SYNTHES SACRAL BAR SYSTEM

K001720 · Synthes (Usa) · JDW · Aug 24, 2000 · Orthopedic

Device Facts

• Record ID: K001720
• Device Name: SYNTHES SACRAL BAR SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JDW · Orthopedic
• Decision Date: Aug 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

Device Story

The Synthes Sacral Bar System is a metallic bone fixation device used for stabilizing posterior pelvic fractures and sacro-iliac joint dislocations. The system comprises a fully threaded bar with a trocar point for guidance through pre-drilled bone holes, oval washers, and a dual-nut mechanism (rounded and straight). The rounded nuts mate with washers to provide compression, while the straight nuts act as locking components to maintain that compression. The device is intended for surgical use by physicians to provide rigid fixation, facilitating bone healing and structural stability in the pelvic region.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implant quality stainless steel; threaded bar with trocar point; oval washers; dual-nut compression/locking mechanism; lengths 120-260 mm in 10 mm increments; mechanical fixation device.

Indications for Use

Indicated for fixation of posterior pelvic fractures, specifically in the posterior superior and posterior inferior iliac spine regions, and for sacral fractures and sacro-iliac joint fracture-dislocations.

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

• Zimmer Threaded Sacral Rod
• Synthes Threaded Bolt

Submission Summary (Full Text)

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## AUG 2 4 2000

#### Summary of Safety and Effectiveness Information 3.0

SPONSOR:

Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone] Contact: Angela Silvestri

Synthes Sacral Bar System

DEVICE NAME:

CLASSIFICATION:

21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.

Zimmer Threaded Sacral Rod PREDICATE DEVICES: Synthes Threaded Bolt

DEVICE DESCRIPTION: The Synthes Sacral Bar System consists of a threaded bar, washers, and nuts. The bars are fully threaded. One end of the bar has a trocar point to guide the bar through pre-drilled holes. The bars are available in lengths ranging from 120 to 260 mm, in 10 mm increments. The washers that are used with this system are oval shaped and are designed to slide freely along the bars. Both rounded and straight nuts are provided with this system; the rounded nuts mate with the washers to create compression, while the straight nuts are then added to wedge against the rounded nuts to maintain compression.

INTENDED USE:

MATERIAL:

The Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.

Implant quality stainless steel.

Synthes Sacra! Bar System 510(k) Synthes (USA)

### CONFIDENTIAL

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 4 2000

Ms. Angela Silvestri Manager, Regulatory Affairs Synthes U.S.A. 1690 Russell Road Paoli. Pennsylvania 19301

Re: K001720 Trade Name: Sacral Bar System Regulatory Class: II Product Code: JDW Dated: June 5, 2000 Received: June 6, 2000

## Dear Ms. Silvestri:

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 - Ms. Angela Silvestri

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 yours,

Russell Page

Sw 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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#### Indications for Use Statement 2.0

Page _ 1 __ of _______________________________________________________________________________________________________________________________________________________________ 1

| 510(k) Number (if known): | K001720 |
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Synthes Sacral Bar System Device Name: _________________________________________________________________________________________________________________________________________________________________

INDICATIONS/CONTRAINDICATIONS:

The Synthes Sacral Bar System is intended for fixation of fractures of the I ne Uyithes Dacrar Data of the posterior superior iliac spine and posterior posterior pervis, in areas and fractures and fracture-dislocations of the sacro-iliac joint.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Purnell Jury
(Division Sign-Off)

(Division Sign-On)
Division of General Restorative Devices
510(k) Number K001720

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Synthes Sacral Bar System 510(k) Synthes (USA)

CONFIDENTIAL