(32 days)
No
The document describes a mechanical implant (a hip replacement component) and its materials and dimensions. There is no mention of software, algorithms, data processing, or any other elements typically associated with AI/ML.
Yes.
The device is indicated for use in partial hip replacement procedures for patients with conditions like femoral neck fracture, avascular necrosis, and osteoarthritis, which are health conditions. Its function is to replace part of the hip joint to alleviate pain and disability.
No
The ULTIMA* Unipolar Head is a prosthetic device used in partial hip replacement procedures, designed to replace a damaged femoral head. It is an implantable medical device and does not perform any diagnostic function.
No
The device description clearly details a physical implant made of metal alloys, intended for surgical implantation. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The ULTIMA* Unipolar Head is a physical implant designed to replace the femoral head in a hip joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use clearly states it's for partial hip replacement procedures to address issues like fractures, avascular necrosis, and osteoarthritis. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The device description and intended use clearly indicate that this is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ULTIMA* Unipolar Head is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to:
-
- femoral neck fracture,
-
- avascular necrosis of the femoral head,
-
- osteoarthritis,
- abnormalities where: 4.
- the major pathology affects the femoral head, ●
- the acetabular cavity is normal and not deformed or weakened,
- acetabular replacement is not required or desirable. .
Product codes
87 JDG
Device Description
The ULTIMA* Unipolar Head is provided in a size range of 38mm to 63mm (outer diameter), in 1mm increments. Sizes from 44mm through 63mm are manufactured as a twopiece assembly. The two pieces are made of cast cobalt-chromium-molybdenum alloy conforming to ASTM F75. Both pieces are treated with hot isostatic pressing and solution annealing. The two cast pieces are machined and then joined permanently by electron beam welding to form a hollow unipolar head. Sizes from 38mm through 43mm are cast from cobalt-chromium-molybdenum alloy as a solid head, and are isostatic pressed and solution annealed before machining. Both of these size ranges are finish machined to the outer diameter size. The outer diameter is highly polished for articulation with the implant recipient's natural acetabulum.
The ULTIMA* Unipolar Head has a tapered bore which can receive a variety of Adapter Sleeves. The adapter sleeves can be tapered on the outside to the mate with the unipolar head, and tapered on the inside to mate with the appropriate femoral stem trunnion. The adapter sleeves are available in a 10/12 taper, in size increments for -3mm, +0mm, +5mm. and +10mm neck lengths; in a 11/13 taper, in size increments for +0mm, +6mm, and +12mm neck lengths: and in a 12/14 taper, in size increments for +0mm, +3.5mm, and +7mm neck lengths. The adapter sleeves are machined from cobalt-chromium-molybdenum alloy in wrought bar form conforming ASTM F799.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
Summary of Safety & Effectiveness Data for the ULTIMA* Unipolar Head and Adapter Sleeves
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
R965156
l. Contact Person
JAN 2 4 1997
Johanna Newman, Assoc. Regulatory Affairs Specialist, (508) 828-3268.
-
- Device Name
| Proprietary Name: | ULTIMA* Unipolar Head and Adapter Sleeves |
|---|---|
| Common Name: | Hip joint femoral (hemi-hip) metallic cemented or |
| uncemented prosthesis | |
| Classification Name: | Prosthesis, Hip |
| Regulatory Class: | Class II by 21 CFR § 888.3360 |
| Product Code: | 87 JDG |
| Owner/ Operator # | 9001269 |
Device Classification 3.
Classification for ULTIMA* Unipolar Head and Adapter Sleeves has been placed in Class II by 21 CFR § 888.3360
Statement of Substantial Equivalence 4.
The safety and effectiveness of the ULTIMA * Unipolar Head and Adapter Sleeves is substantially equivalent in terms of function to the Johnson & Johnson ULTIMA * Unipolar Modular Head and the Howmedica Unitrax Unipolar System. Furthermore, analysis results demonstrate that the ULTIMA* Unipolar Head and Adapter Sleeves meets the set criteria for the establishment of "substantial equivalence".
Indications for Use 5.
The ULTIMA* Unipolar Head is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to:
-
- femoral neck fracture,
-
- avascular necrosis of the femoral head,
-
- osteoarthritis,
- abnormalities where: 4.
- the major pathology affects the femoral head, ●
- the acetabular cavity is normal and not deformed or weakened,
- acetabular replacement is not required or desirable. .
1
Physical Description 6.
The ULTIMA* Unipolar Head is provided in a size range of 38mm to 63mm (outer diameter), in 1mm increments. Sizes from 44mm through 63mm are manufactured as a twopiece assembly. The two pieces are made of cast cobalt-chromium-molybdenum alloy conforming to ASTM F75. Both pieces are treated with hot isostatic pressing and solution annealing. The two cast pieces are machined and then joined permanently by electron beam welding to form a hollow unipolar head. Sizes from 38mm through 43mm are cast from cobalt-chromium-molybdenum alloy as a solid head, and are isostatic pressed and solution annealed before machining. Both of these size ranges are finish machined to the outer diameter size. The outer diameter is highly polished for articulation with the implant recipient's natural acetabulum.
The ULTIMA* Unipolar Head has a tapered bore which can receive a variety of Adapter Sleeves. The adapter sleeves can be tapered on the outside to the mate with the unipolar head, and tapered on the inside to mate with the appropriate femoral stem trunnion. The adapter sleeves are available in a 10/12 taper, in size increments for -3mm, +0mm, +5mm. and +10mm neck lengths; in a 11/13 taper, in size increments for +0mm, +6mm, and +12mm neck lengths: and in a 12/14 taper, in size increments for +0mm, +3.5mm, and +7mm neck lengths. The adapter sleeves are machined from cobalt-chromium-molybdenum alloy in wrought bar form conforming ASTM F799.
| | ULTIMA* Unipolar
Head and Adapter
Sleeves | ULTIMA* Unipolar
Modular Head | Howmedica Unitrax
Unipolar System |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------|
| | | K940190 | K902365 |
| DESIGN | | | |
| Range of sizes | 38mm-63mm
(1mm increments) | 38mm-65mm
(1mm increments) | 38mm-63mm
(1mm increments) |
| Adapter sleeve for
increased neck length | Yes | No | Yes |
| Number neck length
sizes | 10/12 taper: -3mm,
+0mm, +5mm, +10mm
11/13 taper: +0mm,
+6mm, +12mm
12/14 taper: +0mm,
+3.5mm, +7mm | +0mm, +5mm | -4mm, +0mm, +5mm,
+10mm |
| Morse-taper locking
mechanism to
modular femoral stem | Yes | Yes | Yes |
| INTENDED USE | | | |
| Partial hip replacement | Yes | Yes | Yes |
| MATERIALS | | | |
| Manufactured from
Co-Cr-Mo | Yes | Yes | Yes |