(90 days)
This device is indicated for use in the general management of fractures and reconstructive surgery in non-weight bearing applications with proper postoperative immobililzation.
Bone-Lok™ Bioabsorbable Compression Anchor with Titanium Fixture and Bone-Lok™ Bioabsorbable Compression Anchor
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the Bone-Lok™ Bioabsorbable Compression Anchor, indicating that the device is substantially equivalent to legally marketed predicate devices.
The letter discusses regulatory aspects, such as compliance with the Federal Food, Drug, and Cosmetic Act, and general controls like good manufacturing practice and labeling. However, it does not detail specific performance characteristics, acceptance criteria, or any studies undertaken to demonstrate the device's efficacy or safety in relation to such criteria. The "Indications For Use" section merely states the general purpose of the device.
Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance or information about a study based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD. 20850
MAR 2 7 2002
Mr. Brad Culbert Vice President, Engineering Research and Development Triage Medical, Inc. 13700 Alton Parkway Suite 167 Irvine, Calfornia 92618
Rel K014243 and K014304
Rol4243and Ro1 1501
Trade/Device Name: Bone-Lok™ Bioabsorbable Compression Anchor with Titanium Fixture and Bone-Lok™ Bioabsorbable Compression Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC Dated: December 21 and December 28, 2001 Received: December 26 and December 31, 2001
Dear Mr. Culbert:
We have reviewed your Section 510(k) premarket notification of intent to market the devices we nave reviewed your books on the devices are 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 meersate commored price to that have been reclassified in accordance with the provisious of the Amendinents, of to devroos marker Act (Act) that do not require approval of a premarket approval rodolar Pood, Drag, and may, therefore, market the devices, subject to the general controls appireation (1 Mr ); Fou may ; meresent controls provisions of the Act include requirements for annual provisions of the rot: "The general smanufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting (1 writ), may of be bacycle of Federal Regulations, Title 21, Parts 800 to 898. In your devices can or realish further announcements concerning your devices in the Federal Register.
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Page 2 - Mr. Brad Culbert
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fut 007); adoling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision of Small Manufacturers, International 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 McMillan
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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Page
510(k) Number (if known): K014243
Device Name: Bone-Lok™ bioabsorbable Compression Anchor with Titanium Fixture
Indications For Use:
This device is indicated for use in the general management of fractures and reconstructive surgery in non-weight bearing applications with proper postoperative immobililzation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliken
1 11/10/1010 Sign-Off) Division of General, Restorative and Neur logical Devices
Kol4243 510(k) Number_
(Optional Format 3-10-98)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.