(70 days)
The Radiographic Markers are intended for implantation in the bone to aid the surgeon in radiographic assessment of total hip or knee component movement.
The Radiographic Markers are spherical in shape and available in 00.8-1.0 mm. The Radiographio hauters antalum conforming to the composition called out in ASTM F560-98.
The provided text is a 510(k) summary for a medical device (Radiographic Markers) and does not contain a study demonstrating the device meets acceptance criteria. The document states that the device is substantially equivalent to a predicate device based on comparable materials, design, and indications for use. Therefore, I cannot provide the requested information.
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AUG 2 2 2001
Summary of Safety and Effectiveness
K011856
Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500
Trade Name: Radiographic Markers
Classification Name: Marker, radiographic, implantable
Description: The Radiographic Markers are spherical in shape and available in 00.8-1.0 mm. Description: The Radiographio hauters antalum conforming to the composition called out in ASTM F560-98.
Intended Use: The Radiographic Markers are intended for implantation in the bone to aid the surgeon in radiographic assessment of total hip or knee component movement.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include comparaterials, design and indications as the Biomet Tantalum Beads (K010348).
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
AUG 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Joanne Droege Regulatory/Quality Assurance Engineer Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
Re: K011856
Trade/Device Name: Radiographic Markers Regulation Number: 878.4300 Regulatory Class: II Product Code: NEU, FZP Dated: June 11, 2001 Received: June 13, 2001
Dear Ms. Droege:
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 legally marketed predicate 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 requirements, 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.
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Page 2 - Ms. Joanne Droege
This letter will allow you to begin marketing your device as described in your 510kk) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Dr Imanig of easing of easing 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 If you desire specific acvice for your actic devices), please contact the Office of Compliance at additionally 609.10 for in Thio diagnestions on the promotion and advertising of your device, (201) 594-4639. Rudinonary, 10. quise at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and its toll-free number (800) 638-2041 or 1911) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
for Mark N. Mellausen
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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56
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Radiographic Marker Indications For Use
The Radiographic Markers are intended for implantation in the bone to aid the The Radiographic Markers assument of total hip or knee component movement. Surgeon in Tachographic assessmanufactured from inert, biocompatible materials.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)_
Mark A Milkers
(Division Sign-Off) (Division of General, Restorative and Neurological Devices 011856
510(k) Number -
SK23
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.