KLS MARTIN STERNAL TALON

K051165 · KLS-Martin L.P. · HRS · Sep 7, 2006 · Orthopedic

Device Facts

• Record ID: K051165
• Device Name: KLS MARTIN STERNAL TALON
• Applicant: KLS-Martin L.P.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

KLS-Martin Sternal Talon is a two-piece, titanium alloy (TI-6AL-4V) clamping device for sternal stabilization. Device features various foot depths/lengths and a ratcheted locking system. Placed on opposing sides of the sternum, the interlocking pieces provide stabilized fixation across varying sternal widths. A three-position screw controls the ratchet (open, close, lock). Emergency re-entry is facilitated by turning the screw to the open position or utilizing designated cut points. Used by surgeons in clinical settings for sternal closure; provides mechanical fixation to support bone healing and chest wall stability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: TI-6AL-4V Titanium Alloy. Design: Two-piece interlocking clamping system with ratcheted locking mechanism and three-position screw. Features curved foot plates for medial pressure application. Mechanical fixation device; no energy source or software.

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

• Ethi-Pack Surgical Stainless Steel Suture (K931271)
• Pioneer Silicoat Sternal Cable (K993286)
• PectoFix DSF System (K000694)
• Synthes Sternal Fixation System (K010943)
• Synthes (USA) Sterile Sternal Fixation System (K050041)
• Sternal Band (K930015)
• Lorenz Sternal Closure System (K033740)

Reference Devices

• KLS Martin Sternal Plating System (K032413)

Submission Summary (Full Text)

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

K051165

0.1/3

# 510(K) SUMMARY

SEP - 7 2006

| Submitter: | KLS-Martin, L.P.<br>11239-1 St. Johns Industrial Parkway South<br>Jacksonville, FL 32246<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato<br>Director RA/QA |
| Date of Summary: | 4 May 2005 |
| Device Name: | KLS Martin Sternal Talon |
| Trade Name: | Sternal Talon |
| Common Name: | Sternal Closure System |
| Classification<br>Name and Number: | Single/Multiple Component Metallic Bone<br>Fixation Appliances and Accessories (21 CFR<br>888.3030) |
| Regulatory Class: | II |
| Predicate Devices: | Ethi-Pack Surgical Stainless Steel Suture<br>(K931271) |
| | Pioneer Silicoat Sternal Cable (K993286) |
| | PectoFix DSF System (K000694) |
| | Synthes Sternal Fixation System<br>(K010943) |
| | Synthes (USA) Sterile Sternal Fixation System<br>(K050041) |
| | Sternal Band (K930015) |
| | Lorenz Sternal Closure System (K033740) |

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

051165

Intended Use:

Device

Description:

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

The KLS-Martin Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw.

The KLS Martin Sternal Talon is manufactured from TI-6AL-4V Titanium Alloy

Technological Characteristics:

#### Similarities to Predicate:

The KLS-Martin Sternal Talon is similar in intended use and indications for use as the Ethi-Pack Surgical Stainless Steel Suture (K931271), Pioneer Silicoat Stemal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Stemal Band (K930015), Lorenz Sternal Closure System (K033740) and KLS Martin Sternal Plating System (K032413)

## Differences to Predicate:

The KLS-Martin Sternal Talon is a two-piece interlocking system that does not utilize stainless steel sutures, titanium plates or titanium screws for fixation that are utilized in the Ethi-Pack Surgical Stainless Steel Suture C-2

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

(K931271), Pioneer Silicoat Sternal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Sternal Band (K930015), Lorenz Sternal Closure System (K033740) and KLS Martin Sternal Plating System (K032413). The KLS Martin Sternal Talon uses curved foot plates to apply pressure medially to ensure fixation.

### Substantial Equivalence:

The KLS-Martin Sternal Talon is substantially equivalent in intended use and indications for use as the Ethi-Pack Surgical Stainless Steel Suture (K931271), Pioneer Silicoat Sternal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Sternal Band (K930015), Lorenz Sternal Closure System (K033740) and KLS Martin Sternal Plating System (K032413)

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

SEP - 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Rc: K051165

Trade/Device Name: KLS Martin Sternal Talon Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: June 16, 2006 Received: June 20, 2006

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 r rease of a result 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.

{4}------------------------------------------------

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/industry/support/index.html.

Sincerely yours,

Barbara Brudno

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

Enclosure

{5}------------------------------------------------

## Indications for Use

051165

510(k) Number (if known):

KLS Martin Sternal Talon Device Name:

Indications For Use:

The KLS-Martin Sternal Talon 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 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aulana buclins for Mayn
(Division Sign Off)

(Division Sign-Off Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K051145
B-1