SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]

K994143 · Smith & Nephew, Inc. · JDW · Feb 18, 2000 · Orthopedic

Device Facts

• Record ID: K994143
• Device Name: SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
• Applicant: Smith & Nephew, Inc.
• Product Code: JDW · Orthopedic
• Decision Date: Feb 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Post-traumatic joint contracture which has resulted in loss of range of motion. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction. Open and closed fracture fixation. Pseudoarthrosis of long bones. Limb lengthening by epiphyseal or metaphyseal distraction. Correction of bony or soft tissue deformities. Correction of segmental bony or soft tissue defects. Joint arthrodesis. Infected fractures or nonunions. Management of comminuted intra-articular fractures of the distal radius.

Device Story

Smith & Nephew External Fixation System comprises various unilateral and multilateral fixation devices; used for orthopedic stabilization, distraction, and deformity correction. Components include frames, hinges, and fasteners; applied externally to bone segments to provide structural support or distraction. Operated by orthopedic surgeons in clinical or surgical settings. Device stabilizes fractures, facilitates bone healing, or corrects alignment through mechanical distraction or rigid fixation. Benefits include restoration of limb function, bone union, and deformity correction. No electronic or software components.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices with a long history of clinical use.

Technological Characteristics

Materials: aluminum, stainless steel, composite, bronze, rubber, and radiolucent non-reinforced thermoplastic. System types: unilateral and multilateral external fixators, including joint hinges. Mechanical fixation principle. No energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring fracture fixation (open/closed, comminuted intra-articular distal radius, infected), treatment of pseudoarthrosis, limb lengthening, joint arthrodesis, correction of bony/soft tissue deformities/defects, and management of post-traumatic joint contractures.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Hex-Fix® Field Fixator – Smith & Nephew
• Richards Colles Fracture Frame - Smith & Nephew
• Simple Small External Fixator - Synthes
• Compass® Universal Hinge - Smith & Nephew
• Richards External Fixation System - Smith & Nephew
• Taylor Spatial Frame External Fixation System - Smith & Nephew

Submission Summary (Full Text)

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K994143

#### 510(K) Summary of Safety and Effectiveness FEB 1 8 2000 Smith & Nephew External Fixation System

### Substantial Equivalence Information

In the table below, components in the Smith & Nephew External Fixation System listed in the left column are substantially equivalent to the legally marketed predicate devices shown in the column on the right. 510(k) numbers for the legally marketed, predicate devices are provided in Table 18 (see Exhibit 17).

| Smith & Nephew External Fixation System | Legally Marketed Predicate Device |
|------------------------------------------------------------------------|-------------------------------------------------------------------|
| Unilateral External Fixation System | Hex-Fix® Field Fixator – Smith & Nephew |
| Unilateral Wrist External Fixator<br>with Double Ball Joints (DBJ) | Richards Colles Fracture Frame - Smith &<br>Nephew |
| Unilateral Wrist External Fixator<br>for Distal Radius Fractures (DFR) | Simple Small External Fixator - Synthes |
| Proximal Interphalangeal (PIP) Joint Hinge | Compass® Universal Hinge - Smith &<br>Nephew |
| Multilateral External Fixation System | Richards External Fixation System - Smith &<br>Nephew |
| Taylor Spatial Frame External Fixation System | Taylor Spatial Frame External Fixation<br>System - Smith & Nephew |
| Ankle Hinge Fixator | Compass® Universal Hinge - Smith &<br>Nephew |

All of the devices listed above have similar indications for use, similar material composition and utilize similar designs. The safety and effectiveness of external fixators is based on the long history of use of these devices in the orthopedic market place.

### Indications for Use

- Post-traumatic joint contracture which has resulted in loss of range of motion. ●
- Fractures and disease which generally may result in joint contractures or loss of range of motion and . fractures requiring distraction.
- Open and closed fracture fixation. ●
- Pseudoarthrosis of long bones. .
- Limb lengthening by epiphyseal or metaphyseal distraction. .
- Correction of bony or soft tissue deformities. ●
- . Correction of segmental bony or soft tissue defects.
- Joint arthrodesis.
- Infected fractures or nonunions. ●
- Management of comminuted intra-articular fractures of the distal radius. .

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### Device Description

..............................................................................................................................................................................

- The Smith & Nephew Unilateral External Fixator is a unilateral external fixation device used for the indications listed previously. Major components are made of aluminum, stainless steel and composite materials with some fastener components made from bronze or rubber. These materials are similar to those used in other legally marketed unilateral fixators.
The Smith & Nephew Unilateral Wrist Fixators are unilateral external fixation devices used for the indications listed previously. All components are made from stainless steel, aluminum or composite materials. These materials are similar to those used in other legally marketed unilateral wrist fixators.

The Smith & Nephew Proximal Interphalangeal (PIP) Joint Hinge is a unilateral fixation device used for the indications listed previously. Major components are made from a radiolucent, non-reinforced thermoplastic. Various other components and fasteners are made from stainless steel. These materials are similar to those used in other legally marketed unilateral fixators.

The Smith & Nephew Multilateral External Fixation System is a multilateral fixation device used for the indications listed previously. Major components are made from stainless steel, aluminum or composite materials. These materials are similar to those used in other legally marketed multilateral fixators.

The Taylor Spatial Frame External Fixation System is a multilateral fixation device used for the indications listed previously. Major components are made from stainless steel, aluminum or composite materials. These materials are similar to those used in other legally marketed multilateral fixators.

The Smith & Nephew Ankle Hinge Fixator is used with either al or multilateral fixation device for the indications listed previously. Major components are made from composite and stainless steel materials. These materials are similar to those used in other legally marketed unilateral or multilateral fixators.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 8 2000

Mr. David Henley Clinical/Regulatory Specialist SMITH & NEPHEW, INC. 1450 Brooks Road Memphis. Tennessee 38116

Re: K994143

Trade Name: External Fixation System Regulatory Class: II Product Code: JDW Dated: December 7, 1999 Received: December 8, 1999

Dear Mr. Henley:

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 control provisions of the Act. The general control 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 requirement, 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.

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.

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Page 2 - Mr. David Henley

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" (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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Nel R.R. Ogden for
James E. Dillard III

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

Enclosure

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### Indications Statement

Indications for use for the Smith & Nephew External Fixation System are as follows:

- Post-traumatic joint contracture which has resulted in loss of range of motion. ●
- Fractures and disease which generally may result in joint contractures or loss of range of motion and . fractures requiring distraction.
- Open and closed fracture fixation. ●
- Pseudoarthrosis of long bones. .
- Limb lengthening by epiphyseal or metaphyseal distraction. ●
- Correction of bony or soft tissue deformities. .
- Correction of segmental bony or soft tissue defects. .
- Joint arthrodesis. .
- Infected fractures or nonunions. ●
- Management of comminuted intra-articular fractures of the distal radius. .

Nho for JZD
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(Division Sign-Off)
Division of General Restorative Devices
K. GAUUL 2

510(k) Number K994143

Yes Prescription Use (Per 21 CFR 801.109)