HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM

K022647 · Triad Medical, Inc. · HWC · Sep 5, 2002 · Orthopedic

Device Facts

• Record ID: K022647
• Device Name: HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
• Applicant: Triad Medical, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 5, 2002
• 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, 7.3mm is a metallic bone fixation fastener. Used by surgeons in clinical settings for fracture management and reconstructive surgery. Device provides mechanical stabilization of bone segments to facilitate healing. Operates as a traditional orthopedic implant; no software or electronic components involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation fastener; cannulated design; 7.3mm diameter. Class II device under 21 CFR 888.3040.

Indications for Use

Indicated for general management of fractures and reconstructive surgery in patients requiring bone fixation.

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

5 2002 SEP

Mr. Brad Culbert Vice President of Engineering Triage Medical, Inc. 13700 Alton Parkway, Suit 167 Irvine, California 92618

Re: K022647

Trade/Device Name: Helical Compression Anchor System, Cannulated, Model 7.3mm Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 9, 2002 Received: August 9, 2002

Dear Mr. Culbert :

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. Brad Culbert

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,

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

510(k) Number (if known): K022647

Device Name: Helical Compression Anchor System, Cannulated, 7.3mm

Indications for Use:

This device is used in the 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)


(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| Prescription Use | <p>Yes</p> |
|----------------------|------------|
| (Per 21 CFR 801.109) | |

| 510(k) Number | K022647 |
|---------------|--------------------------|
| | Over-The-Counter Use No |
| | (Optional Format 1-2-96) |

Triage Medical