HOFFMAN II HYBRID RING CLAMP

K011948 · Howmedica Osteonics Corp. · LXT · Jul 13, 2001 · Orthopedic

Device Facts

• Record ID: K011948
• Device Name: HOFFMAN II HYBRID RING CLAMP
• Applicant: Howmedica Osteonics Corp.
• Product Code: LXT · Orthopedic
• Decision Date: Jul 13, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This subject component, when used together with the components of the Hoffmann® II and/or Monotube® TRIAX™ External Fixation Systems and Apex® Pins, creates an external fixation frame construct. The subject device is intended to be used in the construction of external fixation frames to provide 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 Hybrid Ring Clamp is a metallic component for external fixation frames; used with Hoffmann® II, Monotube® TRIAX™ systems, and Apex® pins. Device provides mechanical stabilization for open/unstable fractures, osteotomies, arthrodesis, and deformity corrections. Operated by surgeons in clinical/OR settings. Device functions as a structural clamp to secure pins/wires to fixation frames; enables rigid bone stabilization. Benefits include fracture management when internal fixation or casting is contraindicated due to soft tissue injury. Modified from predicate to address manufacturing issues.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metallic bone fixation appliance; component of external fixation frame system. Design and materials are consistent with the predicate device for use in orthopedic stabilization.

Indications for Use

Indicated for bone fracture fixation, osteotomy, arthrodesis, deformity correction, revision procedures, and bone reconstruction in patients requiring external stabilization of open or unstable fractures where internal fixation or casting is precluded.

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

• Hoffmann® II Hybrid Ring Clamp (K000197)

Submission Summary (Full Text)

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# JUL 1 3 2001

K011948

Special 510(k) Premarket Notification

## Summary of Safety and Effectiveness Hoffmann® II Hybrid Ring Clamp

#### Submission Information

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

Contact Person:

Date of Summary Preparation:

#### Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677 Karen Ariemma Regulatory Affairs Specialist June 20, 2001

Hoffmann® II Hybrid Ring Clamp External Fixation Frame Component Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030

### Predicate Device Identification

The Hoffmann® II Hybrid Ring Clamp was determined substantially equivalent via 510(k) K000197.

#### Device Description

The Hoffmann® II Hybrid Clamp is being modified to address issues in manufacturing.

#### Intended Use:

This subject component, when used together with the components of the Hoffmann® II and/or Monotube® TRIAX™ External Fixation Systems and Apex® Pins, creates an external fixation frame construct. The subject device is intended to be used in the construction of external fixation frames to provide 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.

#### Statement of Technological Comparison:

Analysis demonstrates comparable properties of the subject to the predicate device.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 3 2001

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

Re: K011948

Trade/Device Name: Hoffmann® II Hybrid Ring Clamp Regulation Number: 888.3030 Regulatory Class: II Product Code: LXT Dated: June 20, 2001 Received: June 21, 2001

#### Dear Ariemma:

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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 - Ms. Karen Ariemma

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 regulation (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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Mark N. Melkerson

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): Koj 1948

#### Device Name: Hoffmann® II Hybrid Frame System

Indications For Use:

The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex™ Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX™ External Fixation System.

This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation. The indications for use of metallic external fixation devices include:

- Bone fracture fixation .
- Osteotomy .
- . Arthrodesis
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful ●
- Bone reconstruction procedures .

(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) | | |

for Mark Milliken (Optional Format 1-2-96)

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| 510(k) Number | K011948 |
|---------------|---------|
|---------------|---------|