CERCLAGE CABLE WITH HEX BUTTON

K974016 · Pioneer Surgical Technology · JDQ · Dec 19, 1997 · Orthopedic

Device Facts

• Record ID: K974016
• Device Name: CERCLAGE CABLE WITH HEX BUTTON
• Applicant: Pioneer Surgical Technology
• Product Code: JDQ · Orthopedic
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cerclage Cable with Hex Button device is indicated for use where wire or cable is used in conjunction with bone screws and/or plating. The system is designed to provide increased compression as compared to only a screw and/or plate in situations where there is inadequate bone stock, multiple fractures or butterfly fragments. The Cerclage Cable with Hex Button device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the plate.

Device Story

Cerclage Cable with Hex Button is a bone fixation system for long bone fractures. It consists of a cable and a button that seats into the hex of a bone screw. The cable passes through the button and around the bone; a tensioner and crimp are used to apply compression and lock the cable in place. The device is used by surgeons in an operating room setting to provide stabilization and compression in conjunction with bone plates and screws. It benefits patients by providing additional fixation strength in complex fracture scenarios where bone stock is compromised.

Clinical Evidence

Bench testing only. Static yield loading values were compared between the subject device and predicate devices, demonstrating equivalent performance.

Technological Characteristics

System includes cerclage cable, crimp, and hex button. Operates via mechanical tensioning and crimping to provide bone compression. Designed for use with commercially available bone screws and plates. No software or electronic components.

Indications for Use

Indicated for patients with long bone fractures requiring cerclage wire, cable, or band fixation in combination with bone plates and screws, particularly in cases of inadequate bone stock, multiple fractures, or butterfly fragments.

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

• Pioneer Laboratories Bone Plate with Cerclage Cable (K974016)
• Bone Plate with Cerclage Cable Device (K974016)
• Dall-Miles Broad Bone Plate

Submission Summary (Full Text)

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

510(K) Summary 5.

# Pioneer Laboratories 510(K) Notification Summary For Cerclage Cable with Hex Button

#### Administrative Information

Manufacturer Identification and Sponsor:

Pioneer Laboratories 375 River Park Circle Marquette, MI 49855-1781 Telephone: [phone] FAX: [phone]

Official Contact:

Burns Severson Vice President, Regulatory Affairs/Quality Assurance

Date Prepared:

### Device Identification

Proprietary Name: Cerclage Cable with Hex Button

Common Name Plate, Fixation, Bone

Classification Name and Reference: Cerclage, Bone fixation Regulation Number: CFR 888.3010 Classification Number: 87JDQII

> Plate, Fixation, Bone Regulation Number: CFR 888.3030 Classification Number: 87JDQII

Devices on which substantial equivalence is claimed:

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

### Device Description

The Cerclage with Hex Button is a cerclage cable and a button device that links the cable and bone screw together . The button is positioned in the hex of a bone screw. The cerclage cable is passed through the button and around the bone. The cerclage is crimped to lock the cable in place.

#### Intended Use

The Cerclage Cable with Hex Button device is indicated for use where wire or cable is used in conjunction with bone screws and/or plating. The system is designed to provide increased compression as compared to only a screw and/or plate in situations where there is inadequate bone stock, multiple fractures or butterfly fragments. The Cerclage Cable with Hex Button device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the plate.

### Technological Characteristic Compared to Predicate Device

All the devices use cables, crimps, and a bone plate as a system used for long bone fracture fixation. Each system uses a tensioner and crimp to apply compression, and lock the cable. Each system has a stabilizing feature that limits longitudinal movement of the cable. The Dall-Miles Broad Bone Plate device places the rectangular crimp and cable over the bone plate. The Pioneer Laboratories Bone Plate with Cerclage Cable device has the crimp internal to the plate. The Bone Plate with Cable device has the oval crimp adjacent to the plate with the cable passing through a hole in the plate.

The Cerclage with Hex Button has a cerclage adiacent to the plate with the cable passing through a hole in the hex button that is positioned in the hex of the plate screw.

#### Performance Data

The Cerclage Cable with Hex Button device was predicated on the use of the Pioneer Laboratories Bone Plate with Cerclage Cable and Bone Plate with Cerclage Cable Device. The static vield loading values indicated that the Cerclage Cable with Hex Button device is equivalent to the values of the three predicate devices.

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### DEC 19 1997

Mr. Burns Severson "Vice President, Regulatory Affairs/Quality Assurance Pioneer Laboratories 375 River Park Circle Marquette, Michigan 49855

K974016 Re: Cerclage Cable with Hex Button Requlatory Class: II Product Code: JDQ Dated: October 16, 1997 Received: October 22, 1997

Dear Mr. Severson:

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, Druq, 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 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 Requlation (QS) for Medical Devices: General requlation (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 requlation 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 miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

#### Paqe 2 - Mr. Burns Severson

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" (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 Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Pioneer Laboratories

# Cerclage Cable with Hex Button Device

# Indications for Use

The Cerclage Cable with Hex Button device is indicated for use where wire, cable, or band cerclage is used in combination with plates. The Cerclage Cable with Hex Button device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the plate.

se
(Fe) 21 CFR 801.109)
X

colly

(Division Sign-Off) Division of General Restorative Devices y 2974016 510(k) Number _