KLS Martin Ixos System

K250620 · KLS Martin L.P. · HRS · Aug 15, 2025 · Orthopedic

Device Facts

• Record ID: K250620
• Device Name: KLS Martin Ixos System
• Applicant: KLS Martin L.P.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 15, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

KLS Martin Ixos System consists of metallic bone plates, screws, and locking pins for internal fixation, alignment, stabilization, and reconstruction of distal radius and/or ulna. Plates are pre-contoured to patient anatomy. Used by surgeons in clinical settings to treat fractures, osteotomies, and arthrodeses. Device provides mechanical stabilization of bone segments to facilitate healing. System includes necessary surgical instruments for implant placement. MR Conditional labeling included.

Clinical Evidence

No clinical data. Bench testing only. Comparative static and dynamic mechanical performance testing conducted per ASTM F382. MR compatibility testing performed per ASTM F2052, F2119, F2182, and F2213.

Technological Characteristics

Metallic bone fixation plates manufactured from Ti-6Al-4V. Pre-contoured design. Mechanical fixation principle. MR Conditional. Testing performed per ASTM F382 (mechanical), ASTM F2052, F2119, F2182, and F2213 (MR compatibility).

Indications for Use

Indicated for adults, adolescents (12-21), and children (2-12) with forearm fractures, osteotomies, or arthrodeses, provided growth plates are fused or not crossed by fixation.

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 LINOS Wrist System (K222624)
• Stryker VariAx 2 Distal Radius & VariAx 2 Distal Ulna (K212581)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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.

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

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K250620 - Susan Leander
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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
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

Submission Number (if known)

K250620

Device Name

KLS Martin Ixos System

Indications for Use (Describe)

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.

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)

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| 510(k) #: K250620 | 510(k) Summary | Prepared on: 2025-07-18 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| 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 | [e-mail] | |
| 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 | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| 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) |
| 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). | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |

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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.

**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.