(89 days)
No
The device description and intended use clearly define the device as a mechanical bone screw system for fracture fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on mechanical and MRI compatibility testing, not algorithmic performance.
Yes.
The device is described as a "fracture fixation device" intended for "internal bone fixation for bone fractures, fusions, osteotomies and non-unions," which directly addresses and treats medical conditions.
No
Explanation: The device is described as a "fracture fixation device" and its intended use is "internal bone fixation" for bone fractures, fusions, osteotomies, and non-unions. This indicates a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states the device is comprised of titanium screws, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the screws are for "internal bone fixation for bone fractures, fusions, Osteotomies and non-unions." This is a surgical procedure involving the physical repair of bone, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "fracture fixation devices comprised of titanium... self-tapping, solid, fully threaded, variable angle locking screws." This description aligns with a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
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 (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.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS
Device Description
The Arthrex VAL KreuLock™ Compression Screws are fracture fixation devices comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking screws that are offered in standard and reinforced configurations. They are offered with a 3.5 mm diameter and the standard versions range in lengths from 10 mm to 90 mm while the reinforced versions range in lengths from 10 mm to 110 mm. The reinforced configurations have a larger minor diameter with the same major diameter as the standard configurations.
The Arthrex VAL Screws are fracture fixation devices comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking screws that are offered in standard and reinforced configurations. They are offered with a 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The reinforced configurations have a larger minor diameter with the same major diameter as the standard configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Arthrex conducted pullout testing, cantilever testing, pushout testing, head locking testing, compression testing, torque testing, axial pullout analysis, torsional strength testing, and driving torque testing was conducted in accordance with ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws on the proposed Arthrex VAL and VAL KreuLock™ Compression Screw Systems to demonstrate that the change do not affect performance and the proposed devices are substantially equivalent to the primary predicate device.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 31, 2024
Arthrex, Inc. Konrad Wolfmeyer Regulatory Affairs Senior Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K241592
Trade/Device Name: Arthrex 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. HRS Dated: May 31, 2024 Received: June 3, 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.
1
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 (OS) 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 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 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-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 medical devices and radiation-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
2
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,
Christopher Ferreira -S
Christopher Ferreria, 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
3
Indications for Use
Submission Number (if known)
Device Name
Arthrex 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.
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.
Type of Use (Select one or both, as applicable)
X 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 Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
4
K241592 510(k) Summary
| Date Prepared | August 29, 2024 | |
|---|---|---|
| Submitter | Arthrex Inc. | |
| 1370 Creekside Boulevard | ||
| Naples, FL 34108-1945 | ||
| Contact Person | Name: Konrad Wolfmeyer | |
| Title: Senior Regulatory Affairs Specialist Phone: 1- | ||
| 317-607-4265 | ||
| Email: Konrad.Wolfmeyer@arthrex.com | ||
| Trade Name | Arthrex VAL and VAL KreuLock™ Compression Screw | |
| System | ||
| Common Name | Arthrex 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 Device(s) | K103705 Arthrex Low Profile Screws | |
| K143614 Arthrex Low Profile VAL Screw | ||
| Reference Device | 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 VAL and | ||
| VAL KreuLock™ Compression Screw System | ||
| Device Description | The Arthrex VAL KreuLock™ Compression Screws are fracture | |
| fixation devices comprised of titanium (Titanium Ti-6AL-4V | ||
| per ASTM F1472) self-tapping, solid, fully threaded, variable | ||
| angle locking screws that are offered in standard and | ||
| reinforced configurations. They are offered with a 3.5 mm | ||
| diameter and the standard versions range in lengths from 10 | ||
| mm to 90 mm while the reinforced versions range in lengths | ||
| from 10 mm to 110 mm. The reinforced configurations have a | ||
| larger minor diameter with the same major diameter as the | ||
| standard configurations. | ||
| The Arthrex VAL Screws are fracture fixation devices comprised | ||
| of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, | ||
| solid, fully threaded, variable angle locking screws that are | ||
| offered in standard and reinforced configurations. They are | ||
| offered with a 3.5 | ||
| mm diameter and range in lengths from 10 mm to 110 | ||
| mm. The reinforced configurations have a larger minor | ||
| diameter with the same major diameter as the standard | ||
| configurations. | ||
| Indications for Use | 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 (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, 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. | ||
| Performance Data | Arthrex conducted pullout testing, cantilever testing, | |
| pushout testing, head locking testing, compression | ||
| testing, torque testing, axial pullout analysis, torsional | ||
| strength testing, and driving torque testing was | ||
| conducted in accordance with ASTM F543 Standard | ||
| Specification and Test Methods for Metallic Medical | ||
| Bone Screws on the proposed Arthrex VAL and VAL | ||
| KreuLock™ Compression Screw Systems to demonstrate | ||
| that the change do not affect performance and the | ||
| proposed devices are substantially equivalent to the | ||
| primary predicate device. | ||
| MRI force, torque, and image artifact testing were | ||
| conducted in accordance with FDA guidance Testing | ||
| and Labeling Medical Devices for Safety in the Magnetic | ||
| Resonance (MR) Environment, ASTM F2052 Standard | ||
| Test Method for Measurement of Magnetically Induced | ||
| Displacement Force on Medical Devices in the Magnetic | ||
| Resonance Environment, ASTM F2119 Standard Test | ||
| Method for Evaluation of MR Image Artifacts from | ||
| Passive Implants, ASTM F2182 Standard Test Method | ||
| for Measurement of Measurement of Radio Frequency | ||
| Induced Heating Near Passive Implants During Magnetic | ||
| Resonance Imaging and ASTM F2213 Standard Test | ||
| Method for Measurement of Magnetically Induced | ||
| Torque on Medical Devices in the Magnetic Resonance | ||
| Environment. | ||
| Technological Comparison | The Arthrex VAL and VAL KreuLock™ Compression Screw | |
| System is substantially equivalent to the predicate | ||
| devices cleared under K201132 in which the basic design | ||
| features, fundamental scientific technology, materials, | ||
| shelf-life (non-sterile only), and sterility (non-sterile | ||
| only) are identical. | ||
| The Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System is manufactured from titanium, which is the | ||
| same material as the primary predicate device cleared | ||
| under K201132. | ||
| The Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System devices have the same sterility, non-sterile, as | ||
| the primary predicate cleared under K201132. | ||
| The Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System devices have the same packaging as the primary | ||
| predicate cleared under K201132. | ||
| The Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System devices have the same shelf-life, unlimited, as | ||
| the primary predicate cleared under K201132. | ||
| The Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System devices have the same fundamental scientific | ||
| technology as the primary predicate cleared under | ||
| K201132. | ||
| The Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System devices were evaluated for MRI Conditional | ||
| labeling, which is the same as the primary predicate | ||
| cleared under K201132. | ||
| The Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System devices have an indications for use that differs | ||
| from the primary predicate cleared under K201132. | ||
| The Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System devices are offered in longer lengths than the | ||
| primary predicate cleared under K201132. | K241592 - Page 3 of 4 | |
| The Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System is substantially equivalent to the predicate devices | ||
| cleared under K201132. Any differences between the | ||
| Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System and the predicate device cleared under K201132 | ||
| are considered minor and do not raise different questions | ||
| of safety or effectiveness. | ||
| Conclusion | Based on the intended use, fundamental scientific | |
| technology, and the data provided in this this | ||
| Traditional 510(k), Arthrex has determined that the | ||
| Arthrex VAL and VAL KreuLock™ Compression Screw | ||
| System is substantially equivalent to the predicate | ||
| devices. Any differences between the proposed and | ||
| predicate devices are considered minor and do not raise | ||
| different questions concerning safety and effectiveness. |
5
6
...
7