The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

Device Description

The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).

AI/ML Overview

The provided FDA 510(k) clearance letter for the KLS Martin Ixos System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for an AI/software device.

This document describes a metallic bone fixation appliance, not a software or AI medical device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Performance Data: Not Applicable" and details mechanical performance testing (in accordance with ASTM F382) and MR compatibility testing (per various ASTM standards). These are standard tests for orthopedic implants to demonstrate their static and dynamic strength, and safety in an MRI environment.

Therefore, I cannot extract the following information as it is not present in the provided text:

A table of acceptance criteria and the reported device performance (for AI/software).
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth
Adjudication method
If a multi-reader multi-case (MRMC) comparative effectiveness study was done
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate orthopedic implants based on:

Same intended use/indications for use.
Similar technological characteristics: manufactured from the same materials (Ti-6Al-4V), using the same manufacturing methods, and having similar principles of operation.
Performance data: Non-clinical comparative static and dynamic mechanical performance testing against a secondary predicate (Stryker VariAx 2 distal radius plates) and MR compatibility testing.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone plate system), not an AI/software device, and thus does not include the type of performance evaluation details (e.g., ground truth, reader studies, training data) relevant to AI/software.

Summary

FDA 510(k) Clearance Letter - KLS Martin Ixos System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 15, 2025

KLS Martin L.P.
Susan Leander
Regulatory Affairs Project Supervisor
11201 Saint Johns Industrial Pkwy S
Jacksonville, Florida 32246

Re: K250620
Trade/Device Name: KLS Martin Ixos 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, HWC
Dated: February 28, 2025
Received: July 18, 2025

Dear Susan Leander:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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K250620 - Susan Leander Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K250620 - Susan Leander Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, M.S.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Submission Number (if known): K250620

Device Name: KLS Martin Ixos System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) #: K250620

510(k) Summary

Prepared on: 2025-07-18

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	KLS Martin L.P.
Applicant Address	11201 Saint Johns Industrial Pkwy S Jacksonville FL 32246 United States
Applicant Contact Telephone	800-625-1557
Applicant Contact	Ms. Melissa Bachorski
Applicant Contact Email	rapm_na@klsmartin.com
Correspondent Name	KLS Martin L.P.
Correspondent Address	11201 Saint Johns Industrial Pkwy S Jacksonville FL 32246 United States
Correspondent Contact Telephone	800-625-1557
Correspondent Contact	Ms. Susan Leander
Correspondent Contact Email	rapm_na@klsmartin.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	KLS Martin Ixos System
Common Name	Single/multiple component metallic bone fixation appliances and accessories
Classification Name	Plate, Fixation, Bone
Regulation Number	888.3030
Product Code(s)	HRS, HWC (CLASS 2) - SCREW, FIXATION, BONE

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K222624	KLS Martin LINOS Wrist System	HRS
K212581	Stryker VariAx 2 Distal Radius & VariAx 2 Distal Ulna	HRS

Device Description Summary

21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use of the subject and primary predicate device are identical.

Technological Comparison

21 CFR 807.92(a)(6)

SIMILARITIES TO PRIMARY PREDICATE

The subject and predicate devices have the same fundamental technologies in that they are all designed for the internal fixation, alignment, stabilization, and reconstruction of the distal radius and/or ulna. They are manufactured from the same materials using the same manufacturing methods. All plates are pre-contoured to accommodate patient anatomy.

The device has the same technological characteristics (i.e., design, material, chemical composition, principle of operation, energy source, etc.) as the primary predicate device, K222624 LINOS Wrist System.

DIFFERENCES FROM PRIMARY PREDICATE

The only difference between the subject and predicate devices are the implant shapes. The subject devices are the dorsal/dorsolateral straight or L-shaped plates and the ulna T-shaped plate. The predicate devices have a variety of designs, including palmar radius plates, ulnar plates, dorsal and dorsolateral plates. The subject device plates include Magnetic Resonance (MR) Conditional labeling for use in an MR environment.

CONCLUSIONS

The KLS Martin Ixos system has the same intended use and the same technological characteristics as the primary predicate device, the KLS Martin LINOS Wrist System. Non-clinical testing demonstrates that the subject device is as safe, as effective, and performs as well as or better than the primary and secondary predicates.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

NON-CLINICAL PERFORMANCE DATA

Comparative static and dynamic mechanical performance testing of the subject device and the secondary predicate device were completed in accordance with ASTM F382 Standard Specifications and Test Methods for Metallic Bone Plates. MR compatibility testing was conducted (per ASTM F2052, ASTM F2119, ASTM F2182, and ASTM F2213) and accompanying rationale was provided to demonstrate MR Conditional parameters of the subject device.

CLINICAL PERFORMANCE DATA

Not Applicable

CONCLUSIONS

The results of comparative static and dynamic performance testing show that the KLS Martin Ixos DL4 plates perform as well or better than the secondary predicate, the Stryker VariAx 2 distal radius plates.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.