The Agee-WristJack 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, stainless steel and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.

AI/ML Overview

The provided text is a 510(k) summary for the Agee-WristJack Fracture Reduction System (sterile version). It mainly focuses on demonstrating substantial equivalence to a predicate device by highlighting that the only difference is the sterility of the new device.

Therefore, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other details related to a performance study for this specific device.

The document states:

"All the device components and materials of the Agee-WristJack Fracture Reduction System (sterile version) are identical to the device components and materials of the predicate device, except this device is delivered sterile. The predicate device requires customer sterilization prior to use."
"No performance standards exist for this device."

This indicates that the submission relies on the established safety and effectiveness of the non-sterile predicate device, with the sterile aspect being the primary change, likely supported by sterilization validation studies, not clinical performance studies comparing the new device's efficacy.

Summary

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2/12/99

Image /page/0/Picture/1 description: The image shows the logo for Hand Biomechanics Lab, Inc. On the left side of the logo is a black silhouette of a hand with a curved line around it. To the right of the hand is the word "HAND" in large, bold, black letters, with the words "BIOMECHANICS" underneath it. Below that is a black line with the words "LAB, INC." in white letters.

K982)44.2

510(k) Summary

Hand Biomechanics Lab. Inc. 77 Scripps Drive, Suite 104 Sacramento, CA 95825-6209

Contact: Timothy R. Stallings Phone: (916) 923-5073 Fax: (916) 920-2215 Email: trstallings@handbiolab.com

Name of Device:

Regulatory Classification: Classification Name: Common Name: Trade Name/Proprietary Name:

Class II Component, Traction, Invasive [888.3040] External Fixator System Agee-WristJack Fracture Reduction System (sterile version), Item No. CFD-147 No performance standards exist for this device.

Performance Standards:

Predicate Device:

Agee-WristJack Fracture Reduction System (non-sterile version), Item No. CFD-47, K842493

Description of Device:

Intended Use:

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

Technological Characteristics Compared to Predicate Device:

All the device components and materials of the Agee-WristJack Fracture Reduction System (sterile version) are identical to the device components and materials of the predicate device, except this device is delivered sterile. The predicate device requires customer sterilization prior to use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

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

Re: K984442 Agee-WristJack Fracture Reduction System (sterile version), Item No. CFD-147 Regulatory Class: II Product Code: JEC Dated: December 11, 1998 December 14, 1998 Received:

Dear Mr. Stallings:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Timothy R. Stallings

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_

Agee-WristJack Fracture Reduction System (sterile versions) Device Name:_

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)

P. O'Leary

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K984442

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.