HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED

K012817 · Triage Medical, Inc. · HWC · Nov 20, 2001 · Orthopedic

Device Facts

• Record ID: K012817
• Device Name: HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
• Applicant: Triage Medical, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used in general management of fractures and reconstructive surgery.

Device Story

Helical Compression Anchor, non-cannulated; metallic bone fixation fastener. Used for fracture management and reconstructive surgery. Implanted by surgeons in clinical settings to provide mechanical fixation of bone segments. Device design facilitates compression across fracture sites or osteotomies. Provides structural stability to support bone healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; non-cannulated helical compression design. Classified under 21 CFR 888.3040, Product Code HWC.

Indications for Use

Indicated for patients requiring general fracture management and reconstructive surgery.

Regulatory Classification

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.

Submission Summary (Full Text)

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Greg Holland Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, CA 92606

NOV 2 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K012817

Trade/Device Name: Triage Medical, Inc. Helical Compression Anchor, non-cannulated Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 21, 2001 Received: August 22, 2001

Dear Mr. Holland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 forth 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 - Mr. Holland

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mala M. Millerson

Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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NOV 2 0 2001

Indications for Use Statement

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510(k) Number (if known):_K012817

Device Name:Helical Compression Anchor, Non-cannulated

Indications For Use:

This device is used in general management of fractures and reconstructive surgery.

(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

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

Over-Number
(Optional Format 1-2-96)
K012817

REGULATORY SPECIALISTS