Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
K260809 · Arthrex, Inc. · HWC · Jun 25, 2026 · Orthopedic
Device Facts
Record ID
K260809
Device Name
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
Applicant
Arthrex, Inc.
Product Code
HWC · Orthopedic
Decision Date
Jun 25, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3040
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
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 (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 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 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 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, 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 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. The Arthrex Low Profile 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 nonunions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates and Osteotomy Plates. The Arthrex Mini Fragment System is indicated for fracture fixation, reconstruction, replantation, stabilization, reduction, fusions, osteotomies, mal-unions, and non-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12-21 years) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Device Story
System of metallic bone fixation fasteners (screws) used for internal bone fixation; includes VAL (Variable Angle Locking), KreuLock, Hybrid, and Low Profile configurations; used as stand-alone screws or with compatible plates; operated by surgeons in clinical settings; provides mechanical stabilization of bone fractures, fusions, and osteotomies; sterile, single-use; benefits patient by facilitating bone healing through rigid fixation.
Clinical Evidence
No clinical data. Bench testing only; reliance on previously cleared predicate devices for fit, form, and function; sterilization validation performed.
Indicated for internal bone fixation (fractures, fusions, osteotomies, non-unions) in adult and adolescent (12-21 years) patients; applicable to various anatomical sites including ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, clavicle, scapula, and olecranon.
Regulatory Classification
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.
Predicate Devices
Arthrex SS VAL and VAL KreuLock Compression Screw System (K243195)
Arthrex VAL and VAL KreuLock Compression Screw System (K241592)
Arthrex VAL and VAL KreuLock Compression Screw System (K242554)
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FDA U.S. FOOD & DRUG ADMINISTRATION
June 25, 2026
Arthrex, Inc.
Konrad Wolfmeyer
Regulatory Affairs Senior Specialist
1370 Creekside Blvd.
Naples, Florida 34108
Re: K260809
Trade/Device Name: Arthrex Sterile 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: May 27, 2026
Received: May 27, 2026
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260809 - Konrad Wolfmeyer
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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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K260809 - Konrad Wolfmeyer
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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,
Tejen D. Soni -S
For
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
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K260809
?
Please provide the device trade name(s).
?
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
Please provide your Indications for Use below.
?
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 (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 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 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 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, 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.
Page 1 of 2
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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.
The Arthrex Low Profile 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 nonunions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates and Osteotomy Plates.
The Arthrex Mini Fragment System is indicated for fracture fixation, reconstruction, replantation, stabilization, reduction, fusions, osteotomies, mal-unions, and non-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12-21 years) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| --- | --- | --- |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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# 510(k) Summary
| ***Date Prepared*** | 6/23/2026 |
| --- | --- |
| ***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 Sterile VAL and VAL KreuLock™ Compression Screw System |
| ***Common Name*** | Smooth or threaded metallic bone fixation fastener |
| ***Product Code*** | HWC |
| ***Regulation Number & Classification Name*** | 21 CFR 888.3040 Screw, Fixation, Bone |
| ***Regulatory Class*** | II |
| ***Primary Predicate Device*** | K243195 Arthrex SS VAL and VAL KreuLock Compression Screw System |
| ***Additional Predicate Devices*** | K241592 Arthrex VAL and VAL KreuLock Compression Screw System K242554 Arthrex VAL and VAL KreuLock Compression Screw System K203294 Arthrex Pilon Fusion System K220937 Arthrex Mini Fragment System |
| ***Reference Devices*** | K201132 Arthrex Compression Screws |
| ***Purpose of Submission*** | This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System. |
| ***Device Description*** | The Arthrex VAL KreuLock™ Compression Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) or titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking (VAL) screws that are offered in standard and reinforced configurations. They are offered with a 2.0 mm, 2.7 mm, 3.0 mm or 3.5 mm diameter and range in lengths |
K260809: Page 1 of 7
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from 6 mm to 110 mm. The screws are sold single-use and sterile.
The Arthrex VAL Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) or titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking (VAL) screws that are offered in standard and reinforced configurations. 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 sterile.
The Arthrex Hybrid 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 (VAL) screws. They consist of existing screws cleared under K201132 and 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 length from 12 mm to 80 mm. The screws are sold single-use and sterile.
The Arthrex Hybrid Low Profile VAL Screws are fracture fixation devices comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They 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 Low Profile VAL Screws range in length from 10 mm to 80 mm. The screws are sold single-use and sterile.
The Arthrex Low Profile Screws are fracture fixation devices consisting of fully threaded, solid and non-locking screws. The Arthrex Low Profile Screws are offered with a 3.5 mm diameter and range in lengths
K260809: Page 2 of 7
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| | from 62 mm to 78 mm. The Arthrex Low Profile Screws are a line extension to and fall within the size range of existing screws cleared within K203294. The screws are manufactured from Titanium alloy, Ti-6AL-4V conforming to ASTM F136. The screws are sold single-use and sterile. The Arthrex Cortical Screws are fracture fixation devices consisting of fully threaded, self-tapping screws composed of titanium alloy, Ti-6AL-4V conforming to ASTM F136. The Arthrex Cortical Screws are offered with a 2.7 mm diameter and are 6-80 mm in length. The Arthrex Cortical Screws are sold single-use and sterile. |
| --- | --- |
| ***Indications for Use*** | 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 (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 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 |
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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 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 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,
K260809: Page 4 of 7
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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 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.
The Arthrex Low Profile 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 nonunions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates and Osteotomy Plates.
The Arthrex Mini Fragment System is indicated for fracture fixation, reconstruction, replantation, stabilization, reduction, fusions, osteotomies, mal-unions, and non-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12-21 years) patients. The system
K260809: Page 5 of 7
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| | is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. |
| --- | --- |
| ***Performance Data*** | The proposed Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System consists of sterile versions of screws that have already been cleared by the FDA under primary and additional predicate devices K241592, K242554, K243195 and K220937. Since the sterile and non-sterile versions share identical fit, form, and function, and sterilization does not affect the strength of the devices, the testing performed in the previously cleared 510(k)s are also applicable to the subject devices. |
| ***Technological Comparison*** | The Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System is substantially equivalent to the primary predicate device primary predicate device (K243195) and additional predicate devices (K241592, K242554, K203294 and K220937) in which the basic design features and fundamental scientific technology are equivalent. The Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System is manufactured from stainless steel and titanium, which is the same materials as the primary predicate device (K243195) and additional predicate devices (K241592, K242554, K203294 and K220937). The Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System consist of sterile versions of the non-sterile screws cleared within primary predicate device (K243195) and additional predicate devices (K241592, K242554, K203294 and K220937). The Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System is packaged in a different packaging configuration than the non-sterile screws cleared within the primary predicate device (K243195) and additional predicate devices (K241592, K242554, K203294 and K220937). |
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{11}
| | The Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System is offered with a different shelf life than the shelf life of the non-sterile screws cleared within the primary predicate device (K243195) and additional predicate devices (K241592, K242554, K203294 and K220937). The Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System was evaluated for MR Conditional safety. The primary predicate device (K243195) and additional predicate devices (K241592, K242554, K203294 and K220937) were also evaluated for MR Conditional safety. |
| --- | --- |
| **Conclusion** | Based on the intended use, fundamental scientific technology, and the data provided in this Traditional 510(k), Arthrex has determined that the proposed Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System is substantially equivalent to the primary predicate device Arthrex SS VAL and VAL KreuLock Compression Screw System (K243195) and additional predicate devices Arthrex VAL and VAL KreuLock Compression Screw System (K241592), Arthrex VAL and VAL KreuLock Compression Screw System (K242554), Arthrex Pilon Fusion System (K203294) and Arthrex Mini Fragment System (K220937). Any differences between the proposed and predicate devices are considered minor and do not raise different questions concerning safety and effectiveness. |
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
