WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS

K030519 · Hand Biomechanics Lab, Inc. · JEC · Jun 10, 2003 · Orthopedic

Device Facts

• Record ID: K030519
• Device Name: WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
• Applicant: Hand Biomechanics Lab, Inc.
• Product Code: JEC · Orthopedic
• Decision Date: Jun 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The WristJack System is an external fixation device used for the reduction and stabilization of distal radius fractures. The system consists of an adjustable reduction frame (fixator), application instrumentation, and skeletal fixation pins. It is used by clinicians in a clinical setting to mechanically stabilize fractures. The device is reprocessed from the predicate Agee WristJack system. It is provided in either sterile or non-sterile configurations, with the non-sterile version requiring user sterilization prior to application. The device provides mechanical support to the bone during the healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of polyetherimide resin, stainless steel, titanium, and aluminum alloy. Fixation pins are implant-grade 316 stainless steel per ASTM F138. The device is a mechanical external fixator system with adjustable frame components. No software or electronic components.

Indications for Use

Indicated for patients requiring fracture reduction and external fixation for the treatment of distal radius 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.

Predicate Devices

• Agee WristJack Fracture Reduction System (K984442)

Submission Summary (Full Text)

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JUN 1 0 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", with each word on a separate line. The text is in a simple, sans-serif font.

510(k) Summary

030519
page 1 of 1

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

Prepared February 18, 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 System (remanufactured), sterile, Item No. CFD-147-RS<br>WristJack System (remanufactured), non-sterile, Item No. CFD-147-RNS |
| 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 System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction 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, 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:

All device components and materials of the WristJack System (remanufactured) are identical to the device components and materials of the predicate device. The subject device is reprocessed and 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2003

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

Re: K030519

Trade/Device Name: WristJack System (remanufactured) sterile and non-sterile Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JEC Dated: May 23, 2003 Received: May 29, 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.

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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]. 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,

Miriam C. Provost

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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510(k) Number (if known): _KO30519 Device Name: WristJack System (remanufactured) _______________________________________________________________________________________________________________________________ Indications For Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K030579

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)