Stabilization of open and/or unstable fractures of the distal radius, where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.

Device Description

The device is an external wrist fixator made of radiolucent polymer, polycarbonate. The fixator is a non-bridging device, which means that it does not cross the wrist. A non-bridging device gives patients the ability to utilize wrist function.

The device consists of two plates with multiple pin holes. Pins are inserted through the plates, into the bone and held in place by the interference of the two plates. The plate has an external bracket that allows pins to be inserted from the side for additional fixation. If desired, distraction of the fracture site may be achieved with adjustment of a threaded pin placed within a slot on the distal end of the plate.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the NBX - Non-Bridging External Fixator. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving the device meets specific acceptance criteria through clinical or analytical performance testing.

Therefore, the specific information requested in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not available in this document.

Here's why:

The document states under "Clinical Testing: None provided."
The primary purpose of a 510(k) submission for this type of device is often to demonstrate substantial equivalence through technological characteristics and non-clinical (mechanical) testing, as indicated by "Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not effect the safety of the device."

Without clinical testing or detailed analytical performance studies, there are no acceptance criteria, reported device performance metrics, or study designs to describe in the way your prompt expects.

Summary

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APR 1 5 2002

K020905
page 1 of 1

ARTERS CORPORATE

Summary of Safety and Effectiveness

Applicant/Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Patricia Sandhorn Beres

Senior Regulatory Specialist Phone: (574) 267-6639

Proprietary Name: NBX - Non-Bridging External Fixator

Common Name: External Fixator

Classification Name: Single/Multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030)

Legally Marketed Device to which Substantial Equivalence is Claimed: Biomet External Wrist Plate (K003240)

Device Description: The device is an external wrist fixator made of radiolucent polymer, polycarbonate. The fixator is a non-bridging device, which means that it does not cross the wrist. A non-bridging device gives patients the ability to utilize wrist function.

Intended Use: Stabilization of open and/or unstable fractures of the distal radius, where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.

Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the NBX – Non-Bridging External Fixator are similar to or identical to the predicate device.

Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not effect the safety of the device.

Clinical Testing: None provided

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

ドヘX 219.267.8137

E-MAH biomet@biomet.com

00081

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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 is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2002

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K020905

Trade/Device Name: NBX-Non-Bridging External Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories.

Regulatory Class: II Product Code: LXT Dated: March 19, 2002 Received: March 20, 2002

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device wone reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are and and 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 - Ms. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your Section 510(k) I mir letter hititication. 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 (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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

for Mark n Millican

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): K020905

Device Name: NBX - Non-Bridging External Fixator

Indications For Use:

for Mark n Millkerson

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

KO20905 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

000005

Regulation Number and Section

§ 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.