LORENZ STERNAL CLOSURE SYSTEM

K033740 · Walter Lorenz Surgical, Inc. · HWC · Dec 15, 2003 · Orthopedic

Device Facts

• Record ID: K033740
• Device Name: LORENZ STERNAL CLOSURE SYSTEM
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

Device Story

The Lorenz Sternal Closure System consists of 2.4 mm diameter self-drilling screws used for bone fixation. The system is designed for use in sternal reconstructive surgical procedures and stabilization of anterior chest wall fractures. The self-drilling feature allows for implantation without a pre-drilled hole, though pre-drilling remains an option. The device is provided non-sterile and is intended for single use; it requires steam sterilization by the user prior to surgery. Surgeons utilize the system to provide mechanical stability to the sternum following sternotomy or trauma. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation appliance; 2.4 mm diameter self-drilling screws; non-sterile; single-use; steam sterilization required.

Indications for Use

Indicated for patients requiring stabilization and fixation of anterior chest wall fractures, including sternal fixation post-sternotomy and sternal reconstructive surgical procedures.

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

• Lorenz 2.4 Self Drilling Screw (K03228)
• Lorenz Sternal Closure System (K011076)

Submission Summary (Full Text)

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

# DEC 1 5 2003

K033740
page 1 of 1

### Summary of Safety and Effectiveness

| Device Name: | Lorenz Sternal Closure System |
|----------------------|-----------------------------------------------------------------------------|
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories |
| Device Product Code: | 87HRS (21 CFR 888.3030) |

#### Intended Use:

Lorenz Sternal Closure System is intended for use in the stabilization of fractures of the auterior chest Lorell. Sternal Crosure Dystem is meaners and Sternal reconstructive surgical procedures.

#### Description:

The Lorenz Sternal Closure System 2.4 self drilling screws are 2.4 mm in diameter and the lengths may range up to I the Lorental Storal Clobal v Systems so that a preditled hole is not required, but may be used.

#### Sterility Information:

The Lorenz Sternal Closure System will be marketed as non-sterile, single use devices. Steam Sterilization recommendations are included in the package insert and can be seen in Attachment I.

#### Substantial Equivalence:

Walter Lorenz considers the Lorenz Sternal Closure System equivalent Lorenz 2.4 Self Drilling Screw (K03228) and Lorenz Sternal Closure System (K011076) TAB 3 includes a substantial equivalence comparison table. TAB 4 and Lorenz Stemar Crosure Dynam (10717) 12 1 Self Drilling Screw (K03228) and Lorenz Stemal Closure System (K011076)

#### Possible risks:

- .1. Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device.
- Nonunion or delayed union, which may lead to breakage of the implant. 2.
- Migration, bending, fracture or loosening of the implant. 3.
- Metal sensitivity, or allergic reaction to a foreign body. র্য :
- Decrease in bone density due to stress shielding. ડા
- Pain, discomfort, abnormal sensation, or palpability due to the presence of the device. 6.
- Increased fibrous tissue response around the fracture site and/or the implant. 7.
- Necrosis of bone. 8.
- ਹੈ. Inadequate healing.
- Selection of screws which are longer than the depth of the sternum may cause possible impingement on 10. structures internal to the chest wall including vessels, pleura and other structures.

Apart from these adverse effects there are always possible complical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.

16

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

DEC 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kim Reed Senior Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K033740 Trade/Device Name: Lorenz Sternal Closure System Regulation Numbers: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HWC Dated: November 26, 2003 Received: November 28, 2003

Dear Ms. Reed:

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Kim Reed

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 N. Milken

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}------------------------------------------------

## STATEMENT OF INDICATIONS FOR USE

510(k) Number: _ K 033740 ______________________________________________________________________________________________________________________________________________________________________________

Device Name: Lorenz Sternal Closure System Indications For Use:

Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

### (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)

for Math N Melken

storative
ces

K033740

2