HOFFMANN II FOOT RING

K041706 · Howmedica Osteonics Corp. · KTT · Sep 8, 2004 · Orthopedic

Device Facts

• Record ID: K041706
• Device Name: HOFFMANN II FOOT RING
• Applicant: Howmedica Osteonics Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hoffmann ® II Hybrid Frame System is intended to provide stabilization of open and/or unstable fractures 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.

Device Story

The Hoffmann II Foot Ring is an external fixation frame component designed for orthopedic stabilization. It functions as part of the Hoffmann II Hybrid Frame System, integrating with fixation pins and Kirschner wires to stabilize fractures or support reconstruction procedures in the foot. The device is used in clinical settings by surgeons to provide rigid support for unstable fractures or complex foot deformities where internal fixation is contraindicated due to soft tissue status. It provides mechanical stabilization, allowing for bone healing or corrective alignment. The device is a passive mechanical component; it does not process data or provide clinical outputs.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metallic external fixation frame component. Designed for use with commercially available fixation pins and Kirschner wires. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring bone fracture fixation, osteotomy, arthrodesis, deformity correction, revision procedures, bone reconstruction, foot fusions/replantations, Charcot foot reconstruction, and Lisfranc dislocations. Used when soft tissue injury precludes IM rodding or casting.

Regulatory Classification

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.

Reference Devices

• Hoffmann External Fixation System
• Hoffmann II External Fixation System
• Hoffmann II Compact External Fixation System
• Hoffmann II Hybrid Frame System
• Monotube Triax External Fixation System

Submission Summary (Full Text)

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Hoffmann* II Foot Ring

SEP = 8 2004

510(k) Summary of Safety and Effectiveness for the Hoffmann® II Foot Ring

K041706
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| Proprietary Name: | Hoffmann® II Foot Ring |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Frame Component |
| Classification Name and Reference | Single/multiple component metallic bone fixation<br>appliances and accessories, 21 CFR §888.3030 |
| Device Product Code: | 87 KTT |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | June 21, 2004 |

#### Intended Use:

The Hoffmann ® II Hybrid Frame System is intended to provide stabilization of open and/or unstable fractures 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.

## Description:

The new Foot Ring components are additions to the Hoffmann ® II Hybrid Frame System. They are external fixation frame components intended to be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax " External Fixation System and in conjunction with commercially available Fixation Pins such as the Apex® Pins and/or Kirschner Wires.

## Substantial Equivalence:

Equivalency is based on similarities in intended use, materials and design to the predicate devices. Testing has been conducted on the Hoffmann® II Foot Ring components demonstrating substantial equivalence to the predicate devices.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 8 2004

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

Re: K041706 Trade/Device Name: Hoffmann® II Foot Ring Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: June 21, 2004 Received: June 23, 2004

Dear Ms Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assumer in 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 r ou mayy atests 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 11 your de rice to such additional controls. Existing major regulations affecting your device can may be subject to back additions, 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 as made a determination that your device complies with other requirements of the Act that I Dr Had Intatutes and regulations administered by other Federal agencies. You must or any I odolar statutes and equirements, 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) This letter with anow you to ogen manieming of substantial equivalence of your device to a legally premarket notheadon: "The PDF mailing sification 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 If you desire spocente arrivier J at [phone]. Also, please note the regulation entitled, Colliact the Office of Comphalled at (58 r otification" (21CFR Part 807.97). You may obtain Misolanding by release to premaintention on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark H. Mellema

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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# Indications for Use

510(k) Number (if known): k041706

Device Name: Hoffmann® II Foot Ring

Indications for Use:

The Hoffmann ® II Hybrid Frame System is intended for use to provide stabilization of open and/or unstable fractures 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 .
- Bone reconstruction procedures .
- Fusions and replantations of the foot .
- Charcot foot reconstruction and Lisfranc dislocations .

Prescription Use
(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 OF
NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

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510(k) Number K041706