(64 days)
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No
The document describes a hip stem implant and its intended uses, focusing on material and mechanical properties evaluated through finite element analysis. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a hip stem intended for hip replacement, which directly treats painful and disabling joint diseases.
No
This device is a hip implant (hip stems, femoral head, acetabular component) used for hip replacement procedures, which is a therapeutic device, not a diagnostic one. Its stated uses are to treat conditions like fractures, necrosis, and arthritis.
No
The device description explicitly states the device is a hip stem, which is a physical implant made of cobalt chromium alloy. This is a hardware device, 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 intended use and indications clearly describe a surgical implant for hip replacement (hemi-hip and total hip arthroplasty). This is a therapeutic device used in vivo (within the body) to treat conditions like fractures, arthritis, and necrosis.
- Device Description: The device is described as a "hip stem" forged from cobalt chromium alloy. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The subject devices are intended for single use only, and may be used with or without bone cement. The subject devices may be used with an Howmedica Osteonics Endo Head and Neck Extension for hemi-hip arthroplasty, a UHR® Universal Head for bipolar hip replacement, or a Howmedica Osteonics C-Taper cobalt chromium head and Howmedica Osteonics acetabular component for conventional total hip arthroplasty.
Indications:
For use as a bipolar hip replacement
- Femoral head/neck fractures or non-union, .
- Asentic necrosis of the femoral head, ●
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acctabular . involvement or distortion,
- Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum,
- Salvage of failed total hip arthroplasty .
- Femoral Neck Fractures .
For use as a total hip replacement
- Painful, disabling joint disease 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,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results,
- Clinical circumstances that require an altered femoral resection level due to proximal ● fracture, bone loss, or calcar lysis.
Product codes (comma separated list FDA assigned to the subject device)
87 – JDI, 87 – LWJ
Device Description
The subject and predicate hip stems are both hip fracture stems intended for cemented use. The subject devices and the predicate 6076 series hip stems (K954598) are forged from ASTM F-799 cobalt chromium alloy.
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
Indicated Patient Age Range
Not Found
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)
Finite Element Analysis was used to evaluate the strength of the neck and body regions of the hip 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
AUG - 8 2003
Omnifit® HFx Hip Stcms
י
Image /page/0/Picture/2 description: The image shows handwritten text on a white background. The text includes the alphanumeric string "K031744" on the first line. The second line contains the words "page 10 of 2" with "s10(k)" written below the number 2. The handwriting appears to be somewhat rough and uneven.
510(k) Summary: Omnifit® HFx Hip Stem Series
| Proprietary Name: | Omnifit® HFx Hip Stem Series |
|---|---|
| Common Name: | Femoral Hip Stems |
| Classification Name and Reference: | Hip joint, metal/polymer semi-constrained, |
| cemented prosthesis | |
| 21 CFR §888.3350 | |
| Hip joint femoral (hemi-hip) metallic cemented or | |
| uncemented prosthesis | |
| 21 CFR §888.3360 | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 – JDI: Prosthesis, hip, semi-constrained, |
| cemented | |
| 87 – LWJ: Prosthesis, hip, semi-constrained, | |
| metal/polymer, uncemented | |
| Predicate Proprietary Name(s): | Osteonics ODC/ODC Plus Hip Stems, Omnifit X |
| (Eon) Hip Stems | |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code(s): | 87 JDI, KWL |
| Submitted By: | Howmedica Osteonics Corp. |
| 59 Route 17 | |
| Allendale, New Jersey 07401-1677 | |
| (201) 825-4900 | |
| Contact Information: | Debra Bing |
| Phone: (201) 831-5413 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | July 23, 2003 |
1
Omnifit® HFx Hip Stems
Description/Technological Comparison
031744
The subject and predicate hip stems are both hip fracture stems intended for cemented use. The subject devices and the predicate 6076 series hip stems (K954598) are forged from ASTM F-799 cobalt chromium alloy.
Intended Use
The subject devices are intended for single use only, and may be used with or without bone cement. The subject devices may be used with an Howmedica Osteonics Endo Head and Neck Extension for hemi-hip arthroplasty, a UHR® Universal Head for bipolar hip replacement, or a Howmedica Osteonics C-Taper cobalt chromium head and Howmedica Osteonics acetabular component for conventional total hip arthroplasty.
Indications:
For use as a bipolar hip replacement
- Femoral head/neck fractures or non-union, .
- Asentic necrosis of the femoral head, ●
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acctabular . involvement or distortion,
- Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum,
- Salvage of failed total hip arthroplasty .
- Femoral Neck Fractures .
For use as a total hip replacement
- Painful, disabling joint disease 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,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results,
- Clinical circumstances that require an altered femoral resection level due to proximal ● fracture, bone loss, or calcar lysis.
Testing Summary
Finite Element Analysis was used to evaluate the strength of the neck and body regions of the hip stems.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized horizontal lines above a wavy line, resembling a stylized human figure.
Public Health Service
AUG - 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debra Bing Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401
Re: K031744 Trade/Device Name: Omnifit® HFx Hip Stem Series Regulation Number: 21 CFR 888.3350 and 21 CFR 888.3360 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis and Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: JDI, LWJ, and KWL Dated: June 4, 2003 Received: June 5, 2003
Dear Ms. Bing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Debra Bing
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia 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
510(k) Number (if known):
Device Name: Omnifit® HFx Hip Stem Series
The subject devices are intended for single use only, and may be used with or without bone cement. The subject devices may be used with an Howmedica Osteonics Endo Head and Neck Extension for hemi-hip arthroplasty, a UHR® Universal Head for bipolar hip replacement, or a Howmedica Osteonics C-Taper cobalt chromium head and Howmedica Osteonics acetabular component for conventional total hip arthroplasty.
Indications:
For use as a bipolar hip replacement
- Femoral head/neck fractures or non-union, .
- 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 acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum,
- . Salvage of failed total hip arthroplasty
- Femoral Neck Fractures .
For use as a total hip replacement
- Painful, disabling joint disease resulting from: degenerative arthritis, theumatoid arthritis, . post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other . procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
- Clinical circumstances that require an altered femoral resection level due to proximal fracture, . bone loss, or calcar lysis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| ------------------ | -- |
OR
| Over-The-Counter Use | (Per 21 CFR 801.109) | |
|---|---|---|
| ---------------------- | -- | ---------------------- |
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K031744 |
|---|---|
| --------------- | --------- |
TOTAL P.21