WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS

K033112 · Hand Biomechanics Lab, Inc. · KTT · Nov 5, 2003 · Orthopedic

Device Facts

• Record ID: K033112
• Device Name: WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
• Applicant: Hand Biomechanics Lab, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Nov 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fracture reduction and external fixation for treatment of distal radius fractures.

Device Story

WristJack ORIF System is an external fixation device for distal radius fracture reduction and stabilization. System comprises an adjustable fixator frame, application instrumentation, and skeletal fixation pins. Used by surgeons in clinical settings to stabilize fractures. Fixator features a beam element with two carbon fiber rods; pins are implant-grade 316 stainless steel. Device provides mechanical support to maintain fracture alignment during healing. Delivered in sterile or non-sterile configurations; non-sterile units require user sterilization. Comparable to predicate in application technique and adjustment function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: polyetherimide resin, carbon fiber, stainless steel, titanium, aluminum alloy. Fixation pins: 316 stainless steel per ASTM F138. Design: adjustable external fixator frame with two carbon fiber rods. Connectivity: none. Sterilization: provided sterile or non-sterile (user-sterilized).

Indications for Use

Indicated for the reduction and external fixation of distal radius fractures in patients requiring such stabilization.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Agee WristJack Fracture Reduction System (K984442)

Submission Summary (Full Text)

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

# OV - 5 2003

Image /page/0/Picture/1 description: The image shows the logo for the Hand Biomechanics Lab. On the left side of the logo is a black silhouette of a hand with a curved line above it. To the right of the hand is the text "Hand Biomechanics Lab" stacked on top of each other. The text is in a simple, sans-serif font.

510(k) Summary

033112
page 1 of 1

Hand Biomechanics Lab. Inc. 77 Scripps Drive, Suite 104 Sacramento, CA 95825-6209 Contact: Timothy R. Stallings [phone] Phone: Fax: [phone] Email: [e-mail]

Prepared September 29, 2003

#### Name of Device:

| Regulatory Classification: | Class II |
|------------------------------|----------------------------------------------------------------------------------------------------|
| Classification Name: | Component, Traction, Invasive [888.3040] |
| Common Name: | External Fixator System |
| Trade Name/Proprietary Name: | WristJack ORIF System, Item No. CFD-347<br>WristJack ORIF System, non-sterile, Item No. CFD-347-NS |
| Performance Standards: | No performance standards exist for this device. |

#### Predicate Device:

Agee WristJack Fracture Reduction System (sterile), Item No. CFD-147, K984442

### Description of Device:

The WristJack ORIF System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction/fixation frame (fixator), application instrumentation and skeletal fixation pins.

The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, carbon fiber, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.

#### Intended Use:

Fracture reduction and external fixation for treatment of distal radius fractures.

#### Technological Characteristics Compared to Predicate Device:

The WristJack ORIF System is comparable to the predicate device with respect to application technique and adjustment function. The WristJack ORIF fixator has a beam element comprised of two carbon fiber rods compared to an injection molded Ultem component in the predicate device. The fixation pins and instrumentation are essentially identical to those included in the predicate device. The subject device is delivered to the customer in either sterile form. In the non-sterile model, the customer is responsible for sterilization before use. The predicate device is supplied sterile.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2003

Mr. Timothy R. Stallings Manufacturing Manager Hand Biomechanics Lab, Inc. 77 Scripps Drive, Suite 104 Sacramento, California 95825

Re: K033112

Trade/Device Name: WristJack ORIF System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 29, 2003 Received: September 30, 2003

Dear Mr. Stallings:

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.

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

Page 2 - Mr. Timothy R. Stallings

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Sincerely yours,

Mark N Millman

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

{3}------------------------------------------------

| 510(k) Number (if known): | K033112 |
|---------------------------|-----------------------|
| Device Name: | WristJack ORIF System |

Indications For Use:

Fracture reduction and external fixation for treatment of distal radius fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Mullener

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

510(k) Number K033112

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)