(90 days)
The Arthrex 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, and wrist. 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 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, 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 Compression FT Screws (2.0-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.
The Arthrex Compression FT Screws (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws 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, femur and fibula.
The Arthrex KreuLock Compression Screws are a family of screws that are offered in a diameter range of 2.4 to 4.5 mm, length range of 10 to 80 mm, in a fully threaded design, solid, and locking design. The Arthrex KreuLock Compression Screws are intended to be used with plates in the same applications as existing Arthrex Low Profile Screws. Those plates remain unchanged. The Arthrex KreuLock Compression Screws are manufactured from either Titanium or Stainless Steel materials and are available in straight or variable angle configurations. The screws are sold sterile or non-sterile and single-use.
The Arthrex Compression FT Screws are a family of screws that are offered in a diameter range of 2.8 to 7.0 mm, length range of 8 to 140 mm, in a fully threaded and cannulated design. The Arthrex Compression FT Screws are manufactured from Titanium. The screws are sold sterile or non-sterile and single-use.
This document describes the premarket notification (510(k)) for Arthrex Compression Screws (K201132). The primary focus of the performance data section is mechanical testing to demonstrate substantial equivalence to predicate devices, rather than a study involving a diagnostic AI device or human-in-the-loop performance. Therefore, most of the requested information (related to AI acceptance criteria, expert ground truth, MRMC studies, etc.) is not applicable to this submission.
However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the study performed:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Arthrex Compression Screws are based on demonstrating "statistical equivalence" to predicate devices in mechanical performance. The reported performance is that the device meets these criteria, showing substantial equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Statistical equivalence to predicate devices for: | |
| - Push-out strength | The submitted mechanical testing data demonstrates that the push-out strength of the proposed devices are substantially equivalent to that of the predicate devices. |
| - Insertion torque/failure torque | The submitted mechanical testing data demonstrates that the torque of the proposed devices are substantially equivalent to that of the predicate devices. |
| - Compression strength | The submitted mechanical testing data demonstrates that the compression strength of the proposed devices are substantially equivalent to that of the predicate devices. |
| MR Compatibility: Compliance with specified ASTM standards for: | Conducted per ASTM F2052-15 (displacement force), ASTM F2213-17 (torque), ASTM F2119-13 (image artifact), and ASTM F2182-11a (RF Heating). (The text states these tests were "conducted," implying they met the standards for MR compatibility without providing specific numerical results, usually indicating successful completion as per regulatory expectations.) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the mechanical testing (e.g., number of screws tested for each mechanical property). Mechanical testing typically involves a set number of samples per configuration (e.g., diameter, length, material) to achieve statistical significance.
The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective" because this is mechanical testing, not a clinical study involving human patient data. It's an engineering test performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of mechanical testing, is established by scientific principles and validated testing methodologies, not by expert human interpretation. The "truth" is the measured mechanical property.
4. Adjudication method for the test set
Not applicable. There is no human interpretation or subjective assessment that requires adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This is a mechanical device, not an AI or imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (screws), not an algorithm.
7. The type of ground truth used
The ground truth for this study is derived from:
- Physical measurements: The actual measurements of push-out force, insertion/failure torque, and compression strength.
- Standardized testing methods: Adherence to established mechanical testing standards (e.g., for strength, torque) and specific ASTM standards for MR compatibility.
- Statistical comparison: The performance is compared statistically to the known performance of predicate devices.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of mechanical device submission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for mechanical testing.
{0}------------------------------------------------
July 27, 2020
Image /page/0/Picture/1 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. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Samantha Passman Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K201132
Trade/Device Name: Arthrex Compression Screws 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: April 22, 2020 Received: April 28, 2020
Dear Samantha Passman:
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 (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 located 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.
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 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Shumaya Ali, MPH 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K201132
Device Name Arthrex Compression Screws
Indications for Use (Describe)
The Arthrex 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile Plate. Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.
The Arthrex 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, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment 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."
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K201132
Device Name Arthrex Compression Screws
Indications for Use (Describe)
The Arthrex Compression FT Screws (2.0-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.
The Arthrex Compression FT Screws (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws 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, femur and fibula.
| 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 | July 27, 2020 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Samantha PassmanRegulatory Affairs Associate1-239-643-5553, ext. 71595Samantha.passman@arthrex.com |
| Name of Device | Arthrex Compression Screws |
| Common Name | Screw, fixation, bone |
| Product Code | HRS, HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances andaccessories (Primary)21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K103705: Arthrex Low Profile Screws (Primary)K111253: Arthrex Distal Extremity Plate SystemK131474: Arthrex Distal Radius Plate SystemK141735: Arthrex Ankle Fusion Plating SystemK151732: Arthrex Fracture PlatesK170547: Arthrex Mesh Plates |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex KreuLock Compression Screws as a line extension to the Arthrex LowProfile Screw family of products. This submission is also seeking to obtain LowProfile Screw indications for the Arthrex Compression FT Screws cleared underK132217, K170382, and K182361. |
| Device Description | The Arthrex KreuLock Compression Screws are a family of screws that are offeredin a diameter range of 2.4 to 4.5 mm, length range of 10 to 80 mm, in a fullythreaded design, solid, and locking design. The Arthrex KreuLock CompressionScrews are intended to be used with plates in the same applications as existingArthrex Low Profile Screws. Those plates remain unchanged. The ArthrexKreuLock Compression Screws are manufactured from either Titanium orStainless Steel materials and are available in straight or variable angleconfigurations. The screws are sold sterile or non-sterile and single-use.The Arthrex Compression FT Screws are a family of screws that are offered in adiameter range of 2.8 to 7.0 mm, length range of 8 to 140 mm, in a fully threadedand cannulated design. The Arthrex Compression FT Screws are manufacturedfrom Titanium. The screws are sold sterile or non-sterile and single-use. |
| Indications for Use | The Arthrex KreuLock Compression Screws (2.0-3.0 mm solid) are intended to beused in a plate-screw system for internal bone fixation for bone fractures,fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. Whenused 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 DistalRadius Plates.The Arthrex KreuLock Compression Screws (3.5 mm and larger, solid) areintended to be used in a plate-screw system for internal bone fixation for bonefractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist,clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur andfibula. 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 AnkleFusion Plates. | |
| The Arthrex Compression FT Screws (2.0-3.0 mm cannulated) are intended to beused as stand-alone bone screws for internal bone fixation for bone fractures,fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. | |
| The Arthrex Compression FT Screws (3.5 mm and larger, cannulated) areintended to be used as stand-alone bone screws for internal bone fixation forbone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand,wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femurand fibula. | |
| Performance Data | Push-out, insertion torque/failure torque, and compression testing wereconducted to demonstrate that the proposed compression screws performstatistically equivalent to the predicate. MR compatibility testing was alsoconducted per ASTM F2052-15 (displacement force), ASTM F2213-17 (torque),ASTM F2119-13 (image artifact), and ASTM F2182-11a (RF Heating). |
| Conclusion | The Arthrex Compression Screws are substantially equivalent to the predicatedevices in which the basic design features and intended uses are the same. Anydifferences between the proposed devices and the predicate devices areconsidered minor and do not raise different questions concerning safety oreffectiveness.The submitted mechanical testing data demonstrates that the push-out, torque,and compression strength of the proposed devices are substantially equivalent tothat of the predicate devices for the desired indications. |
| Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed devices aresubstantially equivalent to the currently marketed predicate device. |
{5}------------------------------------------------
§ 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.