polyethylene (UHMWPE) liner. The liner is a three piece design consisting of a bearing insert, inner retaining ring and an outer locking ring. The bearing insert and inner retaining ring provide the bearing surface for the femoral hip head while the locking ring holds the liner assembly in place in the shell.
The outer diameter of the metal shell varies in size from 38 through 58 mm in 1 mm increments for use with the 22.225 mm UHMWPE liner. For the 28 mm UHMWPE liner, the size range for the metal shell is 42 through 58 mm in 1 mm increments. A 60 mm metal shell is also available for use with both the 22.225 mm and 28 mm UHMWPE liner.
Five sizes of polyethylene liners are available for the 22.225 mm J-FX Bilpolar head and four sizes for the 28 mm J-FX Bipolar head. With this availability of liner sizes, the mating of the full range of outer shell sizes are met. The polyethylene thickness ranges from 4.1 to 12.1 mm for the 22.225 mm head and 3.7 to 9.2 mm for the 28 mm 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)
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
K980801
Summary of Safety and Effectiveness Data for the J-FX Bipolar Head
MAY 2 9 1998
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person___________
Mary E. Gray Associate Regulatory Affairs Specialist Phone: (508) 828-3545 (508) 828-3212 Fax:
Name of Device________________________________________________________________________________________________________________________________________________________________
| Proprietary Name: | J-FXTM Bipolar Head |
|---|---|
| Common Name: | Metal/Polymer Femoral Head Endoprothesis (Bipolar Cup) |
| Classification Name: | Hip joint femoral (hemi-hip) metal/polymer cemented or |
| uncemented prosthesis. | |
| Regulatory Class: | Class II by 21 CFR 888.3390 |
| Product Code: | KWY |
| Owner/Operator No.: | 9001269 |
Device Classification
This device has been placed in Class II for Hip joint femoral (hemi-hip) metal /polymer cemented