<?xml version="1.0"?>
<ownershipDocument>

    <schemaVersion>X0508</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2025-12-11</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

    <issuer>
        <issuerCik>0001699350</issuerCik>
        <issuerName>SHOULDER INNOVATIONS, INC.</issuerName>
        <issuerTradingSymbol>SI</issuerTradingSymbol>
    </issuer>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0002070664</rptOwnerCik>
            <rptOwnerName>Ball Robert Joseph</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerStreet1>C/O SHOULDER INNOVATIONS, INC.</rptOwnerStreet1>
            <rptOwnerStreet2>1535 STEELE AVENUE SW, SUITE B</rptOwnerStreet2>
            <rptOwnerCity>GRAND RAPIDS</rptOwnerCity>
            <rptOwnerState>MI</rptOwnerState>
            <rptOwnerZipCode>49507</rptOwnerZipCode>
            <rptOwnerStateDescription></rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>1</isDirector>
            <isOfficer>1</isOfficer>
            <isTenPercentOwner>0</isTenPercentOwner>
            <isOther>0</isOther>
            <officerTitle>CEO &amp; Executive Chairman</officerTitle>
        </reportingOwnerRelationship>
    </reportingOwner>

    <aff10b5One>0</aff10b5One>

    <nonDerivativeTable>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <transactionDate>
                <value>2025-12-11</value>
            </transactionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>P</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>3300</value>
                </transactionShares>
                <transactionPricePerShare>
                    <value>14.8285</value>
                    <footnoteId id="F1"/>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>114557</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>D</value>
                </directOrIndirectOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <transactionDate>
                <value>2025-12-12</value>
            </transactionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>P</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>3900</value>
                </transactionShares>
                <transactionPricePerShare>
                    <value>14.8911</value>
                    <footnoteId id="F2"/>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>118457</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>D</value>
                </directOrIndirectOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
    </nonDerivativeTable>

    <derivativeTable></derivativeTable>

    <footnotes>
        <footnote id="F1">The price reported in Column 4 is a weighted average purchase price. The shares of Common Stock were purchased in multiple transactions at prices ranging from $14.56 to $15.16, inclusive. The Reporting Person undertakes to provide upon request by the staff of the Securities &amp; Exchange Commission, the Issuer or any security holder of the Issuer, full information regarding the number of shares of Common Stock purchased at each separate price within the range set forth herein.</footnote>
        <footnote id="F2">The price reported in Column 4 is a weighted average purchase price. The shares of Common Stock were purchased in multiple transactions at prices ranging from $14.60 to $15.26, inclusive. The Reporting Person undertakes to provide upon request by the staff of the Securities &amp; Exchange Commission, the Issuer or any security holder of the Issuer, full information regarding the number of shares of Common Stock purchased at each separate price within the range set forth herein.</footnote>
    </footnotes>

    <remarks></remarks>

    <ownerSignature>
        <signatureName>/s/ Jeffrey Points, as Attorney-in-Fact</signatureName>
        <signatureDate>2025-12-15</signatureDate>
    </ownerSignature>
</ownershipDocument>
