(63 days)
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.
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 provided text is a 510(k) summary for the Contemporary Acetabular Component, a medical device for hip replacement. It outlines the device description, intended use, and claims of substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets said criteria, as is common for many 510(k) submissions that rely on predicate device equivalence.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating equivalence, not on specific performance acceptance criteria or a study proving those criteria were met for this particular device.
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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).
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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.
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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
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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.
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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
§ 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.