(74 days)
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No
The document describes a mechanical implant (femoral hip stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The "ULTIMA Fx Femoral Hip Stem" is a medical device intended for use in total or partial hip replacement procedures to alleviate pain and disability caused by various forms of hip joint damage. This clearly falls under the definition of a therapeutic device designed to treat a medical condition.
No
The device description and intended use indicate that the ULTIMA Fx Femoral Hip Stem is an implantable prosthetic device for hip replacement procedures, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a femoral hip stem, which is a physical implant made of cobalt-chromium-molybdenum alloy. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, a congenital abnormality, a mental impairment, a disease or to monitor therapeutic measures.
- Device Description and Intended Use: The provided text clearly describes a femoral hip stem, which is an implantable medical device used in hip replacement surgery. Its intended use is to replace damaged parts of the hip joint due to various conditions.
- Lack of In Vitro Testing: There is no mention of this device being used to test specimens outside of the body. It is a physical implant placed within the body.
Therefore, based on the provided information, the ULTIMA Fx Femoral Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ULTIMA Fx Femoral Hip Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, traumatic and nonunion of femoral fractures. Use of the prosthesis 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 reconstruction techniques.
Product codes
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Device Description
The ULTIMA Fx Femoral Hip Stems will be offered in both a cemented design and uncemented design, both manufactured of cobalt-chromium-molybdenum alloy (Co-Cr-Mo). The stems will be offered with the following features:
| Feature | ULTIMA FX Cemented Stem | ULTIMA FX Press-Fit Stem |
|---|---|---|
| Distal Diameter | 8 - 11 mm | 10.5 - 15 mm |
| Length | 130 - 165 mm | 125 - 165 mm |
| Cement Mantle | 2.0 - 3.6 mm | N/A |
| Offset | 37 - 46 mm | 34 - 46 mm |
| Cobra Flange | Yes | No |
The ULTIMA Fx Femoral Hip Stems can be used in either the right or left hip, and are designed to mate with the following hip heads.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hip joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Biomet Hip Fracture System, Biomet Bi-Metric Hip System -- Collarless, Biomet APF Series Modular APF (Anatomical Press Fit), Zimmer VerSys™ Hip System, Wright McCutchen Hip Stem, Wright Nexus™ Hip Stem, Wright Resolution™ Microtextured Femoral Stem, Howmedica PercisionOsteolock™ Hip System, Osteonics Omnifit® Normalized Stem -- Collarless
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K96 3885
510(k) Summary September 24, 1996
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person: John Ferros Phone: 508.880.8287
Name of Device
Classification Name: Hip Joint Femoral Metal/Polymer Semi-Constrained Prosthesis Class II per 21 CFR § 888.3390. This falls under the Orthopaedics panel/87.
Common Name: Hip Prosthesis.
Trade Name/Proprietary Name: ULTIMA® Fx Femoral Hip Stems Performance Standards: No performance standards have been developed for this device.
Predicate Devices
| Biomet Hip Fracture System |
|---|
| Biomet Bi-Metric Hip System -- Collarless |
| Biomet APF Series Modular APF (Anatomical |
| Press Fit) |
| Zimmer VerSys™ Hip System |
| Wright McCutchen Hip Stem |
| Wright Nexus™ Hip Stem |
| Wright Resolution™Microtextured Femoral Stem |
| Howmedica PercisionOsteolock™ Hip System |
| Osteonics Omnifit® Normalized Stem -- Collarless |
Description of Device
The ULTIMA Fx Femoral Hip Stems will be offered in both a cemented design and uncemented design, both manufactured of cobalt-chromium-molybdenum alloy (Co-Cr-Mo). The stems will be offered with the following features:
| Feature | ULTIMA FX Cemented Stem | ULTIMA FX Press-Fit Stem |
|---|---|---|
| Distal Diameter | 8 - 11 mm | 10.5 - 15 mm |
| Length | 130 - 165 mm | 125 - 165 mm |
| Cement Mantle | 2.0 - 3.6 mm | N/A |
| Offset | 37 - 46 mm | 34 - 46 mm |
| Cobra Flange | Yes | No |
1
The ULTIMA Fx Femoral Hip Stems can be used in either the right or left hip, and are designed to mate with the following hip heads.
| Company Concession Company of
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|
| BLA MINNER BOOK - R B & F |
Hin .
A 1991
Infoolê | |
Intended Use
The ULTIMA Fx Femoral Hip Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, traumatic and nonunion of femoral fractures. Use of the prosthesis 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 reconstruction techniques.
Technological Characteristics Compared to Predicate Device
The ULTIMA Fx Femoral Hip Stems are technically equivalent to the predicate devices mentioned above.
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