The 2.4mm Non-Locking (NL) Hexalobe Screws are intended to be used in conjunction with The Acumed Wrist Fixation System, which consists of plates, screws, and instruments designed to aid in implantation. The intended use of the 2.4mm NL Hexalobe Screw is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna when used in conjunction with The Acumed Wrist Fixation System.

Device Description

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for "The Acumed Wrist Fixation System - 2.4mm Screws" (K252356) describe a medical device (bone screws), not an AI/software device. Therefore, the information requested regarding acceptance criteria and studies specifically for AI/software performance metrics (such as "sample size used for the test set," "data provenance," "number of experts," "MRMC comparative effectiveness study," "standalone performance," and "training set") is not applicable or cannot be extracted from this document.

The document discusses substantial equivalence based on non-clinical performance testing for a physical medical implant.

However, I can extract the acceptance criteria and the summary of the study results that demonstrate the device meets these criteria, as described in the provided text.

Acceptance Criteria and Study for The Acumed Wrist Fixation System - 2.4mm Screws (K252356)

The device, "The Acumed Wrist Fixation System - 2.4mm Screws," is a physical medical implant, not an AI/software device. Its acceptance criteria and performance evaluation are based on non-clinical engineering and materials testing, adhering to recognized consensus standards and FDA guidance documents for medical devices of this type.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Standard/Guidance Document	Acceptance Criteria (Implied by "passing results")	Reported Device Performance
Mechanical Performance	Torsional Strength	ASTM F543-23	Must meet specified torsional strength for metallic medical bone screws.	"Generated passing results."
	Driving Torque	ASTM F543-23	Must meet specified driving torque for metallic medical bone screws.	"Generated passing results."
	Axial Pullout Strength	ASTM F543-23	Must meet specified axial pullout strength (calculated).	"Generated passing results."
MR Compatibility	Magnetically Induced Force	ASTM F2052	Must demonstrate safe or acceptable magnetically induced force in MR environment.	"Evaluations were conducted, generated passing results."
	Magnetically Induced Torque	ASTM F2213	Must demonstrate safe or acceptable magnetically induced torque in MR environment.	"Evaluations were conducted, generated passing results."
	RF-Induced Heating	ASTM F2182	Must demonstrate safe or acceptable radio frequency induced heating near passive implants during MRI.	"Evaluations were conducted, generated passing results."
	Image Artifacts	ASTM F2119	Must demonstrate acceptable levels of MR image artifacts from passive implants.	"Evaluations were conducted, generated passing results."
General Equivalence	Safety & Performance	Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway (FDA Guidance, Nov 22, 2024)	The device must be deemed substantially equivalent to the predicate device in terms of safety and performance.	"The evaluation performed... have generated passing results, deeming the 2.4mm Non-Locking Hexalobe Screws substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (number of screws) used for each specific non-clinical test (e.g., torsional strength, driving torque, pullout calculations, or MR compatibility evaluations). These tests typically involve a predetermined number of test specimens according to the respective ASTM standards to ensure statistical validity.
Data Provenance: Not applicable in the context of clinical data for an AI device. The data provenance here refers to the source of the physical test specimens (manufactured according to specifications) and the laboratory where the tests were conducted (implied to be in-house or by a certified testing facility).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable as the document describes non-clinical engineering tests for a physical device, not an AI/software device requiring expert ground truth for image or data interpretation. Performance is assessed against engineering standards.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) refer to clinical expert consensus for ground truth establishment in studies involving human interpretation, which is not relevant to the non-clinical testing of this physical device. The "adjudication" in this context would be the interpretation and approval of test results against the specified ASTM standards by qualified engineers and regulatory specialists.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not applicable to a physical bone screw. The submission states, "Clinical Testing was not required to support substantial equivalence (Not Applicable)."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical bone screw and not an algorithm or software. Its performance is inherent to its physical properties and design, tested independently of human intervention during the test itself (though human engineers conduct the tests).

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is defined by the specific requirements and methodologies outlined in the referenced ASTM consensus standards (e.g., ASTM F543-23 for mechanical properties, ASTM F2052, F2213, F2182, F2119 for MR compatibility). These standards provide quantifiable thresholds and test procedures that determine if a device performs as expected for its intended use. In essence, the "ground truth" is compliance with these established engineering and material science specifications.

8. The Sample Size for the Training Set

This question is not applicable. The concept of a "training set" refers to data used to train an AI model. This device is a physical product and does not involve AI.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no AI training set for this physical device.

Summary

FDA 510(k) Clearance Letter - K252356

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 21, 2025

Acumed LLC
Marina Bull
Regulatory Affairs Specialist
5885 NE Cornelius Pass Rd
Hillsboro, Oregon 97124

Re: K252356
Trade/Device Name: The Acumed Wrist Fixation System - 2.4mm 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: July 29, 2025
Received: July 29, 2025

Dear Marina Bull:

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.

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K252356 - Marina Bull Page 2

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 (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 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-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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K252356 - Marina Bull Page 3

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, M.S.
Assistant Director
DHT6C: Division of Restorative, Repair and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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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. K251132

Please provide the device trade name(s).
The Acumed Wrist Fixation System - 2.4mm Screws

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510(k) #: K252356
Prepared on: 2025-07-29

Contact Details - 21 CFR 807.92(a)(1)

Applicant Name: Acumed LLC
Applicant Address: 5885 NE Cornelius Pass Rd Hillsboro OR 97124 United States
Applicant Contact Telephone: 970-846-6282
Applicant Contact: Ms. Marina Bull
Applicant Contact Email: marina.bull@acumed.net

Device Name - 21 CFR 807.92(a)(2)

Device Trade Name: The Acumed Wrist Fixation System - 2.4mm Screws
Common Name: Screw, Plate, Fixation, Bone
Classification Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulation Number: 888.3030, 888.3040
Product Code(s): HRS, HWC

Legally Marketed Predicate Devices - 21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K251132	The Acumed Wrist Fixation System	HRS, HWC

Device Description Summary - 21 CFR 807.92(a)(4)

Intended Use/Indications for Use - 21 CFR 807.92(a)(5)

Indications for Use Comparison - 21 CFR 807.92(a)(5)

The primary method of determining Substantial Equivalence is the standard Performance Based Pathway. The following Guidance Documents were used to determine Substantial Equivalence.

Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway issued on November 22, 2024.

The basis of substantial equivalence between the Subject Device and the Predicate Devices is their similarities in intended use, material,

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technology, operating principles, anatomical site for implantation, performance and design. The analysis between the Subject Devices and Predicate Devices supports substantial equivalence as the differences do not constitute a new intended use and do not raise additional questions of safety and effectiveness.

The proposed indications for use are: The 2.4mm Non-Locking (NL) Hexalobe Screws are intended to be used in conjunction with The Acumed Wrist Fixation System, which consists of plates, screws, and instruments designed to aid in implantation. The intended use of the 2.4mm NL Hexalobe Screw is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna when used in conjunction with The Acumed Wrist Fixation System.

Technological Comparison - 21 CFR 807.92(a)(6)

The Subject Device has the same technological characteristics as the Predicate Device except for difference in screw head design. The technological characteristics, operating principles, and anatomical site for implantation of the subject device is identical to that of the predicate device, which is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna when used in conjunction with The Acumed Wrist Fixation System, per ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws.

Non-Clinical and/or Clinical Tests Summary & Conclusions - 21 CFR 807.92(b)

The 2.4mm Non-Locking Hexalobe Screws were compared to the Predicate Device, The 2.4mm Non-Locking Hexalobe Screw cleared under K251132, As part of The Acumed Wrist Fixation System, per ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws.

Torsional Strength and Driving torque testing of the subject screws was conducted according to ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws.

Theoretical axial pullout strength calculation of the subject screws according to ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws.

Magnetically induced force, torque, radio frequency induced heating, and image artifact evaluations were conducted in accordance with ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment, ASTM 2182 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.

Clinical Testing was not required to support substantial equivalence (Not Applicable).

The 2.4mm Non-Locking Hexalobe Screws (Subject Device) have undergone testing in accordance with the FDA issued Guidance Document:

Orthopedic non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway issued on November 22, 2024.

The evaluation performed against the Safety and Performance based Pathway Guidance Document have generated passing results, deeming the 2.4mm Non-Locking Hexalobe Screws substantially equivalent to the Predicate Device, The 2.4mm Non-Locking Hexalobe Screws as Part of The Acumed Wrist Fixation System (K251132).

Regulation Number and Section

N/A