HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2

K013903 · Triad Medical, Inc. · HWC · Dec 17, 2001 · Orthopedic

Device Facts

• Record ID: K013903
• Device Name: HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
• Applicant: Triad Medical, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 17, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Helical Compression Anchor System, Cannulated, Version 2 is a metallic bone fixation fastener. Used by surgeons in clinical settings for fracture management and reconstructive procedures. Device provides mechanical stabilization of bone segments to facilitate healing. Operates as a traditional orthopedic fixation fastener.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; cannulated design; classified under 21 CFR 888.3040 (Product Code HWC).

Indications for Use

Indicated for patients requiring general management of fractures 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 7 200i

Triage Medical Inc. c/o Ms. Rita Giebel Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, California 92606

Re: K013903

Trade/Device Name: Helical Compression Anchor System, Cannulated, Version 2 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 21, 2001 Received: November 26, 2001

Dear Ms. Giebel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 20, 1978, ins cassordance with the provisions of the Federal Food, Drug, de noos mat hat o been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, increrere, mailes 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 rr your device to such additional controls. Existing major regulations affecting your device can may or babyer to back as a succeral 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 r toase of acrised alat i sermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 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 - Ms. Rita Giebel

This letter will allow you to begin marketing your device as described in your fection 510(k) This letter will anow you is cegain mailing of substantial equivalence of your device to a legally premarket notification: "The PDF intelling of easification 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 IT you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CHC Fat 00710 Idditionally, for questions on the promotion and advertising of Compliance at [phone]. The may at [phone]. Also, please note the your do roo, produce combranding by reference to premarket notification" (21CFR Part 807.97). Tegulation entitled, "Misorananing of responsibilities under the Act may be obtained from the Other general information on your respectional 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,

f
Celia M. Witten, Ph.D., M.D.

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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## Indications for Use Statement

Page 1 of 1

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K013903 |

Device Name: Helical Compression Anchor System, Cannulated, Version 2

Indications for Use:

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

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

510(k) Number K013903

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

REGULATORY SPECIALISTS

Pagc I l