The Hoffmann® II Micro External Fixation System is intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

Device Description

This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Hoffmann® II Compact" External Fixation System. The subject device, named the Hoffmann® II Micro External Fixation System, is a line extension of the Hoffmann® II Compact External Fixation System. The predicate Hoffmann® II Compact External Fixation System is fabricated from stainless steel and aluminum. The subject Hoffmann® II Micro External Fixation System is fabricated from stainless steel. The Hoffmann® II Micro External Fixation System is a miniaturization of the Hoffmann® II Compact "External Fixation System. The miniaturization involves modifying the overall size of the components as well as reducing the size of the mating components (Apex® pins and connecting rods).

The subject Hoffmann® II Micro External Fixation System shares the same intended use, and basic design concepts as that of the currently available Hoffmann® II Compact™ External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain the information requested in your bullet points regarding acceptance criteria and the study that proves the device meets them.

The document focuses on:

Device Identification: Naming the device, its common name, and classification.
Device Description: Explaining that the Hoffmann® II Micro External Fixation System is a line extension of the Hoffmann® II Compact™ External Fixation System, miniaturized, and fabricated from stainless steel (whereas the predicate used stainless steel and aluminum).
Intended Use: Stating its purpose for stabilizing open and/or unstable fractures.
Substantial Equivalence: Confirming that mechanical testing demonstrated comparable mechanical properties to the predicate components, leading to FDA clearance.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, efficacy studies, sample sizes, expert involvement, or ground truth details, as this information is not present in the provided text.

The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate components." This is the extent of the "study" mentioned, aimed at proving substantial equivalence rather than defining and meeting specific acceptance criteria for performance in a clinical or diagnostic context.

Summary

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DEC 0 3 2001

Kol 3772
page 1 of 1

Summary of Safety and Effectiveness Line Extension to the Hoffmann® II Compact™External Fixation System

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

Contact Person:

59 Route 17 Allendale, NJ 07401-1677

Howmedica Osteonics Corp

Karen Ariemma Regulatory Affairs Specialist

Date of Summary Preparation:

November 8, 2001

Device Identification

Proprietary Name:	Hoffmann® II Micro External Fixation System(formerly the Hoffmann® II Compact™ ExternalFixation System)
Common Name:	External Fixation Frame Component
Classification Name and Reference:	Smooth or threaded metallic bone fixationfastener. 21 CFR §888.3040

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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 stylized eagle or bird symbol with three curved lines representing its wings or body. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CEC 0 3 2001

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401

Re: K013772

Trade/Device Name: Hoffman® II Micro External Fixation System Regulation Number: 888.3040, 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JEC, LXT

Dated: November 8, 2001 Received: November 13, 2001

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed 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 associated in the 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, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains 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 11 Jour device to such additional controls. Existing major regulations affecting your device can may or bagges to been an arraderal 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 r reaso or hour 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 or any I vith 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 Of It in the quality systems (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. Karen Ariemma

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 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 vours.

for Mark N Milliman

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): K Ol 377 x

Device Name: Hoffmann® II Micro External Fixation System (line extension to the Hoffmann® II Compact™ External Fixation )

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

KO134 42

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark N. Milliman

Division of General, Restorative and Neurological Devices

510(k) Number -

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.