K Number
K042761
Device Name
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
Manufacturer
Date Cleared
2004-11-17

(43 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wristore™* Distal Radius Fracture Fixator is indicated for external fixation of the upper extremity.
Device Description
The Wristore Distal Radius Fracture Fixator is a single use external fixator designed to provide stable fracture fixation. The lightweight, radiolucent construct incorporates self-drilling bone pins and K-wires to provide secure fracture fixation and to capture fracture fragments.
More Information

No
The summary describes a mechanical external fixator and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Yes.
The device is used for external fixation of the upper extremity, which is a therapeutic intervention for fractures.

No

The device is described as a "Distal Radius Fracture Fixator" designed for "external fixation of the upper extremity" and to "provide stable fracture fixation and to capture fracture fragments." Its purpose is to stabilize and fix fractures, not to diagnose medical conditions or identify diseases.

No

The device description clearly states it is an "external fixator" and incorporates "bone pins and K-wires," which are physical hardware components.

Based on the provided information, the Wristore™ Distal Radius Fracture Fixator is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "external fixation of the upper extremity," specifically for "stable fracture fixation." This is a therapeutic and structural function, not a diagnostic one performed on samples taken from the body.
  • Device Description: The description details a physical device used to stabilize bone fractures. It involves bone pins and K-wires, which are implanted into the body. This is characteristic of a surgical or orthopedic device, not an IVD.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening

In summary, the Wristore™ Distal Radius Fracture Fixator is a medical device used for treating fractures, not for performing diagnostic tests on in vitro samples.

N/A

Intended Use / Indications for Use

The Wristore™* Distal Radius Fracture Fixator is indicated for external fixation of the upper extremity.

Product codes

KTT

Device Description

The Wristore Distal Radius Fracture Fixator is a single use external fixator designed to provide stable fracture fixation. The lightweight, radiolucent construct incorporates self-drilling bone pins and K-wires to provide secure fracture fixation and to capture fracture fragments.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper extremity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.

Key Metrics

Not Found

Predicate Device(s)

Millennium Medical Technologies, Inc., Wristore Fixator, K012294, Immedica, Inc, TransFx Self-Drilling External Fixation Anchor Pin, K001228

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

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

0

Image /page/0/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a sans-serif font. The logo is black and white.

Traditional 510(k) Premarket Notification

NOV 1 7 2004Summary of Safety and Effectiveness
Submitter:Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Contact Person:Noah Bartsch
Specialist, Corporate Regulatory Affairs
Telephone: (574) 371-8552
Fax: (574) 372-4605
Date:10-04-2004
Trade Name:Wristore™* Distal Radius Fracture Fixator
Common Name:External Fixator
Classification Name:Smooth or threaded metallic bone fixation fastener
Single/multiple component metallic bone fixation
appliances and accessories
Classification Reference:21 CFR § 888.3040, 3030
Predicate Devices:Millennium Medical Technologies, Inc., Wristore
Fixator, K012294, cleared March 4, 2002
Immedica, Inc, TransFx Self-Drilling External
Fixation Anchor Pin, K001228, cleared July 7, 2000
Device Description:The Wristore Distal Radius Fracture Fixator is a
single use external fixator designed to provide
stable fracture fixation. The lightweight,
radiolucent construct incorporates self-drilling bone
pins and K-wires to provide secure fracture fixation
and to capture fracture fragments.
Intended Use:The Wristore Distal Radius Fracture Fixator is
indicated for external fixation of the upper
extremity.
Comparison to Predicate Device:The Wristore Distal Radius Fracture Fixator has the
same intended use, has similar performance
characteristics, is manufactured from similar
materials using similar processes, and is similar in
design to the predicate devices.
Performance Data:The results of non-clinical (laboratory) performance
testing demonstrate that the device is safe and
effective.
  • Trademark of Millennium Medical Technologies, Inc.

1

Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a stylized "Z" inside of a circle, followed by the word "zimmer" in a bold, sans-serif font. The "Z" in the circle is black, and the word "zimmer" is also black.

*Trademark of Millennium Medical Technologies, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2004

Mr. Noah Bartsch Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581

Re: K042761

Trade/Device Name: Wristore™ Distal Radius Fracture Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 4, 2004 Received: October 5, 2004

Dear Mr. Bartsch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered pror to rias 2011-11-11 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 r ou may) ater see or visions 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 If your de ree 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2 - Mr. Noah Bartsch

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with a a your e FDA finding of substantial equivalence of your device to a legally premailed predicated 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. Mark H. Mellum

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

4

Indications for Use

510(k) Number (if known):

Device Name:

Wristore™* Distal Radius Fracture Fixator

*Trademark of Millennium Medical Technologies, Inc.

Indications for Use:

The Wristore™* Distal Radius Fracture Fixator is indicated for external fixation of the upper extremity.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Ot7)

Division of General, Restorative, and Neurological Devices

510(k) Number K042761