(86 days)
K97246J
Not Found
No
The document describes a hip stem implant and its intended use, focusing on mechanical design changes and equivalence to a predicate device. There is no mention of AI or ML technology in the description, intended use, or performance studies.
Yes
The device is intended for use in patients requiring hip replacement due to various painful and disabling joint diseases or injuries, aiming to alleviate symptoms and restore function.
No
This device is an Osteonics® Omnifit®-C Cemented Hip Stem, which is an implant used for hip replacement surgery. Its intended use is for treatment conditions like arthritis, not for diagnosing them.
No
The device description clearly states it is a physical hip stem, which is a hardware component.
No, 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 a physical implant (hip stem) used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical equivalence for surgical implantation, not diagnostic accuracy.
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 Osteonics® Omnifit®-C Cemented Hip Stems are intended for single-use in patients requiring hemi-hip replacement, bi-polar hip replacement, or total hip replacement. The Osteonics® Omnifit®-C Cemented Hip Stems are intended for cemented applications.
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.
Other considerations
- Pathological conditions or age considerations that indicate a more conservative . acetabular procedure and an avoidance of use of bone cement in the acetabulum.
- Salvage of a failed total hip arthroplasty. .
For use as a total hip replacement:
- 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.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
Product codes
JDI
Device Description
The modified Osteonics® Omnifit®-C Cemented Hip Stems have the same design as the predicate Osteonics® Omnifit®-C Cemented Hip Stems, except that the modified components feature a 5mm longer neck.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femoral head, acetabular
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)
No mechanical testing is required to demonstrate the substantial equivalence of the subject device to its predicate version. In effect, 5mm of offset have been shifted from the head side (in the case of the predicate device) to the stem side (in the case of the subject device). Therefore, the most severe predicate device combination remains equivalent to the most severe subject device combination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K97246J
Reference Device(s)
Not Found
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
K97246J
510(k) Summary
510(k) Summary Osteonics® Omnifit®-C Cemented Hip Stems
Submission Information
| Name and Address of the Sponsor: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|------------------------------------|------------------------------------------------------------------------------|
| Contact Person: | Terry Sheridan
Regulatory Affairs Specialist |
| Date of Summary Preparation: | June 30, 1997 |
| Device Identification | |
| Proprietary Name: | Osteonics® Omnifit®-C Cemented Hip
Stems (Line Extension) |
| Common Name: | Artificial hip joint component, femoral
stem |
| Classification Name and Reference: | Hip Joint Metal/Polymer
Semi-constrained Cemented Prosthesis
§888.3350 |
Predicate Device Identification
The subject Osteonics® Omnifit®-C Cemented Hip Stems are substantially equivalent to the predicate Osteonics® Omnifit®-C Cemented Hip Stems.
Device Description
The modified Osteonics® Omnifit®-C Cemented Hip Stems have the same design as the predicate Osteonics® Omnifit®-C Cemented Hip Stems, except that the modified components feature a 5mm longer neck.
Intended Use:
The Osteonics® Omnifit®-C Cemented Hip Stems are intended for single-use in patients requiring hemi-hip replacement, bi-polar hip replacement, or total hip replacement. The Osteonics® Omnifit®-C Cemented Hip Stems are intended for cemented applications.
1
1000 12000
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.
Other considerations
- Pathological conditions or age considerations that indicate a more conservative . acetabular procedure and an avoidance of use of bone cement in the acetabulum.
- Salvage of a failed total hip arthroplasty. .
For use as a total hip replacement:
- 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.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
Statement of Technological Comparison:
The subject Osteonics® Omnifit®-C Cemented Hip Stems are identical to the predicate Osteonics® Omnifit®-C Cemented Hip Stems except that the subject devices feature a neck length that is 5mm greater. This modification is non-significant, however, because the 5mm gained on the stem side have been compensated for by subtracting 5mm on the femoral head side (i.e., by contraindicating the modified stem for use with +10mm heads).
Performance Data:
No mechanical testing is required to demonstrate the substantial equivalence of the subject device to its predicate version. In effect, 5mm of offset have been shifted from the head side (in the case of the predicate device) to the stem side (in the case of the subject device). Therefore, the most severe predicate device combination remains equivalent to the most severe subject device combination.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terry Sheridan Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
SEP 2 5 397
K972460 Re: Osteonics® OmniFit®-C Cemented Hip Stems Trade Name: Regulatory Class: II Product Code: JDI Dated: June 30, 1997 Received: July 1, 1997
Dear Ms. Sheridan:
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. ದ 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 In addition, FDA may publish further announcements action. 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 requlations.
3
Paqe 2 - Ms. Terry Sheridan
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation (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 (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K972460
Device Name: Osteonics® Omnifit®-C Cemented Hip Stems
Indications For Use:
The Osteonics® Omnifit®-C Cemented Hip Stems are intended for single-use in patients requiring hemi-hip replacement, bi-polar hip replacement, or total hip replacement. The Osteonics® Omnifit®-C Cemented Hip Stems are intended for cemented applications.
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.
Other considerations
- Pathological conditions or age considerations that indicate a more conservative acetabular . procedure and an avoidance of use of bone cement in the acetabulum.
- Salvage of a failed total hip arthroplasty. .
For use as a total hip replacement:
- 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.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of Ceneral Restorative Devices 510(k) Number 19976460