The Hoffmann ® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:

Bone fracture fixation .
. Osteotomy
Arthrodesis .
Correction of deformity .
Revision procedure where other treatments or devices have been unsuccessful .
Non-unions and delayed unions .
Compression/distraction and lengthening .

Device Description

This line extension is to modify the lengthener components to the Hoffmann® II Micro™ External Fixation System. This component is an external fixation frame component and can be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® II Micro " External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact" External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax "External Fixation System.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Hoffmann® II Micro™ Lengthener Line Extension." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Instead, the document details:

The device's proprietary and common name.
Its classification and product code.
Contact information for the manufacturer.
A brief description of the device as a line extension to modify lengthener components for external fixation systems.
The intended use of the Hoffmann® II Micro™ External Fixation System, which includes stabilization of fractures, osteotomy, arthrodesis, correction of deformity, revision procedures, non-unions, delayed unions, and compression/distraction and lengthening.
A statement of substantial equivalence to predicate devices based on intended use, materials, design, and mechanical performance.
A letter from the FDA confirming the 510(k) clearance based on substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from the provided text. This type of submission relies on demonstrating similarity to existing, legally marketed devices rather than presenting new performance data against specific acceptance criteria.

Summary

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AUG 5 - 2005

Special 510(k)

510(k) Summary of Safety and Effectiveness for the Hoffmann® II Micro™ Lengthener Line Extension

Proprietary Name:	Hoffmann® II Micro™ External Fixation System
Common Name:	External Fixation Frame Components
Classification Name and Reference	Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030
Device Product Code:	87 KTT
For Information contact:	Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581Fax: (201) 831-6038
Date Summary Prepared:	July 28, 2005

Description:

Intended Use:

The Hoffmann® II Micro" External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:

Bone fracture fixation .
Osteotomy .
Arthrodesis
. Correction of deformity
Revision procedure where other treatments or devices have been unsuccessful .
Non-unions and delayed unions .
. Compression/distraction and lengthening

Substantial Equivalence:

Equivalency is based on similarities in intended use, materials and design to the predicate devices and the mechanical performance demonstrating substantial equivalence to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other, with 'Public' on the top line, 'Health' on the second line, and 'Service' on the bottom line.

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right and is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

AUG 5 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K052037 Trade/Device Name: Hoffmann® II Micro™ External Fixation System Regulation Number: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances Regulation Name: and accessories Regulatory Class: II Product Code: KTT Dated: July 28, 2005 Received: July 28, 2005

Dear Ms. Kelly:

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 - Ms. Vivian Kelly

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter watification. The FDA finding of substantial equivalence of your device to a legally premated noticated 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 (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 vours,

A. Hytl. Rlurdu
Mark N. Melkerson

Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

13-12-14-14-1

510(k) Number (if known):

Device Name: Hoffmann® II Micro™ External Fixation System

. . . . .

Indications for Use:

Bone fracture fixation .
. Osteotomy
Arthrodesis .
Correction of deformity .
Revision procedure where other treatments or devices have been unsuccessful .
Non-unions and delayed unions .
Compression/distraction and lengthening .

Over-The-Counter Use Prescription Use >< AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General. Restorative,
and Neurological Devices
Page 1 of 1

510(k) Number	K052037
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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.