UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 30, 2014

Orthofix International N.V.

(Exact name of Registrant as specified in its charter)

Registrant’s telephone number, including area code: 011-59-99-465-8525

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

On September 30, 2014, Orthofix International N.V. (the “Company”), Orthofix Holdings, Inc. (“Holdings”) and certain wholly owned subsidiaries of Holdings (together with the Company and Holdings, the “Credit Parties”), and certain required lender parties thereto, entered into a Limited Waiver (the “Limited Waiver”) pursuant to the Credit Agreement, dated as of August 30, 2010, as amended, among the Credit Parties and the Lenders (the “Credit Agreement”). The Limited Waiver was entered into in connection with the previously disclosed delayed filing of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2014 (the “2014 Second Quarter Form 10-Q”), as well as the previously disclosed anticipated financial restatement.

Under the Limited Waiver, the lenders under the Credit Agreement (the “Lenders”) have collectively waived requirements under the Credit Agreement that the Credit Parties deliver quarterly financial statements of the Company and its subsidiaries with respect to each of the fiscal quarters ending on June 30, 2014 and September 30, 2014, and related financial covenant certificates, until the earlier of (i) January 15, 2015 or (ii) the date that is one day after such financial statements, in each case, are publicly filed or released. In addition, the Limited Waiver provides that the Company’s restatement of financial statements shall not constitute a default or event of default provided that within one business day after the public release or filing of such restated financial statements, the Company delivers corrected financial statements and compliance certificates with respect to such restated periods and immediately pays any additional interest and other fees that would have been owed had applicable interest and fees originally been calculated based on the restated financial statements. The Company does not expect the restatement to trigger any such additional interest or fees with respect to such prior periods.

The foregoing description does not constitute a complete summary of the terms of the Limited Waiver and is qualified in its entirety by reference to the full text of the Limited Waiver, which is filed as Exhibit 2.1 to this Form 8-K and incorporated herein by reference.

On October 3, 2014, the Company, through its subsidiary Orthofix Inc., entered into Amendment No. 1 to Employment Agreement with Doug Rice, the Company’s Interim Chief Financial Officer (the “Amendment”). The Amendment amends the employment agreement that was entered into with Mr. Rice on September 4, 2014, which was described in and filed with the Company’s Current Report on Form 8-K dated September 8, 2014.

The Amendment memorializes that Mr. Rice has been appointed to the position of Interim Chief Financial Officer as of September 27, 2014. The Amendment provides that during his time serving as Interim Chief Financial Officer, Mr. Rice’s annual base salary shall be increased to $325,000, and he shall be provided with an additional bonus opportunity as set forth in the Amendment. The Amendment also provides that Mr. Rice will receive a grant of 6,000 shares of restricted common stock in connection with his appointment as Interim Chief Financial Officer.

The foregoing description of the Amendment is a summary of material terms thereof, and is qualified in its entirety by the text of the Amendment, a copy of which is filed herewith as Exhibit 10.1 and incorporated herein by reference.

(d) Exhibits

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: October 6, 2014

EXHIBIT INDEX

Exhibit 2.1

LIMITED WAIVER

Limited Waiver, dated as of September 30, 2014 (this “Limited Waiver”), to the Credit Agreement, dated as of August 30, 2010, as amended by the First Amendment dated as of May 4, 2011 (as further amended, modified, restated and supplemented through the date hereof, and as waived pursuant to, and subject to the provisions of, that certain Consent, dated as of April 23, 2012, that certain Limited Waiver, dated as of June 27, 2013, that certain Limited Waiver, dated as of August 14, 2013 and that certain Limited Waiver, dated as of August 14, 2014, the “Credit Agreement”), among Orthofix Holdings, Inc., a Delaware corporation (the “Borrower”), Orthofix International N.V., a Curacao company (the “Company”), those Domestic Subsidiaries of the Company identified as a “Guarantor” on the signature pages thereto and such other Domestic Subsidiaries of the Company as may from time to time become a party thereto, the several banks and other financial institutions parties thereto (collectively, the “Lenders”; and individually, a “Lender”), and JPMorgan Chase Bank, N.A., as administrative agent (in such capacity, the “Administrative Agent”).

W I T N E S S E T H:

WHEREAS, the Borrower, the Company, the Guarantors, the Lenders and the Administrative Agent are parties to the Credit Agreement;

WHEREAS, the Borrower has requested that the Required Lenders waive compliance with Section 5.1(c) of the Credit Agreement and Section 5.2(b) of the Credit Agreement requiring the delivery of quarterly financial statements for each of the fiscal quarters ending on June 30, 2014 and September 30, 2014 and related certificates of a Responsible Officer only until the earlier of (a) January 15, 2015 and (b) one Business Day after such financial statements are publicly released or filed (the “Requested Waiver”);

WHEREAS, until such financial statements and certificates are received by the Administrative Agent, the Borrower is willing to agree to certain additional limitations on certain of its actions;

WHEREAS, the Borrower has requested certain other accommodations set forth herein (including with respect to any potential need by the Company to file restated financial statements for any prior annual or quarterly period ending on or prior to March 31, 2014 (any such period, a “Restatement Period”);

WHEREAS, the Required Lenders are willing to agree to the Requested Waiver and other accommodations subject to the provisions and additional limitations of this Limited Waiver;

NOW, THEREFORE, the parties hereto hereby agree as follows:

SECTION 1. Defined Terms. Capitalized terms used but not defined herein shall have the meanings assigned to such terms in the Credit Agreement.

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SECTION 2. Limited Waivers.

(a) Subject to the terms of this Limited Waiver, including, without limitation, compliance by the Borrower with each of the terms of Section 3 below, the Required Lenders hereby (i) agree to the Requested Waiver and waive compliance by the Credit Parties with Section 5.1(c) of the Credit Agreement and 5.2(b) of the Credit Agreement for the fiscal quarters ending on June 30, 2014 and September 30, 2014 only. This Limited Waiver (a) is limited and does not relate to (i) any other covenant or provision of the Credit Agreement or any other Credit Document, and (ii) any period other than the fiscal quarters ending on June 30, 2014 and September 30, 2014, and (b) shall automatically terminate and be of no further force or effect if (i) there exists any other Default or Event of Default or (ii) the Borrower fails to comply with any of the terms of Section 3 below.

(b) Subject to the terms of this Limited Waiver, including, without limitation, compliance by the Borrower with each of the terms of Section 3 below, the Required Lenders hereby agree that any restatement by the Company of its financial statements for any Restatement Period shall not constitute a Default or an Event of Default under Article VII or any other provision of the Credit Agreement provided that within one Business Day after the public release or filing of such restated financial statements Borrower (x) delivers to the Administrative Agent a corrected compliance certificate for each such period, (y) re-determines the Applicable Percentage for the Revolving Loans and Term Loans for such periods based upon the corrected compliance certificate, and (z) immediately pays to the Administrative Agent for the ratable benefit of the Lenders in immediately available Dollars, the aggregate amount of any additional interest and other fees that would have accrued if each of the financial statements delivered that included any portion of such Restatement Period had been correct when initially delivered. This Limited Waiver (a) is limited and does not relate to (i) any other covenant or provision of the Credit Agreement or any other Credit Document, and (ii) any period other than a Restatement Period, and (b) shall automatically terminate and be of no further force or effect if (i) there exists any other Default or Event of Default or (ii) the Borrower fails to comply with any of the terms of Section 3 below.

SECTION 3. Limited and Conditional Waiver; Requirements. Borrower agrees that the foregoing waiver is subject to, and conditioned upon, the Borrower’s compliance with the each of following:

(a) Limitation on Borrowings. Borrower agrees that during the Non-Compliance Period and notwithstanding any provision in the Credit Agreement to the contrary, the Borrower will not be entitled to borrow more than $50,000,000 in the aggregate outstanding amount at any time for all Loans and LOC Obligations (and Credit Parties hereby agree that during the Non-Compliance Period the Lenders have no obligation to make available Loans or Letters of Credit to the Borrower in excess of $50,000,000 in the aggregate outstanding for all Loans and LOC Obligations at any time). “Non-Compliance Period” means the period commencing on August 14, 2014 and ending on the first Business Day after the date that the financial statements for each of the fiscal quarters ending June 30, 2014 and September 30, 2014 have been received by the Administrative Agent, in each case together with the related certificate required by Section 5.2(b) of the Credit Agreement with respect to such fiscal quarter, in full compliance with each of Sections 5.1(c) of the Credit Agreement and 5.2(b) of the Credit Agreement (other than the delay in delivery) and demonstrating that the Borrower was in compliance with the terms of the Credit Agreement as of the end of each such fiscal quarter.

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(b) Delivery of Financial Statements and Responsible Officer Certificate. The Borrower shall

(i) deliver the financial statements described by Section 5.1(c) of the Credit Agreement and the certificates required by Section 5.2(b) of the Credit Agreement for each of the fiscal quarters ended June 30, 2014 and September 30, 2014 on or prior to the earlier to occur of (A) January 15, 2015 and (B) one Business Day after any public release or filing of financial statements for such fiscal quarter (with respect to each such fiscal quarter, the “Required Compliance Date”),

(ii) be in full compliance with Section 5.1(c) of the Credit Agreement and Section 5.2(b) of the Credit Agreement (except for the delay in delivery as permitted hereby) and all other terms of the Credit Agreement and the other Credit Documents by the Required Compliance Date for each such fiscal quarter, and

(iii) upon delivery of the financial statements and related certificates as set forth above, in each case demonstrate that the Borrower was in compliance with the terms of the Credit Agreement as of the applicable fiscal quarter end (i.e., June 30, 2014 and September 30, 2014).

For the avoidance of doubt (1) and notwithstanding anything in the Credit Agreement to the contrary, on each Required Compliance Date the Borrower must show that it was at all times during the term of this Agreement in compliance with the terms of the Credit Agreement (except for the delay in delivery as permitted hereby), including without limitation, the financial covenants set forth in Section 5.9 of the Credit Agreement as of the respective quarter end of June 30, 2014 or September 30, 2014, as applicable, (2) the Borrower agrees that on and after the occurrence of the Required Compliance Date for each of the fiscal quarters ended June 30, 2014 and September 30, 2014, the Borrower must be in full compliance with all terms of the Credit Agreement, including, without limitation, Section 5.1(c) of the Credit Agreement and Section 5.2(b) of the Credit Agreement, and (3) notwithstanding any provision of the Credit Agreement or any other Credit Document to the contrary, the failure of the Borrower to deliver the financial statements for the fiscal quarters ended June 30, 2014 and September 30, 2014 (in full compliance with Section 5.1(c) of the Credit Agreement except for the delay) and the related certificate of Responsible Officer under Section 5.2(b) of the Credit Agreement (in full compliance with Section 5.2(b) of the Credit Agreement except for the delay) on or prior to its respective Required Compliance Date will constitute an immediate Event of Default under the Credit Agreement (without any grace period, cure period or notice of any kind).

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(c) Additional Limitations on Certain Actions. Borrower and each other Credit Party agrees that during the Non-Compliance Period no Credit Party will, nor will any Credit Party permit any Subsidiary to, notwithstanding the provisions of:

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SECTION 4. Pricing During the Non-Compliance Period. Notwithstanding the provisions of the definition of “Applicable Percentage” in the Credit Agreement and subject to the following sentence, during the Non-Compliance Period, Revolving Loans, Commitment Fees and Letter of Credit Fees will accrue at Revolving Pricing Level IV as set forth in the Revolving Pricing Grid in the definition of “Applicable Percentage” in the Credit Agreement; provided that, notwithstanding the foregoing, if there at any time exists an Event of Default, Revolving Loans, Commitment Fees and Letter of Credit Fees will accrue at Revolving Pricing Level I in the Revolving Pricing Grid set forth in the definition of “Applicable Percentage” in the Credit Agreement, and Section 2.9 of the Credit Agreement will be applicable at the discretion of the Required Lenders as set forth therein. In the event that upon delivery of the Borrower’s financial statements and compliance certificate for the fiscal quarter ended June 30, 2014 or the fiscal quarter ended September 30, 2014, or both, such compliance certificate or such compliance certificates demonstrate that the Leverage Ratio would have prescribed a different Revolving Pricing Level under the Revolving Pricing Grid in the definition of “Applicable Percentage in the Credit Agreement, the Borrower shall immediately pay to the Administrative Agent for the ratable benefit of the Lenders in immediately available Dollars, the aggregate amount of any additional interest and other fees that would have accrued had the correct Revolving Pricing Level been in effect commencing on the applicable Interest Determination Dates.

SECTION 5. Effectiveness of Limited Waiver. This Limited Waiver shall become effective as of the date (the “Limited Waiver Effective Date”) on which the Administrative Agent receives counterparts to this Limited Waiver duly executed by a duly authorized officer of the Company, the Borrower and the Required Lenders.

SECTION 6. Expenses. The Borrower agrees to pay or reimburse the Administrative Agent for all of its reasonable out-of-pocket costs and expenses incurred in connection with this Limited Waiver, any other documents prepared in connection herewith and the transaction contemplated hereby, including, without limitation, the reasonable fees and disbursements of counsel to the Administrative Agent.

SECTION 7. Representations and Warranties. After giving effect to this Limited Waiver, the Borrower and the Company hereby confirm that, other than with respect to the matters described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 under the headings “Matters Related to the Audit Committee’s Review and the Restatement of Certain of our Consolidated Financial Statements” and “Review of Potential

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Improper Payments Involving Brazil Subsidiary” of Part I, Item 3, Legal Proceedings, in each case as such matters may relate to the representations in Section 3.3(iv) and Section 3.36 of the Credit Agreement, (a) the representations and warranties set forth in the Credit Agreement and in the Credit Documents are true and correct as if made on and as of the Limited Waiver Effective Date (other than any such representations or warranties that, by their terms, refer solely to an earlier date, in which case, as of such earlier date) and (b) before and after giving effect to this Limited Waiver, no Default or Event of Default shall have occurred and be continuing.

SECTION 8. Conditions of Effectiveness. This Limited Waiver shall be effective when the following conditions are each satisfied:

(a) the Administrative Agent shall have received counterparts of this Limited Waiver executed by the Required Lenders;

(b) the Administrative Agent shall have received counterparts of this Limited Waiver executed by the Borrower, the Company and acknowledged by each Guarantor;

(c) the Administrative Agent shall have received, on behalf of each Lender that timely executes this Limited Waiver and delivers it to the Administrative Agent (including JPMorgan Chase Bank, N.A., as a Lender), a waiver fee in an amount of $10,000 on such date; and

(d) the Administrative Agent shall have received in form and substance satisfactory to the Administrative Agent, such other documents, certificates and instruments as the Required Lenders shall require.

SECTION 9. Guarantors’ Acknowledgment. By signing below, each Guarantor (i) acknowledges, consents and agrees to the execution, delivery and performance by the Borrower and the Company of this Limited Waiver, (ii) acknowledges and agrees that its obligations in respect of its Guaranty are not released, diminished, waived, modified, impaired or affected in any manner by this Limited Waiver, or any of the provisions contemplated herein, (iii) confirms its obligations under its Guaranty and (iv) acknowledges and agrees that it has no claim or offsets against, or defenses or counterclaims to, its Guaranty.

SECTION 10. Reference to the Credit Agreement.

(a) Upon and during the effectiveness of this Limited Waiver, each reference in the Credit Agreement to “this Agreement”, “hereunder”, or words of like import shall mean and be a reference to the Credit Agreement, as affected by this Limited Waiver.

(b) Except as expressly set forth herein, this Limited Waiver shall not by implication or otherwise limit, impair, constitute a waiver of, or otherwise affect the rights or remedies of the Administrative Agent or the Lenders under the Credit Agreement or any of the other Credit Documents, and shall not alter, modify, amend, or in any way affect the terms, conditions, obligations, covenants, or agreements contained in the Credit Agreement or the other Credit Documents, all of which are hereby ratified and affirmed in all respects and shall continue in full force and effect.

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SECTION 11. GOVERNING LAW; WAIVERS OF JURY TRIAL. THIS LIMITED WAIVER AND THE RIGHTS AND OBLIGATIONS OF THE PARTIES HERETO SHALL BE GOVERNED BY, AND CONSTRUED AND INTERPRETED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK. EACH PARTY HERETO HEREBY AGREES SECTION 9.17 OF THE CREDIT AGREEMENT SHALL BE APPLICABLE TO THIS LIMITED WAIVER AS THOUGH SET FORTH HEREIN, MUTATIS MUTANDIS.

SECTION 12. Amendments; Execution in Counterparts.

(a) This Limited Waiver shall not constitute an amendment of any other provision of the Credit Agreement not referred to herein and shall not be construed as a waiver or consent to any further or future action on the part of the Company, the Borrower or any other Credit Party that would require a waiver or consent of the Lenders or the Administrative Agent. Except as expressly amended hereby, the provisions of the Credit Agreement are and shall remain in full force and effect.

(b) This Limited Waiver may be executed in any number of counterparts and by different parties hereto in separate counterparts, each of which when so executed and delivered shall be deemed to be an original and all of which when taken together shall constitute but one and the same instrument. For purposes of this Limited Waiver, a counterpart hereof (or signature page thereto) signed and transmitted by any Person party hereto to the Administrative Agent (or its counsel) by facsimile machine, telecopier or electronic mail is to be treated as an original. The signature of such Person thereon, for purposes hereof, is to be considered as an original signature, and the counterpart (or signature page thereto) so transmitted is to be considered to have the same binding effect as an original signature on an original document.

SECTION 13. Headings. Section headings in this Limited Waiver are included herein for convenience of reference only and shall not constitute a part of this Limited Waiver for any other purpose.

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IN WITNESS WHEREOF, the parties hereto have caused this Limited Waiver to be duly executed and delivered by their respective proper and duly authorized officers as of the day and year first above written.

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GUARANTORS:

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GUARANTORS:

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ADMINISTRATIVE AGENT:

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LENDER:

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Exhibit 10.1

AMENDMENT #1 TO

EMPLOYMENT AGREEMENT

This AMENDMENT #1 TO EMPLOYMENT AGREEMENT (this “Amendment”) is dated as of October 3, 2014, between Orthofix Inc., a Minnesota corporation (the “Company”), and Doug Rice (the “Executive”).

WHEREAS, the Executive and the Company have previously entered into an Employment Agreement as of September 4, 2014 (the “Agreement”); and

WHEREAS, the parties desire to enter into this Amendment to amend and revise the Agreement as set forth herein to, among other things, reflect the terms of an arrangement by which Executive will serve temporarily as the Company’s Interim Chief Financial Officer;

NOW, THEREFORE, in consideration of the foregoing, the mutual covenants and agreements of the parties contained herein and other good and valuable consideration, the receipt of which is hereby acknowledged, the parties hereto agree as follows:

1. Amendments.

“In addition to the foregoing, from September 27, 2014 until such time as the Company appoints a permanent, full-time Chief Financial Officer, Executive shall serve as the Company’s Interim Chief Financial Officer (the “Interim CFO Period). For the avoidance of doubt, in the event that Executive is not appointed as the Company’s permanent, full-time Chief Financial Officer, he shall continue serving as the Company’s Chief Accounting Officer, and notwithstanding anything in this Agreement to the contrary, the cessation of his term, duties and responsibilities as Interim Chief Financial Officer shall not constitute or form the basis of any “Good Reason” hereunder.”

“Notwithstanding the foregoing, during the Interim CFO Period, as well as any subsequent period in the event that Executive is appointed as the Company’s permanent, full-time Chief Financial Officer, Executive shall be paid an annual base salary of no less than $325,000. If Executive is not appointed as the Company’s permanent, full-time Chief Financial Officer, then his annual base salary as Chief Accounting Officer following the Interim CFO Period shall be no less than $275,000.”

“In addition to Executive’s regular incentive plan bonus (including Executive’s 35% guaranteed bonus with respect to the portion of the 2014 fiscal year that Executive is employed), with respect to the 2014 fiscal year portion of the Interim CFO Period (the “2014 Interim Period”), Executive shall be eligible to receive an additional bonus of up to 25% of Executive’s pro rated base salary with respect to the 2014 Interim Period (the “Supplemental Interim CFO Period

Bonus”), which additional Supplemental Interim CFO Period Bonus shall be earned based on the achievement of goals approved by the compensation committee of the Board (which goals have been delivered to Executive). Further, (i) if the Interim CFO Period extends into the 2015 fiscal year, Executive’s target bonus for the portion of the 2015 fiscal year during which the Interim CFO Period continues shall be 60% of base salary, and (ii) if Executive is not appointed as the Company’s permanent, full-time Chief Financial Officer, then his target bonus as described in the second sentence of this paragraph shall at such time become 45% of base salary prospectively.”

“Further, in connection with Executive’s appointment as Interim Chief Financial Officer as of September 27, 2014, Executive shall receive an additional grant of 6,000 restricted shares of common stock of Parent (vesting annually 25% per year over a 4-year period).”

2. No Other Amendments. Except as otherwise provided herein, the Agreement shall remain in full force and effect in accordance with its original terms.

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IN WITNESS WHEREOF, the parties have executed and delivered this Amendment as of the date first set forth above.