(101 days)
K082516 Smith & Nephew PERI-LOC Hexalobular Bone Screws
No
The device description and intended use are for mechanical bone screws and associated plates, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical and MRI compatibility tests.
Yes
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," which directly addresses and treats medical conditions.
No
Explanation: The device is described as a "fracture fixation device" and its intended use is for "internal bone fixation for bone fractures, fusions, osteotomies and non-unions." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is comprised of stainless steel screws, which are hardware components, 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 describes the device as being used for internal bone fixation during surgical procedures (fractures, fusions, osteotomies, non-unions). This is a therapeutic and structural function within the body.
- Device Description: The device is described as "fracture fixation devices comprised of stainless steel... self-tapping, solid, fully threaded, variable angle locking (VAL) screws." This is a physical implant used to stabilize bone.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The Arthrex VAL KreuLock™ and VAL Screws do not perform any such testing.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or functions of an IVD.
Therefore, the Arthrex VAL KreuLock™ and VAL Screws are medical devices used for surgical bone fixation, not in vitro diagnostics.
N/A
Intended Use / 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 (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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
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.
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 (Part 21 CFR 801 Subpart D)
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, compression testing, torque testing, axial pull-out analysis, torsional strength testing, and driving torque testing conducted in accordance with ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws on the proposed Arthrex SS 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 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): 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.
K201132 Arthrex Compression Screws, K103705 Arthrex Low Profile Screws
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.
K082516 Smith & Nephew PERI-LOC Hexalobular Bone Screws
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
2
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)
Device Name
Arthrex SS VAL and VAL KreuLock™ Compression Screw System
Indications for Use (Describe)
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, 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.
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 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 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 (2.7
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) 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. |
| Performance Data | Arthrex conducted pull-out testing, compression
testing, torque testing, axial pull-out analysis, torsional
strength testing, and driving torque testing conducted
in accordance with ASTM F543 Standard Specification
and Test Methods for Metallic Medical Bone Screws on
the proposed Arthrex SS 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 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 SS 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 SS VAL and VAL KreuLock™ Compression
Screw System is manufactured from stainless steel,
which is the same material as the primary predicate
cleared under K201132. |
| | The Arthrex SS VAL and VAL KreuLock™ Compression
Screw System devices have the same sterility, non-
sterile, as the primary predicate cleared under K201132. |
| | The Arthrex SS VAL and VAL KreuLock™ Compression
Screw System devices have the same packaging as the
primary predicate cleared under K201132. |
| | The Arthrex SS VAL and VAL KreuLock™ Compression
Screw System devices have the same shelf-life as the
primary predicate cleared under K201132. |
| | The Arthrex SS VAL and VAL KreuLock™ Compression
Screw System devices have the same fundamental
scientific technology as the primary predicate cleared
under K201132. |
| | The Arthrex SS 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 SS VAL and VAL KreuLock™ Compression
Screw System devices have an indications for use that
differs from the primary predicate cleared under
K201132. |
| | The Arthrex SS VAL and VAL KreuLock™ Compression
Screw System is offered in lengths outside of the
primary predicate range cleared under K201132. |
| | The Arthrex SS VAL and VAL KreuLock™ Compression
Screw System is substantially equivalent to the predicate
devices cleared under K201132. Any differences between
the Arthrex SS 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 SS 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. |
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