(88 days)
The Modular Radial Head Replacement Device is intended for:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
a) Joint destruction and/or subluxation visible on x-ray
b) Resistance to conservative treatment - Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty
The device is intended for single use with bone cement.
The Modular Radial Head Replacement Device is a two-piece prosthesis consisting of a stem (Ti-6Al-4V) and a head (Co-Cr-Mo). The tapered stem is cemented into the intramedullary canal of the radius. The head has a highly polished concave surface to articulate with the natural bone of the humerus and ulna. The proximal portion of the stems are roughened with a Bond Coat surface. The components connect via a dove-tail joint secured by a locking screw. The device is available in three diameters, 18mm, 20mm and 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) premarket notification for a medical device (Modular Radial Head Replacement Device).
Here's what the document indicates:
- Non-Clinical Testing and Clinical Testing: The document explicitly states "none provided as a basis of substantial equivalence." This means no new testing was submitted to demonstrate the device's performance against specific acceptance criteria.
- Substantial Equivalence: The FDA's letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway relies on demonstrating that the new device is as safe and effective as a legally marketed device that is already on the market, rather than requiring new performance studies against predefined acceptance criteria.
Therefore, since no study was conducted or reported in this document to demonstrate performance against acceptance criteria, most of the requested information cannot be extracted.
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JUN 0 4 2004
BIOMET
Summary of Safety and Effectiveness
Biomet Manufacturing Corp. Applicant/Sponsor: 56 Bell East Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Contact Person: Patricia Sandborn Beres Telephone: (574) 267-6639
Proprietary Name: Modular Radial Head Replacement Device
Common Name: Elbow hemi-prosthesis
Classification Name: Elbow joint radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170)
Legally Marketed Devices to Which Substantial Equivalence Is Claimed: Liverpool Radial Head Replacement Device (K012551), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Modular Radial Head (Wright Medical Tech. Inc., K991915)
Device Description: The Modular Radial Head Replacement Device is a two-piece prosthesis consisting of a stem (Ti-6Al-4V) and a head (Co-Cr-Mo). The tapered stem is cemented into the intramedullary canal of the radius. The head has a highly polished concave surface to articulate with the natural bone of the humerus and ulna. The proximal portion of the stems are roughened with a Bond Coat surface. The components connect via a dove-tail joint secured by a locking screw. The device is available in three diameters, 18mm, 20mm and 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.
Intended Use: The Modular Radial Head Replacement Device is intended for:
-
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a) Joint destruction and/or subluxation visible on x-ray
- b) Resistance to conservative treatment
-
- Primary replacement after fracture of the radial head
-
- Symptomatic sequelae after radial head resection
-
- Revision following failed radial head arthroplasty
The device is intended for single use with bone cement.
Summary of Technologies: The technological characteristics (materials, design, sizing, and indications) of the Modular Radial Head Replacement Device are similar to or identical to the predicate devices.
Non-Clinical Testing and Clinical Testing: none provided as a basis of substantial equivalence
MAILING ADDRESS PO. Box 587 Warsaw, IN 46581-0587
E
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
E
()FFICE 574.267.6639
FAX 574.267.8137 83
E MAII. biomet@biomet.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 4 2004
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K040611
Trade/Device Name: Modular Radial Head Replacement Device Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Codc: KWI Dated: March 5, 2004 Received: March 8, 2004
Dear Ms. Sandborn Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviously of a became in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use mated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conner of the reserved in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diererery mains 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 (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may or subject to basil advanced Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I fease of actived a determination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must of any i edotar statutes and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Patricia Sandborn Beres
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher wif anow you're ough finding of substantial equivalence of your device to a legally prematication. The PDF Amazingssification 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), please If you desire specific acrioliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Melkerson
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):
Modular Radial Head Replacement Device Device Name:
Indications For Use: The Modular Radial Head Replacement Device is intended for:
-
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a) Joint destruction and/or subluxation visible on x-ray
- Resistance to conservative treatment b)
-
- Primary replacement after fracture of the radial head
-
- Symptomatic sequelae after radial head resection
-
- Revision following failed radial head arthroplasty
The device is intended for single use with bone cement.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Millheim
Division of General, Restorative, and Neurological Devices
KO40611 510(k) Number.
Page 1 of 1
§ 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.