(30 days)
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No
The document describes a design modification to a femoral stem for hip replacement and does not mention any AI or ML components.
Yes
The device is a femoral stem used in hip replacement surgeries to treat painful joint diseases, fractures, or necrosis, which are therapeutic interventions.
No
Explanation: The device is a femoral stem for hip replacement, which is an orthopedic implant used for treatment, not diagnosis. The text describes its use for treating various conditions such as fractures, necrosis, and arthritis of the hip.
No
The device description clearly states it is a femoral stem fabricated from forged cobalt chromium alloy, which is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications clearly describe a surgical implant for hip replacement, addressing conditions like fractures, necrosis, and arthritis. These are clinical conditions treated directly within the body, not through in vitro testing of samples.
- Device Description: The device is described as a "femoral stem" fabricated from a cobalt chromium alloy, intended for surgical implantation. This is consistent with a medical device used in surgery, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, this device is a surgical implant, specifically a femoral stem for hip replacement, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Like the predicate devices, the subject devices are intended for primary and revision total or hemi-hip arthroplasty. These devices are intended for use in cemented applications.
Indications for Use:
Indications for use as a Bipolar or Hemi-Hip Replacement:
- Femoral head/neck fractures or non-unions .
- Aseptic necrosis of the femoral head; .
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion;
- Pathological conditions or age considerations which indicate a more conservative . I amongiour conditions of up voidance of the use of bone cement in the acetabulum;
- Salvage of failed total hip arthroplasty. .
Indications for use as part of a Total Hip Replacement include:
OR
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis;
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure;
- Procedury, . are less likely to achieve satisfactory results.
Product codes (comma separated list FDA assigned to the subject device)
JDI
Device Description
This Special 510(k) submission is intended to address a design modification to the Omnifit EON Femoral Stems. This modification will create the new subject device, hereby referred to as the Super EON Plus femoral stems to expand the product line. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The subject device is fabricated from forged cobalt chromium alloy conforming to ASTM F 799. The Super EON Plus femoral stems are available in 127 degree and 132 degree neck angles and range in size from size #4 through size #10.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
Fatigue testing of the subject Super EON Plus femoral stems demonstrated that the body and neck strength are comparable to the body and neck strength of the predicate Omnifit EON Femoral Stems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Proprietary Name: | Super EON Plus Femoral Stems | Omnifit EON Femoral Stems |
| Common Name: | Artificial Hip Component | Artificial Hip Component |
| Classification Name and | ||
| Reference: | 21 CFR §888.3350 | |
| Hip Joint Metal/ Polymer Semi- | ||
| constrained Cemented Prosthesis | 21 CFR §888.3350 | |
| Hip Joint Metal/ Polymer Semi- | ||
| constrained Cemented Prosthesis | ||
| Proposed Regulatory Class: | II | II |
| Device Product Code: | (87) JDI | (87) JDI |
| For Information contact: | Jennifer A. Daudelin. Regulatory Affairs | |
| Howmedica Osteonics Corp. | ||
| 59 Route 17 | ||
| Allendale, NJ 07401-1677 | ||
| (201) 831-5379 | ||
| Fax: (201) 760-8435 | ||
| Email: jdaudelin@howost.com |
Special 510(k) Summary – SUPER EON PLUS FEMORAL STEMS
Device Description
This Special 510(k) submission is intended to address a design modification to the Omnifit EON Femoral Stems. This modification will create the new subject device, hereby referred to as the Super EON Plus femoral stems to expand the product line. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The subject device is fabricated from forged cobalt chromium alloy conforming to ASTM F 799. The Super EON Plus femoral stems are available in 127 degree and 132 degree neck angles and range in size from size #4 through size #10.
Predicate Device
The predicate Omnifit EON femoral stems were found substantially equivalent via the 510(k) process in K983226.
1
Fatigue testing of the subject Super EON Plus femoral stems demonstrated that the body and neck strength are comparable to the body and neck strength of the predicate Omnifit EON Femoral Stems.
2
2
Intended Use
Like the predicate devices, the subject devices are intended for primary and revision total or hemi-hip arthroplasty. These devices are intended for use in cemented applications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing service to the individual and the family. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.
Public Health Service
APR 26.2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer A. Daudelin Regulatory Affairs Associate Howmedica Osteonics Corporation 59 Route 17 Allendale. New Jersey 07401-1677
Re: K020989
Trade Name: Super EON Plus Femoral Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal / Polymer / Semi-Constrained / Cemented Prosthesis Regulatory Class: II Product Code: JDI Dated: March 26, 2002 Received: March 27, 2002
Dear Ms. Daudelin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Jennifer A. Daudelin
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
b. Mark N. Milkman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
page lot
510(k) Number (if known):
Device Name: Super EON Plus Femoral Stems
Indications for Use:
Indications for use as a Bipolar or Hemi-Hip Replacement:
- Femoral head/neck fractures or non-unions .
- Aseptic necrosis of the femoral head; .
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular . involvement or distortion;
- Pathological conditions or age considerations which indicate a more conservative . I amongiour conditions of up voidance of the use of bone cement in the acetabulum;
- Salvage of failed total hip arthroplasty. .
Indications for use as part of a Total Hip Replacement include:
OR
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis;
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure;
- Procedury, . are less likely to achieve satisfactory results.
Mark n millerson
(Division Sign-Of (Division of General, Restorative and Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE - CONFINE WANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)