(29 days)
This device is used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.
Titanium Compression Anchor System
The provided text is a 510(k) clearance letter from the FDA for a device called "Titanium Compression Anchor System". This document confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML device validation.
Therefore, I cannot extract the requested information from the provided text. The questions posed are relevant to AI/ML device submissions, which this document is not.
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Public Health Service
AUG 1 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Triage Medical, Inc. c/o Mr. Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606
Re: K012280
Trade Name: Titanium Compression Anchor System Regulation Number: 888.3040 Regulatory Class: II Product Code: HWC Dated: July 19, 2001 Received: July 19, 2001
Dear Mr. Holland:
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 - Mr. Greg Holland
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" (21CFR 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/dsma/dsmamain.html".
Sincerely vours.
Mark Mckesson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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Indications for Use Statement
Page_1_of_1
510(k) Number (if known): KO12280
Device Name: Titanium Compression Anchor System
Indications For Use:
This device is used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark H. Millenson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Prescripti0(k) Number
(Per 21 CFR 801.109)
K012280
OR
Over-The-Counter Use No
(Optional Format 1-2-96)
REGULATORY SPECIALISTS
§ 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.