(90 days)
No
The summary describes a mechanical orthopedic implant and does not mention any AI or ML components or functionalities.
Yes
The device is intended for implantation during arthroplasty surgery to treat various hip joint conditions, restore patient mobility, and address previously failed surgeries, all of which align with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is an implantable medical device (bipolar cup for hip replacement) used during surgery, not for diagnosing conditions. Its purpose is to restore mobility by articulating with the acetabulum and femoral stem.
No
The device description and intended use clearly describe a physical implant (bipolar cup) used in hip surgery, not a software application.
Based on the provided information, the ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "single-use cementless implantation during primary or revision arthroplasty surgery." This describes a surgical implant used in the body, not a device used to examine specimens outside the body.
- Indications for Use: The indications are for various conditions affecting the hip joint, requiring surgical intervention. This aligns with a surgical implant, not a diagnostic test.
- Anatomical Site: The anatomical site is the "hip joint," which is an internal part of the body.
- Intended User / Care Setting: The intended user is involved in "arthroplasty surgery," which is a surgical procedure.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The ODC™ B2 Bipolar Cup is a prosthetic implant used to replace a damaged hip joint.
N/A
Intended Use / Indications for Use
The ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is intended for single-use cementless implantation during primary or revision arthroplasty surgery. The bipolar cup allows for primary articulation between the acetabulum and femoral stem to restore patient mobility. Indications for use are:
- . Osteoarthritis, theumatoid arthritis, or other osteoarthrosis of the hip joint;
- Certain femoral neck fractures or dislocations; .
- Post-traumatic arthritis; .
- Idiopathic avascular necrosis of the femoral head; ●
- Benign or malignant bone tumors where sufficient bone stock exists to seat the . prosthesis:
- Previously failed surgery ●
The ODC™ B2 Bipolar Cup may be used with the Primaloc™ Cementless Hip System, which is cleared for use under Premarket Notification K953977.
Product codes
KWY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, acetabulum, femoral stem, femoral head
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/10 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUM / SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH & HUM". In the center of the seal is a stylized caduceus symbol, which is often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 1998
Ms. Carol Freasier Manager, Requlatory Affairs/QA Ortho Development Corporation 106 West Business Park Drive Draper, Utah 84020
K982389 Re: ODC™ B2 Bipolar Cup Trade Name: Regulatory Class: II Product Code: KWY Dated: July 7, 1998 Received: July 9, 1998
Dear Ms. Freasier:
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 requlatory 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.
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Page 2 - Ms. Carol Freasier
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 leqally 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 (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
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510(k) Number (if known): K982389
Device Name: ODC™ B2 Bipolar Cup
Indications for Use
The ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is intended for single-use cementless implantation during primary or revision arthroplasty surgery. The bipolar cup allows for primary articulation between the acetabulum and femoral stem to restore patient mobility. Indications for use are:
- . Osteoarthritis, theumatoid arthritis, or other osteoarthrosis of the hip joint;
- Certain femoral neck fractures or dislocations; .
- Post-traumatic arthritis; .
- Idiopathic avascular necrosis of the femoral head; ●
- Benign or malignant bone tumors where sufficient bone stock exists to seat the . prosthesis:
- Previously failed surgery ●
The ODC™ B2 Bipolar Cup may be used with the Primaloc™ Cementless Hip System, which is cleared for use under Premarket Notification K953977.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
broeefo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982389
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)