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

Device Description

The KLS Martin LINOS Wrist System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, reconstructive osteotomies of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V or CP Titanium. Plates are pre-contoured to accommodate patient anatomy and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants.

AI/ML Overview

This document is a 510(k) summary for the KLS Martin LINOS Wrist System. It outlines the device's characteristics, intended use, and compares it to legally marketed predicate devices to demonstrate substantial equivalence.

Here's an analysis of the provided text in relation to acceptance criteria and study proving device performance:

Crucially, this document does not describe an AI/ML medical device. It describes a traditional Class II orthopedic implant (metallic bone fixation appliance). Therefore, many of the typical acceptance criteria and study aspects for AI/ML devices (like MRMC studies, ground truth establishment for algorithms, training/test set sizes for algorithms, expert adjudication methods for AI performance, etc.) are not applicable to this submission.

The acceptance criteria and study described here are for the mechanical and biocompatibility performance of a physical medical device.

Acceptance Criteria and Device Performance (for a physical orthopedic implant)

Since this is a physical medical device and not an AI/ML algorithm, the "acceptance criteria" table below reflects the types of performance metrics that would be relevant for such a device, and how its performance is typically proven.

Acceptance Criteria Category	Specific Acceptance Criteria (Generalized for Orthopedic Implants)	Reported Device Performance (from the document)
Mechanical Performance	Equivalent or superior static and dynamic strength compared to predicate device.	"Comparative head-to-head static and dynamic bench testing was conducted on the subject and predicate...to determine that the subject device has equivalent performance to the primary predicate." "Mechanical test results demonstrate that the KLS Martin LINOS Wrist System's performance is substantially equivalent to the primary predicate device."
Screw Performance	Equivalent or superior torsional strength, drive torque, and pullout strength compared to predicate.	"Additionally, comparative screw testing was performed to evaluate torsional strength, drive torque, and pullout strength in accordance with ASTM F543." (Implicitly, the results met the equivalence standard for substantial equivalence).
Biocompatibility	Device materials are biocompatible and appropriate for intended use.	"Biological safety risk assessments in compliance with ISO 10993-1:2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use."
Sterilization	Sterilization process validated to achieve required sterility assurance level.	"The gamma sterilization process for the sterile implants and instrumentation/accessories was validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2012 using the VDmax25 method. The validation was also in accordance with ISO 11737-1:2018 and ISO 11737-2:2019." "The dynamic-air-removal steam sterilization cycle parameters for the non-sterile implants and non-sterile instrumentation/accessories were validated in accordance with ISO 17665-1:2006/(R)2013."
Endotoxin Level	Device meets pyrogen limit specifications.	"LAL endotoxin testing was conducted to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications in accordance with AAMI ANSI ST72: 2019."
Packaging Integrity	Packaging maintains sterility and protects device over shelf life.	"Packaging validations were performed for the PETG blister pack with 1073B Tyvek cover in accordance with ISO 11607-1:2019, ISO 11607-2:2019, and ASTM D4169:2016."
Shelf Life	Proven shelf life for sterile components.	"Shelf life for all gamma sterilized components is five (5) years from the date of sterilization."

Study Information (as applicable to a non-AI/ML medical device 510(k))

Since the provided document is a 510(k) summary for a physical orthopedic implant, not an AI/ML device, many of the requested points below (especially those related to AI/ML specific studies like MRMC or standalone algorithm performance) are not applicable or are addressed by the foundational regulatory framework for traditional medical devices.

Sample size used for the test set and the data provenance:
- Test Set (for mechanical testing): The document states "Comparative head-to-head static and dynamic bench testing was conducted on the subject and predicate...". It doesn't specify the exact sample size (N number of implants tested), but standard mechanical testing for medical devices typically involves a statistically robust number of samples to demonstrate equivalence or superiority according to relevant ISO/ASTM standards.
- Data Provenance: The studies are bench tests conducted in a laboratory setting, not on patient data. Thus, "country of origin of the data" or "retrospective/prospective" clinical study design are not relevant in this context. The "data" are mechanical test results.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical implant device proving mechanical performance, "ground truth" is established by adherence to recognized engineering standards (ASTM, ISO) for material properties, mechanical strength, and biocompatibility. Experts involved would be engineers, material scientists, and toxicologists conducting the tests and interpreting results against these standards, not clinicians establishing "ground truth" on patient images or outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is critical for establishing ground truth in clinical data, especially for AI/ML devices where reader variability exists. For mechanical bench testing, results are objective measurements against defined criteria and standards; adjudication of "readings" is not relevant.
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:
- Not Applicable. This is a type of study specifically for evaluating the performance of AI/ML diagnostic or prognostic tools when used by human readers (e.g., radiologists interpreting images). The KLS Martin LINOS Wrist System is a surgical implant; it does not involve diagnostic image interpretation or AI assistance for human readers.
- The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This reinforces that the evaluation was based on non-clinical (bench) testing.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. Again, this pertains to an AI/ML algorithm's performance. The device is a physical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this physical medical device, "ground truth" for proving substantial equivalence relies on:
  - Standardized Mechanical Test Results: Comparing the device's measured mechanical properties (strength, torque, pullout) to those of the predicate device, as defined by ASTM and ISO standards.
  - Biocompatibility Standards (ISO 10993-1:2018): Ensuring the materials meet safety criteria for biological interaction.
  - Sterilization Standards (ISO 11137, ISO 17665): Demonstrating the effectiveness of the sterilization process.
  - Packaging Standards (ISO 11607, ASTM D4169): Verifying package integrity and shelf life.
The sample size for the training set:
- Not Applicable. This concept is for AI/ML models. This device does not use a training set.
How the ground truth for the training set was established:
- Not Applicable. This concept is for AI/ML models. This device does not use a training set.

Summary

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May 25, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

KLS-Martin L.P. Liza Gordillo Regulatory Affairs Project Manager 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246

Re: K222624

Trade/Device Name: KLS Martin LINOS Wrist 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 Dated: April 25, 2023 Received: April 25, 2023

Dear Liza Gordillo:

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. 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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Shumaya Ali-S

Shumaya Ali, M.P.H. 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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Indications for Use

Submission Number (if known)

K222624

Device Name

KLS Martin LINOS Wrist 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)

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510(k) #: K222624

510(k) Summary

Prepared on: 2023-05-25

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 UnitedStates
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 UnitedStates
Correspondent Contact Telephone	800-625-1557
Correspondent Contact	Ms. Liza Gordillo
Correspondent Contact Email	liza.gordillo@klsmartin.com
Device Name21 CFR 807.92(a)(2)
Device Trade Name	KLS Martin LINOS Wrist System
Common Name	Plate, Fixation, Bone (primary); Screw, Fixation, Bone
Classification Name	Single/multiple component metallic bone fixation appliances andaccessories (primary)
	Smooth or threaded metallic bone fixation fastener
Regulation Number	888.3030 (primary) / 888.3040
Product Code	HRS (primary) / HWC
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K142906	APTUS® Wrist 2.5 System	HRS
K171624	IXOS Radius Plate System (Reference Device)	HRS
K170124	KLS Martin Level One Hand Plating System (Reference Device)	HRS
K110 125	2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM (Refere	HRS

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VariAx 2 System, VariAx 2 Mini Fragment System (Reference Da

HRS

K191972

ARIX Wrist System (Reference Device)

Device Description Summary

Intended Use/Indications for Use

The KLS Martin LINOS Wrist System is indicated for use in forearm fractures, and arthrodeses. It is intended for adults, and children (2-12 vears) and adolescents (12-21 years) in which growth plates will not be crossed by fixation.

Indications for Use Comparison

The intended use of the subject device is identical to the primary predicate device, APTUS® Wrist 2.5 System (K142906). The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and validation testing.

Technological Comparison

Similarities to Predicates

The subject and predicate devices, as well as the reference devices, have the same fundamental technologies in that they are all designed for use in surgical procedures of the hand and forearm region and are manufactured in a variety of sizes and configurations to provide the physician with various sizing options to repair hand and forearm fractures, osteotomies, and arthrodeses.

Differences from Predicate

The subject device is manufactured from CP titanium (ASTM F67:2017) and Ti-6Al-4V (ASTM F136:2013), while the predicate device, K142906, is manufactured from CP titanium (ASTM F67:2017), the reference device, K171624, is made of CP titanium (ASTM F67:2017) and the reference device, K170124, is made of both CP titanium (ASTM F136:2017) and Ti-6Al-4V (ASTM F136:2013). Performance testing demonstrated that the differences in material does not affectiveness of the subject devices and can be determined substantially equivalent.

Conclusion

Based on the questions above as well as conformance to FDA-recognized standards, along with the performance data compared with the predicate, K142906, safety and effectiveness has been demonstrated.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-Clinical Performance Data

Comparative head-to-head static and dynamic bench testing was conducted on the subject and predicate (Medartis AG APTUS Wrist 2.5 System (KI 42906)) devices to determine that the subject device has equivalent performance to the primary predicate. Additionally, comparative screw testing was performed to evaluate torsional strength, drive torque, and pullout strength in accordance with ASTM F543. Mechanical test results demonstrate that the KLS Martin LINOS Wrist System's performance is substantially equivalent to the primary predicate device. Biological safety risk assessments in compliance with ISO 10993-1 :2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use.

The gamma sterilization process for the sterile implants and instrumentation/accessories was validated in accordance with ISO 11137-1:2006 and ISO 11137-2:2012 using the VDmax25 method. The validation was also in accordance with ISO 11737-1:2018 and ISO 11737-2:2019. The dynamic-air-removal steam sterilization cycle parameters for the non-sterile implants and non-sterile instrumentation/accessories were validated in accordance with ISO 17665-1 :2006/(R)2013.

Shelf life for all gamma sterilized components is five (5) years from the date of sterilization.

LAL endotoxin testing was conducted to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications in accordance with AAMI ANSI ST72: 2019.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(4)

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Packaging validations were performed for the PETG blister pack with 1073B Tyvek cover in accordance with ISO 11607-1:2019, ISO 11607-2:2019, and ASTM D4169:2016

Clinical Performance Data

Clinical testing was not necessary for the determination of substantial equivalence.

Conclusions

The KLS Martin LINOS Wrist System has the same intended use and similar technological characteristics as the predicate device and reference devices. Technological differences have been addressed through performance data from the predicate and reference devices, in addition to analysis of peer-reviewed clinical studies. All information provided show the safe and effective use of the subject device for the intended patient population.

In conclusion, the potential benefits associated with the use of the subject device outweigh its potential risks for the targeted patient population. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.

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.