The TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.

Device Description

The TITAN 3-D® Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the TITAN 3-D Wedge System, based on the provided text. Please note that the document is a 510(k) summary for a medical device (an implant for bone fixation), not an AI/software device. Therefore, many of the requested categories related to AI performance, such as expert ground truth, adjudication methods, and MRMC studies, are not applicable.

Device Name: TITAN 3-D® Wedge System

Device Type: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories (Implantable device)

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an implantable device, the acceptance criteria are not for diagnostic performance (like sensitivity/specificity) but rather for safety and mechanical performance. The document describes performance testing related to MR Safety and mechanical properties.

Acceptance Criterion (Type)	Specific Test/Standard	Reported Device Performance (Outcome)
MR Safety & Compatibility	ASTM F2119	Image Artifact (Pass)
	ASTM F2052	Magnetically Induced Displacement Force (Pass)
	ASTM F2213	Magnetically Induced Torque (Pass)
	ASTM F2182	Radiofrequency (RF) Induced Heating (Pass)
Mechanical Performance	Dynamic Compression	Verified change does not raise new questions of safety and effectiveness (Pass)
	Static Compression	Verified change does not raise new questions of safety and effectiveness (Pass)
	Static Compressive Shear	Verified change does not raise new questions of safety and effectiveness (Pass)

Note: "Pass" implies that the device met the specified requirements of the respective ASTM standards or verified that the changes did not negatively impact safety or effectiveness.

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

The document does not specify a "test set" in the context of patient data or images. Instead, the testing involves physical samples of the device for mechanical and MR safety testing.

Sample Size for Testing: Not explicitly stated as a number of devices, but implies testing was performed on representative samples for each test (e.g., multiple wedges for mechanical testing, a representative wedge for MR testing).
Data Provenance: Not applicable as this refers to physical device testing, not clinical data or images from specific countries.

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

Not applicable. This device is an implant, not a diagnostic AI/software tool. Ground truth for its performance is established through standardized laboratory testing (e.g., ASTM standards) conducted by qualified engineers and technicians, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. See explanation for #3. Laboratory test results are typically objective measurements against a standard, not subject to subjective adjudication.

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

No. This is an implantable medical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant for its evaluation.

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

Not applicable. This is an implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on established engineering principles, material science, and performance standards (e.g., ASTM standards for mechanical properties and MR compatibility). It's scientific measurement and verification against defined criteria, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or prognostic study.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/software product that requires a training set.

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

Not applicable. See explanation for #8.

Summary

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August 22, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Paragon 28 Inc Haylie Hertz Associate Manager of Regulatory Affairs 14445 Grasslands Drive Englewood, Colorado 80112

Re: K231496

Trade/Device Name: TITAN 3-D Wedge System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PLF Dated: May 23, 2023 Received: May 24, 2023

Dear Haylie Hertz:

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

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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 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,

Shumaya Ali -S

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

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Indications for Use

510(k) Number (if known)

K231496

Device Name TITAN 3-D® Wedge System

Indications for Use (Describe)

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)

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K231496 510(K) SUMMARY

510(k) Number:	K231496
Manufacturer:	Paragon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112
Contact:	Haylie HertzAssociate Manager of Regulatory AffairsParagon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112Phone: 303-720-0017hhertz@paragon28.com
Date Prepared:	August 22, 2023
Device Trade Name:	TITAN 3-D® Wedge System
Device Class:	Class II
Predicate Device:	TITAN 3-D® Wedge System (K162241)
Device Description:	The TITAN 3-D® Wedge System contains a series of titanium alloyimplants used for the correction of small bones in the foot. It isoffered in varying shapes and sizes to accommodate a variety ofsmall bone applications. The implants are sold sterile.
Classification andProduct Code:	21 CFR 888.3030; Single/multiple component metallic bonefixation appliances and accessories; PLF
Indications for Use:	The TITAN 3-D® Wedge System implants are indicated to be usedfor internal bone fixation for bone fractures, fusions, or osteotomiesin the foot and ankle. The TITAN 3-D® Wedge System implantsare intended for use with ancillary fixation. The TITAN 3-D®Wedge System implants are not indicated for use in the spine.
SubstantialEquivalence:	The intended use, principle of operation and fundamental scientifictechnology of the modified device are identical to the predicatedevice. The MR safety and compatibility performance wasassessed via testing in the MRI environment and labeling wasupdated per the FDA Guidance “Testing and Labeling MedicalDevices for Safety in the Magnetic Resonance (MR) Environment”issued May 20, 2021. The data demonstrate substantial equivalenceand the subject modifications do not raise new issues of safety oreffectiveness.The subject device has the addition of new contract suppliers andrepeated performance testing has indicated that the supplier changedoes not raise new issues of safety or effectiveness. There are no

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new chemicals or processes that the implant is exposed to when compared to the predicate therefore no new issues of safety and effectiveness are raised.

Performance MR Safety and Compatibility Testing has been completed and Testing: presented in the submission as recommended in the FDA Guidance "Testing and Labeling Medical Devices for Safetv in the Magnetic Resonance (MR) Environment" issued May 20, 2021, including FDA-recognized standards tests for the following potential hazards:

. Image Artifact per ASTM F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
. Magnetically Induced Displacement Force per ASTM F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Magnetically Induced Torque per ASTM F2213 Test ● Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
. Radiofrequency (RF) Induced Heating per ASTM F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging

Based on the results, the TITAN 3-D® Wedge System will be labeled as "MR Conditional" with MRI Safety Information in the instructions for use as described in ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Performance testing for dynamic compression, static compression, and static compressive shear verified the change does not raise new questions of safety and effectiveness.

Conclusion: The proposed device modifications do not raise new issues of safety or effectiveness and have been fully evaluated. The subject devices are substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 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.