HOFFMANN II MIAMI POST

K983419 · Howmedica Corp. · HRS · Nov 25, 1998 · Orthopedic

Device Facts

• Record ID: K983419
• Device Name: HOFFMANN II MIAMI POST
• Applicant: Howmedica Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This submission describes an external fixation frame component used to connect fixator rings with 6mm mounting holes to the Hoffmann® II rod to rod and pin to rod clamps. This device is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

Device Story

Hoffmann® II Miami Post is a mechanical component for external fixation systems; connects circular fixation rings (with 6mm mounting holes) to Hoffmann® II rod-to-rod and pin-to-rod clamps. Used by orthopedic surgeons in clinical settings to create hybrid fixation constructs. Device provides structural stabilization for long bone fractures, arthrodeses, or distraction osteogenesis. No electronic or software components; purely mechanical hardware.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel; machined from bar stock; mechanical fixation component; dimensions designed for 6mm mounting holes; connects circular rings to Hoffmann® II rod/pin clamps.

Indications for Use

Indicated for patients requiring treatment of fractures, arthrodeses, or distraction osteogenesis of long bones (tibia, femur, humerus), including stabilization of open or unstable fractures where 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.

Predicate Devices

• Howmedica Monticelli/Spinelli Sliding Clamp
• Synthes Ring-to-Rod Clamp
• Zimmer Torus Ring-to-Rod Clamp

Submission Summary (Full Text)

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K9834119

**510(k) Summary**

Proprietary Name: Common Name: Classification Name & Reference: Requiatory Class: Device Product Code:

Hoffmann® II Miami Post External Fixation Frame Component External Fixation Device (888.3040) 21 CFR = OR(87)JEC

For information contact:

Joseph Volpe Senior Regulatory Affairs Specialist Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070 Telephone: [phone] Fax: [phone]

Date prepared: September 28, 1998

# Intended use:

This submission describes an external fixation frame component used to connect fixator rings with 6mm mounting holes to the Hoffmann® II rod to rod and pin to rod clamps. This device is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

# Description:

The Hoffmann® II Miami Post is designed to connect rings with 6mm holes to Hoffmann®II rod to rod and pin to rod clamps. This Post attaches the circular fixation rings to the external fixations rods. The Post is manufactured from Stainless Steel and is machined from bar stock.

# Substantial Equivalence:

Equivalency of this device is based on similarities in intended use, materials, design and operational principles to the Howmedica Monticelli/Spinelli Sliding Clamp (with articulating coupling), the Synthes Ring-to-Rod Clamp and the Zimmer Torus Ring-to-Rod Clamp.

Testing of this device demonstrates substantial equivalence to another predicate ring system.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV ? 5 1998

Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey

Re: K983419 Hoffmann® II Miami Post Trade Name: Requlatory Class: II Product Code: HRS Dated: September 28, 1998 Received: September 29, 1998

Dear Mr. Dichiara:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Mr. John F. Dichiara

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): Not Known

Hoffmann® II Miami Post Device Name:

Indications for Use:

The Hoffmann® II Miami Post is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. It is to be used to provide a hybrid construct combing any 6mm external fixation ring to the Hoffmann® II rod to rod and pin to rod clamps. The post will extend the use of the Hoffmann® II External Fixation System to Hybrid frames that utilize circular rings with 6mm mounting holes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) of General Restorative Devices

510(k) Number