Item 1A. Risk Factors

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You should carefully consider the factors discussed in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2021 (“2021 Form 10-K”) and the factors discussed below, which could materially affect our business, financial condition and results of operations. Except as set forth below, there have been no material changes in those risk factors. The risks described in our 2021 Form 10-K and below are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or results of operations. In addition, the COVID-19 pandemic could exacerbate or trigger other risks discussed in our 2021 Form 10-K and below, any of which could materially affect our business, financial condition and results of operations.

The risk factor in our 2021 Form 10-K entitled “We conduct a significant amount of our sales activity outside of the U.S., which subjects us to additional business risks and may cause our profitability to decline due to increased costs” is replaced in its entirety by the following:

We conduct a significant amount of our sales activity outside of the U.S., which subjects us to additional business risks and may cause our profitability to decline due to increased costs.

We sell our products in more than 100 countries and derived approximately 40 percent of our net sales in 2021 from outside the U.S. We intend to continue to pursue growth opportunities in sales internationally, including in emerging markets, which could expose us to additional risks associated with international sales and operations. Our international operations are, and will continue to be, subject to a number of risks and potential costs, including:

	•	changes in foreign medical reimbursement policies and programs;

	•	changes in foreign regulatory requirements, such as more stringent requirements for regulatory clearance of products;

	•	differing local product preferences and product requirements;

	•	fluctuations in foreign currency exchange rates;

	•	the effects of inflation, including the effects of different rates of inflation in different countries, on our costs and the costs of our products;

	•	diminished protection of intellectual property in some countries outside of the U.S.;

	•	trade protection measures, import or export requirements, new or increased tariffs, trade embargoes and sanctions and other trade barriers, which may prevent us from shipping products to a particular market, restrict our access to certain sources of raw materials, increase our operating costs and disrupt our ability to collect payment for our products and services in particular markets;

	•	foreign exchange controls that might prevent us from repatriating cash earned in countries outside the U.S.;

	•	complex data privacy and cybersecurity requirements and labor relations laws;

	•	extraterritorial effects of U.S. laws such as the FCPA;

	•	effects of foreign anti-corruption laws, such as the UK Bribery Act;

	•	difficulty in staffing and managing foreign operations;

	•	labor force instability;

	•	potentially negative consequences from changes in tax laws; and

	•	political, social and economic instability and uncertainty, including wars, other conflict and sovereign debt issues.

Violations of foreign laws or regulations could result in fines, criminal sanctions against us, our officers or our employees, prohibitions on the conduct of our business and damage to our reputation.

Wars and other conflicts may increase certain of these risks and may adversely affect our business and financial performance. For example, the U.S. and other countries have imposed sanctions on Russia, certain of its businesses and certain individuals due to the invasion of Ukraine, and additional sanctions may continue to be imposed. Sanctions, and other related civil, political and economic effects of the Russia-Ukraine crisis, may have adverse impacts globally, including supply chain continuity disruption; inflationary pressures and increased costs of raw materials and inputs, especially titanium used in our products; manufacturing or shipping delays; increased shipping costs; and increased disruptions and delays on our ability to collect payment for our products and services in

particular markets. While Russia and Ukraine do not constitute material portions of our business, a significant escalation or expansion of economic disruption or the conflict’s current scope could adversely affect our result of operations.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | --- | --- |

None

Item 3. Defaults Upon Senior Securities | --- | --- |

None

Item 4. Mine Safety Disclosures | --- | --- |

Not applicable

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