(86 days)
The Howmedica Ostconics Radial Ilead Prosthosis is indicated for replacement of the proximal cond of the radius in cases of theumatoid arthritis; degenerative or posplacement di ine proximation disabilities ulper initial and decreased motion at the radio-humeral andination in the mainted ulnar joint involving joint destruction and/or subluxution visible on x-ray, resilence o conservative treatment; fracture of the radial head; and symptomatic sequela after radial head resection. It is also indicated for use in revision procedures following failed radial head arthroplasty. This device is intended for cemented use only .
The Howmedica Osteonics Radial Head Prosthesis is a highly polished unar bearing surface with a distal stem. The radial head prosthesis is available in a variety of sizes ranging from 8mm to 11mm small and 9mm to 15mm medium components.
The provided text describes a 510(k) premarket notification for the Howmedica Osteonics Radial Head Prosthesis. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, a study proving device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document.
The 510(k) summary explicitly states that the substantial equivalence is "based upon equivalence in intended use, materials, design, and operational principles" to previously cleared devices. This means that the device's performance is assumed to be equivalent to the predicate devices because its fundamental characteristics are similar, and clinical trials or performance studies with defined acceptance criteria are typically not required for this type of submission.
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JUL 2 7 2000
510(k) Summary
Device: Howmedica Osteonics Radial Head Prosthesis
The Howmedica Osteonics Radial Head Prosthesis is a highly polished unar bearing surface with a distal stem. The radial head prosthesis is available in a variety of sizes ranging from 8mm to 11mm small and 9mm to 15mm medium components.
The Howmedica Ostconics Radial Ilcad I'rosthesis is indicated for replacement of the proximal end of the radius in cases of rheumatoid arthritis; dogenerative or post-traumatic disabilities. presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radioulnar joint involving joint destruction and/or subluxation visible on x-ray; resistante to conservative treatment; fracture of the radial head; and symptomatic sequela after radial head resection. It is also indicated for use in revision procedures following failed ratial head arthroplasty. This device is intended for comented use only.
The radial head prosthesis will be fabricated from Vitallium® Alloy which complies to ASTM standard Ii 1537.
The substantial equivalence of the Howmedica Ostconics Radial Flead Prosthesis is based upon equivalence in intended use, materials, design, and operational principles to the Wrighto Modical Technology, Inc. Metallic Radial Head Implants (K944507), the Avanta Orthopacidia, Inc Radial Ilead Implant (K982288) and the Smith & Nophew, Inc. Radial Head Prosuless s (K992220).
For information contact:
Jennifor A. Daudelin Regulatory Affairs I lowmedica Ostconics Corp. 359 Veterans Boulevard Rutherford. NJ 07070 (201) 507-7283
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2000
Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics Corporation 359 Veterans Boulevard Rutherford, New Jersey 07070
Re: K001385
Trade Name: Howmedica Osteonics Radial Head Prosthesis Regulatory Class: II Product Code: KWI Dated: May 1, 2000 Received: May 2, 2000
Dear Ms. Daudelin:
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 control provisions of the Act. The general control 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 regulatory 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.
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.
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Page 2 - Ms. Jennifer A. Daudelin
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Danna R. Luchner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K001385
Device Name: Howmedica Osteonics Radial Head Prosthesis
Indications for Usc:
The Howmedica Ostconics Radial Ilead Prosthosis is indicated for replacement of the proximal cond of the radius in cases of theumatoid arthritis; degenerative or posplacement di ine proximation disabilities ulper initial and decreased motion at the radio-humeral andination in the mainted ulnar joint involving joint destruction and/or subluxution visible on x-ray, resilence o conservative treatment; fracture of the radial head; and symptomatic sequela after radial head resection. It is also indicated for use in revision procedures following failed radial head arthroplasty. This device is intended for cemented use only .
(PIALASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTILER PAGE IF
NUEDED NEEDED)
Concurrence of CDRIJ, Office of Device Evaluation (ODDL)
Prescription Use + (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Donna R. Lochner.
(Division Sign-Off)
Division of Cheral Restorative Devices 510(k) Number Kool 385
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.