MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM

K053624 · Medicon EG · HRS · Jul 17, 2006 · Orthopedic

Device Facts

• Record ID: K053624
• Device Name: MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
• Applicant: Medicon EG
• Product Code: HRS · Orthopedic
• Decision Date: Jul 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medicon Stern-a-Fix Sternal Closure System is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Device Story

The Medicon Stern-a-Fix Sternal Closure System is a bone fixation device consisting of titanium plates and 2.4 mm locking/standard bone screws (with 2.7 mm emergency screws). The system is used by surgeons in an operating room setting to stabilize the sternum following sternotomy or reconstructive procedures. The plates are affixed to the sternum using the screws; the plates feature thinner horizontal sections to facilitate quick re-entry if necessary. The 2.4 mm screws are self-drilling, eliminating the need for pre-drilling. By providing rigid fixation, the system aims to improve sternal stability compared to traditional cerclage wire methods, potentially benefiting patients by enhancing healing and structural integrity of the chest wall.

Clinical Evidence

No clinical trials were performed. Evidence is based on bench testing and a comparative study, 'Lower Sternal Reinforcement Improves the Stability of Sternal Closure' by Dasika et al., which demonstrated that the Medicon Stern-a-Fix system provided significantly greater stability than cerclage wire in all regions of the sternum, particularly at the xyphoid.

Technological Characteristics

Materials: Titanium. Components: Plates and 2.4 mm locking/standard screws (7-15 mm lengths), 2.7 mm emergency screws. Principle: Rigid bone fixation via mechanical screw-plate attachment. Features: Self-drilling screws, thin horizontal plate sections for re-entry.

Indications for Use

Indicated for stabilization and fixation of anterior chest wall fractures, including sternal fixation following sternotomy and sternal reconstructive procedures.

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

• KLS-Martin Sternal Plating System (K032413)
• Lorenz Sternal Closure System with Modular Screw (K011076)
• Lorenz Sternal Closure System (K033740)

Submission Summary (Full Text)

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510(K) SUMMARY

Submitter:

Contact Person:

Date Prepared:

Trade Name:

Common Name:

Classification Name and
Number:

Regulatory Class:

Predicate Devices:

Description:

Intended Use:

Substantial Equivalence:

Medicon. E.G.
Gaensaecker 15
Tuttlingen, D-78532
Germany
Phone: [phone]
Fax: [phone]-9956

Andreas Burger

December 20, 2005

Stern-a-Fix Sternal Closure System

Plate, Fixation, Bone

Single/multiple component metallic bone fixation appliances and
accessories (21 CFR 880.3030, Product Code HRS)

Class II

•KLS-Martin Sternal Plating System, K032413
• Lorenz Sternal Closure System with Modular Screw, K011076
•Lorenz Sternal Closure System, K033740

The Medicon Stern-a-Fix Stermal Closure System consists of
titanium plates and 2.4 mm locking and standard bone screws, as
well as 2.7 mm emergency screws. All 2.4 mm screws are self-
drilling, i.e., a predrilled hole is not required, but may be used if
desired. Screws are provided in lengths from 7-15 mm.

The plates are affixed to the sternum using the screws. They
include thinner horizontal sections to facilitate quick re-entry.

The Medicon Stern-a-Fix Sternal Closure System is intended for
use in stabilization and fixation of anterior chest wall fractures
including sternal fixation subsequent to sternotomy and sternal
reconstructive procedures.

The Medicon Stern-a-Fix Sternal Closure System is the same as
the predicate devices in indicated use, method of rigid bone
fixation, operating principle and materials.

Fixation strength of the Medicon Stern-a-Fix bone plate for stemal
closure was compared to cerclage wire on the basis of the study
"Lower Sternal Reinforcement Improves the Stability of Sternal
Closure", by Dasika *et al*. Significantly greater stability was
recorded for the Medicon Stern-a-Fix sternal closure system in all
regions of the stemum, particularly at the xyphoid.

JUL 17 2006

MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 7 2006

Medicon, E.G. % Business Support International Ms. Angelika Scherp Regulatory Consultant AMSTEL 320-I Amsterdam Netherlands 1017AP

Re: K053624

Trade/Device Name: Medicon Stern-a-Fix Closure System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: June 6, 2006 Received: June 14, 2006

Dear Ms. Scherp:

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 complics 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

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Page 2 - Ms. Angelika Scherp

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. 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/industry/support/index.html.

Sincerely yours,
Harbara Buerm

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): KO5 3629

Device Name: Medicon Stern-a-Fix Sternal Closure System

## Indications for Use:

The Medicon Stern-a-Fix Sternal Closure System is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign Off

Division of General, Restorative, and Neurological Devices

**510(k) Number**_2053024