KLS-MARTIN STERNAL PLATING SYSTEM

K032413 · KLS-Martin L.P. · HRS · Oct 10, 2003 · Orthopedic

Device Facts

• Record ID: K032413
• Device Name: KLS-MARTIN STERNAL PLATING SYSTEM
• Applicant: KLS-Martin L.P.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended use for the KLS-Martin Sternal Plating System is in stabilization and fixation of anterior chest wall fractures, Including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures.

Device Story

Sternal Plating System provides rigid bone fixation for sternal fragments. Device consists of titanium alloy (Ti-6Al-4V) plates (1.0mm–3.0mm thickness) and bone screws (2.3mm–3.2mm diameter). Plates feature elongated midsection to facilitate re-entry during subsequent thoracic procedures. Used by surgeons in clinical/OR settings to stabilize sternum post-sternotomy or for reconstruction. System provides greater stiffness and lower lateral displacement compared to traditional stainless steel cerclage wire fixation, potentially improving sternal stability and healing outcomes.

Clinical Evidence

Evidence includes biomechanical study (Ozaki et al.) comparing prototype titanium 'H' plates to stainless steel cerclage wires in human cadavers. Results showed greater stiffness and lower lateral displacement for rigid titanium plates. Additional support provided by clinical literature (Sargent et al., Cheng et al., Buchman et al.) demonstrating superiority of plating systems over traditional sternal wiring.

Technological Characteristics

Titanium Alloy (Ti-6Al-4V) plates and screws. Plate thickness 1.0mm–3.0mm; screw diameter 2.3mm–3.2mm. Rigid fixation via bone screws. Non-modular design. Mechanical device; no software or energy source.

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

• Lorenz Sternal Closure System (K011079)
• ETHICON Surgical Stainless Steel Suture U.S.P. sizes 5 - 7

Submission Summary (Full Text)

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K032413

## 510(K) SUMMARY

| Submitter: | KLS-Martin, L.P.<br>11239-1 St. Johns Industrial Parkway South<br>Jacksonville, FL 32246<br>Phone: [phone]<br>Fax: [phone] |
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| Contact Person: | Jennifer Damato<br>Director RA/QA |
| Date of Summary: | 20 June, 2003 |
| Device Name: | KLS-Martin Sternal Plating System |
| Trade Name: | Sternal Plating System |
| Common Name: | Plate, Fixation, Bone |
| Classification<br>Name and Number: | Plate, Fixation, Bone (CFR 888,3030) |
| Regulatory Class: | Class II |
| Predicate Devices: | Lorenz Sternal Closure System (K011079) and<br>ETHICON Surgical Stainless Steel Suture U.S.P. sizes 5 - 7 |
| Device<br>Description: | KLS - Martin Sternal Plating System consists of plates<br>having a thickness of 1.0mm to 3.0mm and screws having a<br>diameter of 2.3mm to 3.2mm. |
| Intended Use: | Intended use for the KLS-Martin Sternal Plating System is<br>in stabilization and fixation of anterior chest wall fractures,<br>Including Sternal Fixation subsequent to Sternotomy and<br>Sternal reconstructive procedures. |

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Technological Characteristics:

## Similarities to Predicate

Intended Use for the KLS-Martin Stemal Plating System is the same as the Lorenz Stemal Closure System with Modular Screws (K011079) and the Ethicon Surgical Stainless Steel Suture. The function of these systems is to affix bonv sternum fragments.

The KLS-Martin Sternal Plating System uses previously cleared Titanlum Allov (TI-6 Al-4V) screws to affix the plates to the stemum. The plate design includes an elongated midsection to facilitate quick re-entry in subsequent thoracic procedures. The plates and screws are substantially equivalent in strength to the Lorenz Sternal Closure System with Modular Screws (K011079).

## Differences to Predicate

The KLS-Martin Sternal Plating System is the same as the Lorenz Stemal Closure System with Modular Screws (K011079) with the exception that the screw is a standard bone screw and not a modular screw.

The KLS-Martin Sternal System is substantially equivalent Substantial Equivalence: in application and function to the Lorenz Sternal Closure System with Modular Screw and Ethicon Surgical Stainless Steel Suture, U.S.P. sizes 5 to 7.

> Substantial equivalence is based on comparison of performance, method of rigid bone fixation and clinical literature assessment.

> Intended use of the KLS-Martin Stemal System is the same as the Lorenz Stemal Closure System with Modular Screw; the function of this system being to affix Stemal bony fragments.

> Superiority of Sternal Plating to sternum wiring has been demonstrated in clinical studies. Support of this statement includes studies by Sargent et al., Cheng et al., Buchman et al., and Ozaki et al.

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Clinical/Non-clinical Tests:

The three clinical studies used to support the Statement of Superiority of Plating Systems are by Sargent et al., Cheng et al. and Buchman et al. These studies are Included in the Annex.

A fourth study "Biomechanical Study of Stemal Closure Using Rigid Fixation Techniques in Human Cadavers. Ozaki et al.", directly compared the KLS-Martin Sternal Plating System prototype to cerclage wire and titanium straight plates:

> Phase I - biomechanically the fixation strength of No. 5 stainless steel cerclage wires (Ethicon, Inc., Somerville, NJ) to four-hole, titanium straight plates,

Phase II - biomechanically the fixation strength of No. 5 stainless steel cerclage wires to customized four-hole titanium "H" plates manufactured by KLS-Martin, as per design of Dr. Buchman.

This study Is included in the Annex.

Test Conclusions:

Specifically against "Biomechanical Study of Stemal Closure Using Rigid Fixation Techniques in Human Cadavers, Ozaki et al.", Phase II - biomechanically the fixation strength of No. 5 stainless steel cerclage wires to customized four-hole titanium "H" plates manufactured by KLS-Martin, as per design of Dr. Buchman.

> "In our study we found a greater stiffness and a lower lateral displacement in stema fixed with rigid custom titanium "H" plates when compared with stema fixed with stainless steel cerclage wires."

"... this study has led to the development of a rigid Stemal Plating System that is biomechanically superior to wire fixation."

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Ms. Jennifer Damato Director, Regulatory Affairs and Quality Assurance KLS-Martin, L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, FL 32246

Re: K032413

Trade/Device Name: KLS-Martin Sternal Plating 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: August 1, 2003 Received: August 5, 2003

Dear Ms. Damato:

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

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Page 2 - Ms. Jennifer Damato

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,

L. Mark N. Milliman

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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Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The logo consists of the letters "KLS" inside of a shield-like shape on the left, and the words "martin L.P." to the right of it. The "m" in "martin" is inside of a square. There is a black bar underneath the logo.

P.O. Box 50249 · Jacksonville, FL 32250-0249 904-641-7746 or 1-800-625-1557 · Fax [phone] www.klsmartin.com

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: KLS-Martin Sternal Plating System

Indications For Use:

KLS-Martin Sternal Plating System is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milham

(Division Sign-C Division of General, Restorative and Neurological Devic

510(k) Number

KO32413

Prescription Use Use (Per 21 CFR 801-109) OR

Over-The-Counter

Format 1-2-96)

(Optional