(82 days)
No
The document describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No.
A therapeutic device is typically involved in the treatment or prevention of a disease or condition through an active mechanism (e.g., drug delivery, stimulation, active repair). This device is a passive implant (a prosthetic stem) designed to replace a damaged anatomical structure, which is considered a reconstructive device rather than a therapeutic one in the typical regulatory sense.
No
Explanation: The device described is a femoral stem, which is a prosthetic implant used in hip replacement procedures to treat structural damage in the hip joint. It is a therapy device, not a diagnostic one.
No
The device description clearly details a physical, implantable femoral stem component for hip replacement surgery, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics and design of a femoral stem, which is a component of a hip prosthesis. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Ultima Total Hip System - Cemented Calcar Replacement Femoral Stem is indicated for use in total, partial, or revision hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint form rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, and nonunion of femoral fractures. Use of the prothesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The Ultima Cemented Calcar Replacement Stem is indicated for use only with PMMA bone cement.
Product codes
87 JDI
Device Description
The Ultima calcar replacement stem is a cemented femoral component for use in total or partial hip arthroplasty procedures. The stems are available in standard and long lengths. The standard length size range includes 3 base stem sizes, each available in 3 body lengths. The 3 base sizes are also each available in right and left long stem components; which are anatomically bowed. Also, the stems are available in 2 trunnion taper designs, i.e., 10/12 and 12/14.
The stem body design is derived from that of the primary Ultima stems #K924379. The proximal body of the Ultima cemented calcar stem, below the horizontal flange, is identical to that of the primary Ultima stems of equivalent size.
The Ultima calcar replacement stem features a vertical and horizontal flange, the former to provide support for the deficient or fractured greater trochanter and the latter to anatomically cap the resected calcar surface. The vertical flange has grooves located along it's anterior and posterior edges to provide a constraint in cases where cables/wires are used. The lateral face of the vertical flange features a macrotextured surface finish to provide some resistance to movement of the greater trochanter against the lateral flange.
A 2-lobed A/P hole is provided proximal to the horizontal flange to enabling passing a cable/wire through the stem when it is necessary to anchor the greater trochanter and/or a proximal bony fragment to the stem. The medial aspect of the stem immediately proximal to the horizontal flange features a gentle radius to enable cabling/wiring around the stem if necessitated.
The distal aspect of the standard length stems are fluted to provide resistance to rotational movement of the standard length stems also feature a distal hole to accept an optional PMMA distal centralizer component. The long stems are anatomically bowed to pass the isthmus and thereby bypass actual or potential bony defects.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
296 4795
Summary of Safety and Effectiveness Data for the ULTIMA® Total Hip System Cemented Calcar Replacement Femoral Stem FEB 1 9 1997
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person
Deana M. Boushell Associate Regulatory Affairs Specialist Phone: (508) 828-3107 (508) 828-3212 Fax:
Name of Device
| Proprietary Name: | Ultima® Cemented Calcar Replacement Stem |
|---|---|
| Common Name: | Cemented Calcar Replacement Femoral Stem |
| Classification Name: | Hip/joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class: | Class II by 21 CFR 888.3350 |
| Product Code: | 87 JDI |
| Owner/Operator No.: | 9001269 |
Device Classification
This device has been placed in Class II for Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR § 888.3350.
Statement of Substantial Equivalence ______________
The Ultima Cemented Calcar Replacement Femoral Stem is substantially equivalent in function to both the Howmedica HNR with Porus Coating, cleared for marketing under premarket notification #K922503 (September 21, 1992) and the Osteonics OmniFit Head/Neck Stem, cleared for marketing under premarket notification #K902712 (August 9, 1990). Further, the Cemented Calcar Replacement Femoral Stem is substantially equivalent in material and design to the ULTIMA Cemented Long Stem Femoral Component, previously cleared for marketing under premarket notification #K952859 (January 31, 1996).
The subject device is composed of similiar materials to the predicate devices mentioned above. Further, the intended use, design, and manufacture of the The Ultima Cemented Calcar Replacement Femoral Stem are substantially equivalent to those currently distributed. Additionally, the packaging and method of sterilization utilized for the The Ultima Cemented Calcar Replacement Femoral Stem are the same as those used for the previously mentioned predicate devices.
1
Indications for Use
The Ultima Total Hip System - Cemented Calcar Replacement Femoral Stem is indicated for use in total, partial, or revision hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint form rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, and nonunion of femoral fractures. Use of the prothesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The Ultima Cemented Calcar Replacement Stem is indicated for use only with PMMA bone cement.
Physical Description
The Ultima calcar replacement stem is a cemented femoral component for use in total or partial hip arthroplasty procedures. The stems are available in standard and long lengths. The standard length size range includes 3 base stem sizes, each available in 3 body lengths. The 3 base sizes are also each available in right and left long stem components; which are anatomically bowed. Also, the stems are available in 2 trunnion taper designs, i.e., 10/12 and 12/14.
The stem body design is derived from that of the primary Ultima stems #K924379. The proximal body of the Ultima cemented calcar stem, below the horizontal flange, is identical to that of the primary Ultima stems of equivalent size.
The Ultima calcar replacement stem features a vertical and horizontal flange, the former to provide support for the deficient or fractured greater trochanter and the latter to anatomically cap the resected calcar surface. The vertical flange has grooves located along it's anterior and posterior edges to provide a constraint in cases where cables/wires are used. The lateral face of the vertical flange features a macrotextured surface finish to provide some resistance to movement of the greater trochanter against the lateral flange.
A 2-lobed A/P hole is provided proximal to the horizontal flange to enabling passing a cable/wire through the stem when it is necessary to anchor the greater trochanter and/or a proximal bony fragment to the stem. The medial aspect of the stem immediately proximal to the horizontal flange features a gentle radius to enable cabling/wiring around the stem if necessitated.
The distal aspect of the standard length stems are fluted to provide resistance to rotational movement of the standard length stems also feature a distal hole to accept an optional PMMA distal centralizer component. The long stems are anatomically bowed to pass the isthmus and thereby bypass actual or potential bony defects.