K032442: The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.

K971297: The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid i internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference.

K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillocranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.

K944561: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.

Device Description

The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and diameter and stainless steel sonotrode tips that are provided in sterile packaging.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the KLS Martin Rigid Fixation - Sterile device:

This submission is for a medical device (bone plate, screws, drills, and sonotrode tips) provided in sterile packaging, not a software or AI/ML-based device. Therefore, many of the requested categories related to algorithm performance, training sets, and expert adjudication are not applicable.

The primary "study" in this context is the demonstration of substantial equivalence to predicate devices, focusing on the new aspect of sterile packaging and sterilization method.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Sterilization Method (Gamma Radiation)	Identical to cleared Resorb-X Resorbable Plating System (K011590).	This demonstrates the sterile packaging and sterilization method meets the standard set by a previously cleared device.
Manufacturing and Design	Identical to KLS-Martin Mandibular/Reconstruction System II (K032442), Centre-Drive Drill-Free Screw (K971297), Micro Osteosynthesis System (1.0) (K944561), and KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565).	This indicates that the core mechanical components are unchanged from previously cleared devices, thus their performance characteristics are presumed to be the same.
Intended Use	Provides KLS Martin's osteosynthesis products in sterile packaging. Does not change the already cleared intended use of the component parts.	The sterilization process is not intended to alter the therapeutic or diagnostic function of the device but merely to deliver it in a sterile state.
Packaging (to identify sterile product)	Different stock numbers from originally cleared stock numbers to identify the product as sterile.	This is an administrative control to ensure proper identification of the sterile version. No performance criteria are associated with this beyond clear labeling.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as this is a medical device (hardware) submission, not a software or AI/ML device requiring a test set of data. The "test" here refers to demonstrating manufacturing and sterilization equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. Ground truth as typically understood for AI/ML models is not relevant here. The "ground truth" for the device's functionality and safety is established through the previous clearance of the predicate devices and the validation of the sterilization process.

4. Adjudication Method for the Test Set

This is not applicable. There's no "test set" in the context of adjudication for AI/ML performance.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is a hardware medical device; it does not involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a hardware medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Previous FDA clearances: The KLS Martin Rigid Fixation - Sterile components (plates, screws, drills) have established safety and effectiveness through prior FDA clearances (K032442, K971297, K944561, K944565).
Validated Sterilization Process: The sterilization method (gamma radiation) is considered "substantially equivalent" to one previously cleared (Resorb-X Resorbable Plating System K011590), implying its effectiveness in achieving sterility is already established.

8. The Sample Size for the Training Set

This is not applicable as this is not an AI/ML or software device.

9. How the Ground Truth for the Training Set was Established

This is not applicable as this is not an AI/ML or software device.

Summary

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

APR 1 8 2006

K060177

ﺎ

kıs martın.ı.p.

510(K) SUMMARY

Submitter:	KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378
Contact Person:	Jennifer DamatoDirector RA/QA
Date of Summary:	12 January 2006
Device Name:	KLS Martin Rigid Fixation- Sterile
Trade Name:	Sterile Packaged Rigid Fixation
Common Name:	Bone Plate
ClassificationName and Number:	Bone Plate (CFR 872.4760)
Regulatory Class:	II
Predicate Devices:	KLS-Martin Mandibular/Reconstruction System II (K032442)Resorb-X Resorbable Plating System (K011590)Centre-Drive Drill-Free Screw (K971297)Micro Osteosynthesis System (1.0) (K944561)KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565)
DeviceDescription:	The KLS Martin Rigid Fixation - Sterile includestitanium plates of various shapes and thickness,titanium screws of various length and diameter,stainless steel twist drills of various length anddiameter and stainless steel sonotrode tips that areprovided in sterile packaging.

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Intended Use:

The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's osteosynthesis products in sterile packaging. These products have been previously cleared for sale and providing them sterile does not change the already cleared intended use.

Technological Characteristics:

Similarities to Predicate

KLS Martin Rigid Fixation - Sterile is identical in manufacturing and design to the KLS-Martin Mandibular/Reconstruction System II (K032442), Centre-Drive Drill-Free Screw (K971297) Micro Osteosynthesis System (1.0) (K944561) and KLS-Martin Micro Osteosythesis System(1.5mm) (K944565).

Sterilization method of the KLS Martin Rigid Fixation -Sterile will be by gamma radiation which is the exact same process as cleared in Resorb-X Resorbable Plating System (K011590)

Differences to Predicate

KLS Martin Rigid Fixation - Sterile will be packaged sterile and will have different stock numbers from originally cleared stock numbers to identify the product as sterile.

Substantial Equivalence:

KLS Martin Rigid Fixation - Sterile are substantially equivalent to the KLS-Martin Mandibular/Reconstruction System II (K032442), Centre-Drive Drill-Free Screw (K971297) Micro Osteosynthesis System (1.0) (K944561) and KLS-Martin Osteosythesis Micro System(1.5mm) (K944565).

KLS Martin Rigid Fixation - Sterile are substantially equivalent to the Resorb-X Resorbable Plating System (K011590) in packaging and sterilization methods.

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text around the perimeter appears to be the name of a government organization, possibly related to health or human services. The central symbol consists of three curved lines that resemble a stylized bird or abstract design. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2006

Ms. Jennifer Damato KLS Martin, L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K060177

Trade/Device Name: KLS Martin Rigid Fixation - Sterile Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: January 12, 2006 Received: January 23, 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 (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 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Will y Michael. Evils

Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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Indications for Use

510(k) Number (if known): K060177

Device Name: KLS Martin Rigid Fixation - Sterile

Indications for Use: KLS-Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use.

K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.

K032442: The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.

K971297: The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid i internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference.

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)

Susan Thorpe

Page 1 of

eneral Hos

K060172
4

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.