The Arthrex VAL KreuLock™ Compression Screws (2.7 mm solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7) and Distal Radius Plates.

The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex VAL Screws (2.7 mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions, in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.

The Arthrex VAL Screws (3.5 mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

Device Description

The Arthrex SS VAL KreuLock™ Compression Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The screws are sold single-use and non-sterile.

The Arthrex SS VAL Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 8 mm to 110 mm. The screws are sold single-use and non-sterile.

AI/ML Overview

The provided text describes mechanical performance testing for a medical device and not an AI/ML powered device, therefore the information required to answer the questions for an AI/ML powered device is not available.

The device in question, the "Arthrex SS VAL and VAL KreuLock™ Compression Screw System," is a physical medical device (fracture fixation screws) and the performance data described relates to mechanical properties (pull-out, compression, torque, etc.) and MRI compatibility. There is no mention of any AI/ML components, software algorithms, or clinical performance metrics typically associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of AI/ML, nor can I answer questions regarding sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for a training set was established. These categories are specifically designed for the evaluation of AI/ML-powered devices.

Summary

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January 10, 2025

Arthrex, Inc. Konrad Wolfmeyer Regulatory Affairs Senior Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K243195

Trade/Device Name: Arthrex SS VAL and VAL KreuLock™ Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 30, 2024 Received: October 1, 2024

Dear Konrad Wolfmeyer:

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.

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"

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(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 OS 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 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-reportingcombination-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 Rue"). 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-advicecomprehensive-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-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

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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)

K243195

Device Name

Arthrex SS VAL and VAL KreuLock™ Compression Screw System

Indications for Use (Describe)

The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

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.

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510(k) Summary

Date Prepared	01/08/2025
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Name: Konrad WolfmeyerTitle: Senior Regulatory Affairs SpecialistPhone: 1-317-607-4265Email: Konrad.Wolfmeyer@arthrex.com
Trade Name	Arthrex SS VAL and VAL KreuLock™ Compression Screw System
Common Name	Arthrex SS VAL and VAL KreuLock™ Compression Screw System
Product Code	HWC
Classification Name	21 CFR 888.3040 Screw, Fixation, Bone
Regulatory Class	II
Primary Predicate Device	K201132 Arthrex Compression Screws
Additional Predicate Devices	K103705 Arthrex Low Profile Screws
Reference Devices	K082516 Smith & Nephew PERI-LOC Hexalobular Bone Screws
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex SS VAL and VAL KreuLock™ Compression Screw System
Device Description	The Arthrex SS VAL KreuLock™ Compression Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The screws are sold single-use and non-sterile.The Arthrex SS VAL Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 8
	mm to 110 mm. The screws are sold single-use and non-sterile.
Indications for Use	The Arthrex VAL KreuLock™ Compression Screws (2.7mm solid) are intended to be used in a plate-screwsystem for internal bone fixation for bone fractures,fusions, osteotomies and non-unions in the ankle, foot,hand, wrist, tibia, fibula, femur, pelvis, acetabulum,metacarpals, metatarsals, humerus, radius, ulna,calcaneus, and clavicle. When used with a plate, thescrew may be used with the Arthrex Low Profile Plate,Small Fragment Plates, Distal Extremity Plates, MeshPlates (2.7) and Distal Radius Plates.
	The Arthrex VAL KreuLock™ Compression Screws (3.5mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bonefractures, fusions, Osteotomies and non-unions in theankle, foot, hand, wrist, clavicle, scapula, olecranon,humerus, radius, ulna, tibia, calcaneus, pelvis,acetabulum, metacarpals, metatarsals, femur andfibula. When used with a plate, the screws may be usedwith the Arthrex Low Profile Plate, Small FragmentPlates, Fracture Plates, Distal Extremity Plates, DistalRadius Plates, Humeral Fracture Plates, OsteotomyPlates, and Ankle Fusion Plates.
	The Arthrex VAL Screws (2.7 mm solid) are intended tobe used as stand-alone bone screws, or in a plate-screwsystem for internal bone fixation for bone fractures,fusions, osteotomies and non-unions in the ankle, foot,hand, wrist, tibia, fibula, femur, pelvis, acetabulum,metacarpals, metatarsals, humerus, radius, ulna,calcaneus, and clavicle. When used with a plate, thescrew may be used with the Arthrex Low Profile Plate,Small Fragment Plates, Distal Extremity Plates, MeshPlates (2.7) and Distal Radius Plates.
	The Arthrex VAL Screws (3.5 mm and larger, solid) areintended to be used as stand-alone bone screws, or in a
	plate-screw system for internal bone fixation for bonefractures, fusions, osteotomies and non-unions in theankle, foot, hand, wrist, clavicle, scapula, olecranon,humerus, radius, ulna, tibia, calcaneous, pelvis,acetabulum, metacarpals, metatarsals, femur andfibula. When used with a plate, the screws may be usedwith the Arthrex Low Profile Plate, Small FragmentPlates, Fracture Plates, Distal Extremity Plates, DistalRadius Plates, Humeral Fracture Plates, OsteotomyPlates, and Ankle Fusion Plates.
Performance Data	Arthrex conducted pull-out testing, compressiontesting, torque testing, axial pull-out analysis, torsionalstrength testing, and driving torque testing conductedin accordance with ASTM F543 Standard Specificationand Test Methods for Metallic Medical Bone Screws onthe proposed Arthrex SS VAL and VAL KreuLock™Compression Screw Systems to demonstrate that thechange do not affect performance and the proposeddevices are substantially equivalent to the primarypredicate devices.
	MRI force, torque, and image artifact testing wereconducted in accordance with FDA guidance Testingand Labeling Medical Devices for Safety in the MagneticResonance (MR) Environment, ASTM F2052 StandardTest Method for Measurement of Magnetically InducedDisplacement Force on Medical Devices in the MagneticResonance Environment, ASTM F2119 Standard TestMethod for Evaluation of MR Image Artifacts fromPassive Implants, ASTM F2182 Standard Test Methodfor Measurement of Measurement of Radio FrequencyInduced Heating Near Passive Implants During MagneticResonance Imaging and ASTM F2213 Standard TestMethod for Measurement of Magnetically InducedTorque on Medical Devices in the Magnetic ResonanceEnvironment.
Technological Comparison	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System is substantially equivalent to thepredicate devices cleared under K201132 in which the


	basic design features, fundamental scientifictechnology, materials, shelf-life (non-sterile only), andsterility (non-sterile only) are identical.
	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System is manufactured from stainless steel,which is the same material as the primary predicatecleared under K201132.
	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System devices have the same sterility, non-sterile, as the primary predicate cleared under K201132.
	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System devices have the same packaging as theprimary predicate cleared under K201132.
	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System devices have the same shelf-life as theprimary predicate cleared under K201132.
	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System devices have the same fundamentalscientific technology as the primary predicate clearedunder K201132.
	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System devices were evaluated for MRIConditional labeling, which is the same as the primarypredicate cleared under K201132.
	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System devices have an indications for use thatdiffers from the primary predicate cleared underK201132.
	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System is offered in lengths outside of theprimary predicate range cleared under K201132.
	The Arthrex SS VAL and VAL KreuLock™ CompressionScrew System is substantially equivalent to the predicatedevices cleared under K201132. Any differences betweenthe Arthrex SS VAL and VAL KreuLock™ CompressionScrew System and the predicate device cleared underK201132 are considered minor and do not raise differentquestions of safety or effectiveness.
Conclusion	Based on the intended use, fundamental scientifictechnology, and the data provided in this thisTraditional 510(k), Arthrex has determined that theArthrex SS VAL and VAL KreuLock™ Compression ScrewSystem is substantially equivalent to the predicatedevices. Any differences between the proposed andpredicate devices are considered minor and do not raisedifferent questions concerning safety and effectiveness.

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.