HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX

K012818 · Triage Medical, Inc. · HWC · Nov 20, 2001 · Orthopedic

Device Facts

• Record ID: K012818
• Device Name: HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
• 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

These devices are used for the correction of hallux valgus (bunion) and repair of metatarsal, metacarpal and phalangeal fractures.

Device Story

Helical Compression Anchor, Cannulated (Single/Double Helix) is a metallic bone fixation fastener. Used by orthopedic surgeons for bone stabilization in foot and hand surgery. Device provides mechanical compression across fracture sites or osteotomies to facilitate healing. Cannulated design allows for placement over guidewire. Operates as a mechanical implant; no software or electronic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; cannulated design; single or double helix configuration. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for patients requiring correction of hallux valgus (bunion) or repair of metatarsal, metacarpal, and phalangeal fractures.

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)

{0}------------------------------------------------

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 & Human Services. The logo features a stylized image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

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

## Re: K012818

Trade/Device Name: Triage Medical, Inc. Helical Compression Anchor, 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.

{1}------------------------------------------------

## 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 yours,

Mark A. Milkener

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

{2}------------------------------------------------

## NOV 2 0 2001

Indications for Use Statement

Page 1_of _1

510(k) Number (if known): K012818

Device Name:Helical Compression Anchor, Cannulated, Single and Double Helix

Indications For Use:

These devices are 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) | |
|--------------------------------------------------------|------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |
| | K012818 |
| Prescription Use | OR 510(k) Number Over-The-Counter Use |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |