LORENZ PECTUS SUPPORT BAR

K972420 · Walter Lorenz Surgical, Inc. · HRS · Aug 11, 1997 · Orthopedic

Device Facts

• Record ID: K972420
• Device Name: LORENZ PECTUS SUPPORT BAR
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use in surgical procedures to repair Pectus Excavation and other sternal deformities.

Device Story

Lorenz Pectus Support Bar is a stainless steel implant used in surgical procedures to correct Pectus Excavatum and sternal deformities. The device consists of a bar, variable in length (7 to 14 inches) and 0.50 inches wide, featuring two holes and notches at both ends to facilitate suturing to the lateral chest wall. The surgeon manually shapes the bar prior to insertion to match the patient's anatomy. The device is intended for long-term implantation. It is used by surgeons in an operating room setting. Potential risks include inadequate bone quality, implant malpositioning, infection, nerve injury, and bending or fracture of the implant.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel bar; variable length 7-14 inches; 0.50 inches wide; includes holes and notches for suture fixation; manual shaping by surgeon; long-term metallic implant.

Indications for Use

Indicated for patients undergoing surgical repair of Pectus Excavatum and other sternal deformities.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• The Adkins Strut (American V. Mueller)
• The Strib (Medic-Made Company)

Submission Summary (Full Text)

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K972420 AU

## Summary of Safety and Effectiveness

Device Name: Lorenz Pectus Support Bar

Classification Name and Reference: Plate, Fixation, Bone 87 HRS (CFR 888.3030)

Device Description: A stainless steel bar, variable length from 7 to 14 inches, and 0.50 inches wide, with two holes and notches on both ends for sutures to secure the bar to the lateral chest wall (a drawing is included in Attachment I.) . The bar is shaped by the surgeon prior to insertion.

## Potential Risks:

The potential risks associated with the support bar are the same as with any long-term, metallic implant These include but are not limited to the following;

- Inadequate bone quality
- Malpositioning of implant .
- Infection .
- o Nerve Injury
- Bending/fracture of implant .

## Substantially Equivalent Devices:

- The Adkins Strut, manufactured by American V. Mueller ●
- The Strib, manufactured by the Medic-Made Company .

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all caps and evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diana Preston Requlatory Affairs Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville. Florida 32218-2480

AUG 1 1 1997

Re : K972420 Lorenz Pectus Support Bar Requlatory Class: II Product Code: HRS Dated: June 23, 1997 Received: June 27, 1997

Dear Ms. Preston:

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 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 Requlations, 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 In addition, FDA may publish further announcements action. 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 requlations.

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## Page 2 - Ms. Diana Preston

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 ene regalacion chororous ( 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

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Page _1_ of _l_

510(k) Number (if known): K972420

Device Name: Lorenz Pectus Support Bar

Indications For Use: This device is intended for use in surgical procedures to repair Pectus Excavation and other sternal deformities.

(PLEASE DO NOT WRITE BELOG THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED!

Concurrence of CDRH, Office of Device Evaluation (ODE)

Acsella

(Division Sign-Off) Division of General Restorative Lie nees 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use_X (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)