(63 days)
No
The summary describes a physical implant (polyethylene cup) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a component for total hip arthroplasty, which is a surgical procedure to restore joint function and alleviate pain, thus providing therapeutic benefit.
No
This device is an implantable medical device (acetabular component) used in total hip arthroplasty to replace the bearing portion of the acetabulum, not to diagnose a condition. Its function is treatment/replacement, not diagnosis.
No
The device description clearly states it is a physical polyethylene cup, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty." This is a surgical implant used in vivo (within the body) during a medical procedure.
- Device Description: The description details a physical component (a polyethylene cup) designed to be surgically implanted and cemented into the acetabulum.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for medical conditions. This device is a prosthetic implant used for surgical reconstruction.
N/A
Intended Use / Indications for Use
The Contemporary Acetabular Component is intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This component is designed to be cemented into the acetabulum.
Product codes
JDI
Device Description
The Contemporary Acetabular Component is a polyethylene cup that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is designed to be cemented into the acetabulum.
The Contemporary Acetabular Component is available in outer diameters of 38 to 80mm in two millimeter increments. These cups are manufactured from Ultra High Molecular Weight Polyethylene which conforms to ASTM F-648.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabulum (hip)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
OCT 2 1998
Proprietary Name: Contemporary Acetabular Component
Common Name: All Polyethelene Acetabular Cup
Classification Name and Reference: CFR 888.3350 This device is a component of a hip joint, metal/polymer, semiconstrained cemented prosthesis.
Proposed Regulatory Class: Class II
Device Product Code: OR(87) JDI
Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 7/31/98
The Contemporary Acetabular Component is a polyethylene cup that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is designed to be cemented into the acetabulum.
The Contemporary Acetabular Component is available in outer diameters of 38 to 80mm in two millimeter increments. These cups are manufactured from Ultra High Molecular Weight Polyethylene which conforms to ASTM F-648.
The substantial equivalence of the Contemporary Acetabular Component is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Premise All Polyethylene Cup (K912426) and Johnson & Johnson's Ultima™ All Polyethylene Cup (K924115).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 OCT
Mr. Frank Maas Manager, Requlatory Affairs Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K982670 Re: Trade Name: Contemporary Acetabular Component Regulatory Class: II Product Code: JDI Dated: July 31, 1998 Received: July 31, 1998
Dear Mr. Maas:
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 qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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. ಗಿ 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.
2
Page 2 - Mr. Frank Maas
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colva M. Witton, Ph.D., M.I.
Cella M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K982670
Device Name: Contemporary Acetabular Component
Indications for Use:
The Contemporary Acetabular Component is intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This component is designed to be cemented into the acetabulum.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use your (Per 21 CFR 801.109)
OR
Over-The-Counter Use N/o
(Optional Format 1-2-96)
(Division Sign-Off)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number R982670