KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE

K070169 · KLS Martin L.P. · HRS · Mar 26, 2007 · Orthopedic

Device Facts

• Record ID: K070169
• Device Name: KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE
• Applicant: KLS Martin L.P.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

K062857 KLS Martin Quick Disc is intended for use in the reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures. K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Device Story

Device consists of three metallic bone fixation systems: Quick Disc (cranial), Sternal Talon (sternal), and Sternal Plating System (sternal). Quick Disc: two-sided cranial closure device; lower disc attached to threaded post; upper disc threaded/locked to secure bone flap. Sternal Talon: two-piece clamping device; ratcheted locking system; interlocks on opposing sides of sternum; three-position screw for open/close/lock; emergency re-entry via cut points. Sternal Plating System: plates (1.0-3.0mm thick) and screws (2.3-3.2mm diameter). Used by surgeons in clinical settings for bone fixation. Sterile packaging provided to facilitate surgical workflow. Benefits include stabilized bone fixation and secure closure.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence based on identical materials, manufacturing, and design to predicate devices, with sterilization validation performed per established methods.

Technological Characteristics

Metallic bone fixation appliances. Quick Disc: two-sided disc/post mechanism. Sternal Talon: two-piece ratcheted clamping system. Sternal Plating: plates and screws. Sterilization: gamma radiation. Packaging: sterile.

Indications for Use

Indicated for patients requiring cranial bone flap reattachment, burr hole coverage, or cranial fracture fixation; and patients requiring stabilization/fixation of anterior chest wall fractures, including post-sternotomy or sternal reconstruction.

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 Quick Disc (K062857)
• KLS Martin Sternal Talon (K051165)
• KLS Martin Sternal Plating System (K032413)

Reference Devices

• KLS Martin Rigid Fixation - Sterile (K060177)

Submission Summary (Full Text)

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# kus martin L.P.

. 1999

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: 上一篇:

K070169

..

# 510(K) SUMMARY

MAR 2 6 2007

:

:

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| 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: | 5 March 2007 |
| Device Name: | KLS Martin Quick Disc, Sternal Talon and<br>Sternal Plating - Sterile |
| Trade Name: | KLS Martin Quick Disc, KLS Martin Sternal<br>Talon and KLS Martin Sternal Plating |
| Common Name: | KLS Martin Quick Disc - Plate, cranioplasty,<br>preformed, non-alterable |
| | KLS Martin Sternal Talon - Single/multiple<br>component metallic bone fixation appliances<br>and accessories |
| | KLS Martin Sternal Plating System -<br>Single/multiple component metallic bone<br>fixation appliances and accessories |
| Classification<br>Name and Number: | KLS Martin Quick Disc - 882.5330 Preformed<br>nonalterable cranioplasty plate (CFR<br>882.5330) |
| | KLS Martin Sternal Talon - Single/multiple<br>component metallic bone fixation appliances<br>and accessories (CFR 888.3030) |
| | KLS Martin Sternal Plating System -<br>Single/multiple component metallic bone<br>fixation appliances and accessories (CFR<br>888.3030) |

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Regulatory Class:

Predicate Devices:

Intended Use:

Device Description: ll

KLS Martin Quick Disc (K062857)

KLS Martin Sternal Talon (K051165)

KLS Martin Sternal Plating System (K032413)

KLS Martin Rigid Fixation - Sterile (K060177)

To offer KLS Martin Quick Disc, KLS Martin Sternal Talon and KLS Martin Sternal Plating System in sterile packaging with the following indications for use:

K062857 KLS Martin Quick Disc is intended for reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures.

K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for stabilization and fixation of antenor chest wall fractures including sternal fixation subsequent to stemotomy and sternal reconstructive procedures.

The KLS Martin Quick Disc is a two-sided cranial closure device. The lower disc is attached to a threaded post. The upper disc is threaded down and locked on the post securely holding the bone flap in place. The KLS Martin Quick Disc diameters range from 12mm to 22mm in size

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

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A second emergency re-entry is position. provided by cut points adjacent to the screw.

KLS - Martin Sternal Plating System consists of plates having a thickness from 1.0mm to 3.0mm and screws having a diameter of 2.3mm to 3.2mm.

#### Technological Characteristics:

### Similarities to Predicate

The KLS Martin Quick Disc, Sternal Talon and Sternal Plating System - Sterile are identical in manufacturing and materials as the KLS Martin Quick Disc (K062857), KLS Martin Sternal Talon (K051165) and KLS Martin Sternal Plating System (K032413).

The KLS Martin Quick Disc, Sternal Talon and Sternal Plating System - Sterile will be sterilized by gamma radiation and packaged in exactly the same manner as the KLS Martin Rigid Fixation - Sterile (K060177)

# Difference to Predicate

The KLS Martin Quick Disc, Sternal Talon and Sternal Plating System - Sterile will be packaged sterile and will have different stock numbers from originally cleared stock numbers to identify the product as sterile.

## Substantial Equivalence:

The KLS Martin Quick Disc, Sternal Talon and Plating System are substantially Sternal equivalent in manufacturing and materials to the KLS Martin Quick Disc (K062857), KLS Martin Sternal Talon (K051165), and KLS Martin Sternal Plating System (K032413) and in sterilization and packaging to the KLS Martin Rigid Fixation - Sterile (K060177)

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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 consists of a stylized depiction of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

MAR 2 6 2007

#### Re: K070169

Trade/Device Name: KLS Martin Sternal Talon and KLS Martin Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS

Trade/Device Name: KLS Martin Ouick Disc Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: March 5, 2007 Received: March 7, 2007

## 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.

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# Page 2 - Ms. Jennifer Damato

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.

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,

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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# Indications for Use

# 510(k) Number (if known): K070169

KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile Device Name:

Indications For Use: To offer KLS Martin Quick Disc, KLS Martin Sternal Talon and KLS Martin Sternal Plating in sterile packaging with the following indications for use:

> K062857 KLS Martin Quick Disc is intended for use in the reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures.

K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Prescription Use V (Part 21 CFR 801 Subparl 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)

Chlara Pnebun

and Ne

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510(k) Number K070164