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

    <schemaVersion>X0609</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2026-10-05</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

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

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001474322</rptOwnerCik>
            <rptOwnerName>Tansey Casey M</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerNonUSAddressFlag>false</rptOwnerNonUSAddressFlag>
            <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>0</isOfficer>
            <isTenPercentOwner>1</isTenPercentOwner>
            <isOther>0</isOther>
        </reportingOwnerRelationship>
    </reportingOwner>

    <aff10b5One>0</aff10b5One>

    <nonDerivativeTable>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <transactionDate>
                <value>2026-10-05</value>
            </transactionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>A</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>733</value>
                    <footnoteId id="F1"/>
                </transactionShares>
                <transactionPricePerShare>
                    <value>19.60</value>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>53445</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>D</value>
                </directOrIndirectOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
        <nonDerivativeHolding>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>1686403</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>Held by U.S. Venture Partners XII, L.P.</value>
                    <footnoteId id="F2"/>
                    <footnoteId id="F3"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeHolding>
        <nonDerivativeHolding>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>85586</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>Held by U.S. Venture Partners XII-A, L.P.</value>
                    <footnoteId id="F2"/>
                    <footnoteId id="F3"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeHolding>
        <nonDerivativeHolding>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>921130</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>Held by U.S. Venture Partners Select Fund I, L.P.</value>
                    <footnoteId id="F2"/>
                    <footnoteId id="F3"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeHolding>
    </nonDerivativeTable>

    <derivativeTable></derivativeTable>

    <footnotes>
        <footnote id="F1">Represents an award of restricted stock units (&quot;RSUs&quot;) received in lieu of cash retainer fees, which were fully vested as of the grant date.  Each RSU represents a contingent right to receive one share of the Issuer's Common Stock and has no expiration date. The Reporting Person voluntarily elected to defer receipt of the Common Stock issuable upon settlement of the RSUs until the Reporting Person's departure from the Board of Directors.</footnote>
        <footnote id="F2">Presidio Management Group XII, L.L.C. (&quot;PMG XII&quot;) is the general partner of U.S. Venture Partners XII, L.P. (&quot;USVP XII&quot;) and U.S. Venture Partners XII-A, L.P. (&quot;USVP XII-A&quot;) and has sole voting and dispositive power with respect to the shares held by USVP XII and USVP XII-A. Steven M. Krausz, Richard W. Lewis, Jonathan D. Root and Dafina Toncheva are the managing members of PMG XII, and share voting and dispositive power with respect to the shares held by USVP XII and USVP XII-A. Casey M. Tansey is the managing partner of PMG XII and may be deemed to share voting and dispositive power over the reported securities held by USVP XII and USVP XII-A. Presidio Management Group Select Fund I, L.L.C. (&quot;PMG Select&quot;) is the general partner of U.S. Venture Partners Select Fund I, L.P. (&quot;USVP SFI&quot;), and U.S. Venture Partners Select Fund I-A, L.P. (&quot;USVP SFI-A&quot;) and has sole voting and dispositive power with respect to the shares held by USVP SFI on its own behalf and as nominee for USVP SFI-A.</footnote>
        <footnote id="F3">Richard W. Lewis, Jonathan D. Root and Dafina Toncheva are the managing members of PMG Select and share voting and dispositive power with respect to the shares held by USVP SFI on its own behalf and as nominee for USVP SFI-A. Casey M. Tansey, a member of the Issuer's board of directors, is the managing partner of PMG Select and may be deemed to share voting and dispositive power with respect to the shares held by USVP SFI on its own behalf and as nominee for USVP SFI-A. Each of the managing members and managing partner of PMG XII and PMG Select disclaims beneficial ownership of such holdings, except to the extent of their pecuniary interest in the shares.</footnote>
    </footnotes>

    <remarks></remarks>

    <ownerSignature>
        <signatureName>/s/ Jeffrey Points, as Attorney-in-Fact</signatureName>
        <signatureDate>2026-10-06</signatureDate>
    </ownerSignature>
</ownershipDocument>
