SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM

K031162 · Smith & Nephew, Inc. · JDQ · May 1, 2003 · Orthopedic

Device Facts

• Record ID: K031162
• Device Name: SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: JDQ · Orthopedic
• Decision Date: May 1, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cable Implants: General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing fixation techniques. Trochanteric Grips: Trochanteric reattachment whenever the trochanter is osteomized in any of the procedures listed below: 1. Primary total hip arthroplasty. 2. Revision total hip arthroplasty. 3. Any procedure using anterolateral or lateral approaches.

Device Story

Orthopaedic cabling system for bone fracture fixation; consists of cables, clamps/swages, and trochanteric grips. Used in clinical settings by surgeons during orthopaedic repair procedures. System functions by providing tension and compression to bone segments to facilitate healing. Accessory instruments are used to tension and lock the cable. Output is a mechanical fixation of bone fractures. Benefits include stabilization of fractures and reattachment of osteomized trochanters.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technological similarities to legally marketed predicate devices.

Technological Characteristics

System comprises cables, clamps/swages, and trochanteric grips. Mechanical fixation principle using tension and compression. Accessory instruments required for tensioning and locking. No software or electronic components.

Indications for Use

Indicated for patients requiring orthopaedic bone fracture fixation, including patella, femur, tibial, olecranon, and ankle fractures, as well as general cerclage and prophylactic banding. Also indicated for trochanteric reattachment during primary or revision total hip arthroplasty or procedures using anterolateral/lateral approaches.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Smith & Nephew's Orthopaedic Cable Systems (K842977)
• Smith & Nephew's Orthopaedic Cable Systems (K875156)
• Smith & Nephew's Orthopaedic Cable Systems (K924141)
• Biomet's BMP Cable System (K982545)
• Howmedica's Dall-Miles Cable System (K971741)
• Pioneer's Cerclage Cable with Hex Button (K974016)
• Zimmer's Cable-Ready Cable Grip System

Submission Summary (Full Text)

{0}------------------------------------------------

MAY - 1 2003

Smith & Nephew, Inc. Summary of Safety and Effectiveness: Orthopaedic Cable

## Contact Person and Address

Date of Summary: April 11, 2003

Kanu Vadodaria Senior Regulatory/Clinical Affairs Specialist Smith & Nephew, Inc., Orthpopaedics Division 1450 East Brooks Road Memphis, TN 38116 [phone]

K031162

page 1 of 1

Name of Device: Smith & Nephew Orthopaedic Cable Common name: Orthopedic Cabling system

### Device Classification name:

21 CFR 888.3010 Bone fixation cerclage - Class II

## Substantially Equivalent Legally Marketed Devices

The substantial equivalence of the Smith & Nephew Orthopaedic Cabling System is based on the equivalence in intended use, materials, design, operational principles and indications to the following predicate devices - Smith & Nephew's Orthopaedic Cable Systems (K842977, K875156, K924141), Biomet's BMP Cable System (K982545), Howmedica's Dall-Miles Cable System (K971741), Pioneer's Cerclage Cable with Hex Button (K974016), and Zimmer's Cable-Ready Cable Grip System.

### Device Description

The Smith & Nephew Orthopaedic Cabling System consists of: a cable with or without clamps or swages; trochanteric grips with or without clamp plates.

#### Indications for Use:

Cable Implants:

General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, fixation of spiral fractures in conjunction with intra-medullary nailing and screwing fixation techniques.

Trochanteric Grips:

Trochanteric reattachment whenever the trochanter is osteomized in any of the procedures listed below:

- Primary total hip arthroplasty. 1.
- 2. Revision total hip arthroplasty.
- 3. Any procedure using anterolateral or lateral approaches.

## Technological and Performance Characteristics:

All predicate devices use cables, swages (clamps) and trochanteric grips as a system for bone fracture fixation. Each system uses accessory instruments to provide proper tension and compression to lock the cable. The Smith & Nephew Orthopaedic Cabling System uses similar technology to achieve proper bone fracture fixation.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2003

Mr. Kanu Vadodaria Senior Regulatory/Clinical Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116

Re: K031162

Trade/Device Name: Smith & Nephew Orthopaedic Cabling System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: April 11, 2003 Received: April 14, 2003

Dear Mr. Vadodaria:

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.

{2}------------------------------------------------

Page 2 - Mr. Kanu Vadodaria

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Millan

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

{3}------------------------------------------------

# Indications for Use Statement Smith & Nephew Orthopaedic Cabling System

510(k) Number (if known): k031162

Device Name: Smith & Nephew Orthopaedic Cabling System

Indications for Use:

- a) General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing fixation techniques.
- b) Trochanteric reattachment whenever the trochanter is osteomized in any of the procedures listed below.
- 1. Primary total hip arthroplasty.
- 2. Revision total hip arthroplasty.
- 3. Any procedure using anterolateral or lateral approaches.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)

Mark A. Milkerson

Division Sign-City Division of General, Restorative and Neurological Devices

510(k) Number 5/1/03