(55 days)
No
The device description and intended use clearly describe a mechanical bone screw system and associated plates. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The performance studies focus on mechanical and MRI compatibility testing, not algorithmic performance.
Yes
The device is described as an "internal bone fixation" system used for "bone fractures, fusions, osteotomies and non-unions," indicating its use in treating and repairing medical conditions.
No
The device, the Arthrex VAL and VAL KreuLock™ Compression Screw System, is intended for internal bone fixation for fractures, fusions, osteotomies, and non-unions. It is a treatment device, not one used to diagnose conditions.
No
The device description clearly states it is a "fracture fixation device system comprised of titanium... self-tapping, solid, fully threaded, variable angle locking (VAL) screws". This describes physical hardware, not software.
Based on the provided text, 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 performed directly on the patient's body.
- Device Description: The device is described as a "fracture fixation device system comprised of titanium... self-tapping, solid, fully threaded, variable angle locking (VAL) screws". This is a physical implant used to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The Arthrex VAL KreuLock™ Compression Screws (2.0-3.0 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, clavicle and scapula. 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 Hybrid 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 Hybrid Low Profile VAL Screws (3.5mm 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, 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
HRS, HWC
Device Description
The Arthrex VAL and VAL KreuLock™ Compression Screw System is a fracture fixation device system comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking (VAL) screws that are offered in standard and hybrid configurations. The Arthrex VAL KreuLock™ Compression Screws are offered in 2.0, 2.7 and 3.0 diameters and range in lengths from 6 mm to 80 mm. The Arthrex Hybrid KreuLock™ Compression Screws and Hybrid Low Profile VAL Screws consist of line extension screws with the locking head geometry of the existing 2.7 mm screws and a shaft geometry of the existing 3.5 mm screws. The Arthrex Hybrid KreuLock™ Compression Screws range in lengths from 12 mm to 80 mm and the Arthrex Hybrid Low Profile VAL Screws range in lengths from 10 mm to 80 mm. Arthrex VAL and VAL KreuLock™ Compression Screw System consist of single-use, non-sterile devices intended for end-user sterilization. The Arthrex VAL and VAL KreuLock Compression Screw System can be used with plating systems cleared in the following 510(k)s.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, clavicle, scapula, olecranon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 pull-out testing, torsional strength testing, and driving torque testing in accordance with ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws, as well as axial pull-out analysis, on the proposed Arthrex VAL and VAL KreuLock™ Compression Screw Systems to demonstrate that the proposed devices are substantially equivalent to the primary predicate devices.
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)
K201132, K220937, K203294, K103705, K082516
Reference Device(s)
K040907, K123241, K141478, K150456, K151732, K191344, K193345, K201235, K203834, K213837, K220937
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol representing the Department of Health & Human Services on the left, and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in a sans-serif font, with "FDA" in a blue square and the rest of the text in blue as well.
October 21, 2024
Arthrex, Inc. Konrad Wolfmeyer Regulatory Affairs Senior Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K242554
Trade/Device Name: Arthrex VAL and VAL KreuLock™ Compression Screw 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: August 27, 2024 Received: August 27, 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 (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 (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 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 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-regulatory
2
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, MS 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 (2.0-3.0 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, clavicle and scapula. 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 Hybrid 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 Hybrid Low Profile VAL Screws (3.5mm 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, 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.
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."
4
510(k) Summary
| Date Prepared | October 18, 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 | Plate, Fixation, Bone (primary) | |
| Screw, Fixation, Bone | ||
| Product Code | HRS (primary) | |
| HWC | ||
| Classification Name | 21 CFR 888.3030 Single/multiple component metallic bone | |
| fixation appliances and accessories (primary) | ||
| 21 CFR 888.3040 Smooth or threaded metallic bone fixation | ||
| fastener | ||
| Regulatory Class | II | |
| Primary Predicate Device | K201132 Arthrex Compression Screws | |
| Additional Predicate | ||
| Devices | K220937 Arthrex Mini Fragment System | |
| K203294 Arthrex Pilon Fusion System | ||
| K103705 Arthrex Low Profile Screws | ||
| 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 and VAL KreuLock™ Compression Screw | |
| System is a fracture fixation device system comprised of | ||
| titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, | ||
| solid, fully threaded, variable angle locking (VAL) screws that | ||
| are offered in standard and hybrid configurations. The | ||
| Arthrex VAL KreuLock™ Compression Screws are offered in | ||
| 2.0, 2.7 and 3.0 diameters and range in lengths from 6 mm to | ||
| 80 mm. The Arthrex Hybrid KreuLock™ Compression Screws | ||
| and Hybrid Low Profile VAL Screws consist of line extension | ||
| screws with the locking head geometry of the existing 2.7 | ||
| mm screws and a shaft geometry of the existing 3.5 mm | ||
| screws. The Arthrex Hybrid KreuLock™ Compression Screws | ||
| range in lengths from 12 mm to 80 mm and the Arthrex | ||
| K040907 | Arthrex Small Fragment Plates and Screws | |
| K123241 | Arthrex Fracture Plates | |
| K141478 | Arthrex Fracture Plates and Screws | |
| K150456 | Arthrex Plates, Screws, and Staples | |
| K151732 | Arthrex Fracture Plates | |
| K191344 | Mini Comprehensive Fixation System | |
| K193345 | Arthrex DynaNite Compression Plate | |
| K201235 | Arthrex MaxForce MTP Compression Plates and Screws | |
| K203834 | Arthrex Patella SuturePlate | |
| K213837 | Arthrex Fracture Plates | |
| K220937 | Arthrex Mini Fragment System | |
| se | The Arthrex VAL KreuLock™ Compression Screws (2.0-3.0 mm solid) are intended to be used in a plate-screw system | |
| Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle | ||
| Fusion Plates. | ||
| The Arthrex Hybrid Low Profile VAL Screws (3.5mm 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 pull-out testing, torsional strength | |
| testing, and driving torque testing in accordance with ASTM | ||
| F543 Standard Specification and Test Methods for Metallic | ||
| Medical Bone Screws, as well as axial pull-out analysis, on the | ||
| proposed Arthrex VAL and VAL KreuLock™ Compression | ||
| Screw Systems to demonstrate that the proposed devices are | ||
| substantially equivalent to the primary predicate devices. | ||
| 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 has the same intended use/indications, fundamental | ||
| scientific technology, materials, sterility, and packaging | ||
| method as the predicate devices cleared via K220937, | ||
| K201132, K203294, K103705, and K082516. | ||
| Conclusion | Based on the intended use, fundamental scientific | |
| technology, and the data provided in this Traditional | ||
| 510(k), Arthrex has determined that the Arthrex VAL and VAL | ||
| KreuLock™ Compression Screw System is substantially |
5
Hybrid Low Profile VAL Screws range in lengths from 10 mm to 80 mm. Arthrex VAL and VAL KreuLock™ Compression Screw System consist of single-use, non-sterile devices intended for end-user sterilization.
The Arthrex VAL and VAL KreuLock Compression Screw System can be used with plating systems cleared in the following 510(k)s.
Indications for Us 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, clavicle and scapula. 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 Hybrid 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
6
7
| 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. |