One day back in 2001, Steve Ek, the current CEO of Arthrosurface®, was walking through the machine shop of his former employer, Primo Medical Group, when a metal eye-shield caught his attention. (Eye-shields are used in laser eye surgery to protect the eye from the laser). He noticed how these shields were created with different curvatures to precisely fit the different eye shape of each patient. This prompted Steve to meet with Steve Tallarida, President of Primo Medical Group and current Chairman of the Board at Arthrosurface®, to discuss how this concept of custom fit eye-shields could be applied to treating defects on the surface of the knee (i.e. partial knee replacement surgery).
To explore the concept further, Steve Ek along with some engineers at Primo Medical Group took a series of measurements of the molded eye pieces in two planes: top to bottom and side to side. They discovered they could plug those measurements into a manufacturing machine and it would cut the correctly shaped eye piece every time.
As they were discussing this innovation, Steve Ek had his “A-ha” moment! He realized it was possible to map the surface curvature of the knee joint using a 3-D mapping tool. These mapped out knee joint curvatures could be sent directly to the manufacturing facility to make a custom fit implant that would perfectly match the patient’s joint surface.
To test the hypothesis, Steve made a digital caliper, went to a local lab and mapped a series of coordinates on a cadaver knee. He returned to the manufacturing shop and plugged the mapping coordinates into a machine. A circular piece of metal was then cut to reproduce the exact curves of the knee joint that he had measured. With his new CAP (Contoured Articular Prosthesis) in hand, he returned to the lab and placed the CAP into the knee defect where he had previously mapped the surface. Voila, the implant fit perfectly! The first successful Arthrosurface HemiCAP® implantation was completed!
While having a system this precise to perform partial knee replacement surgery was attractive, it would have required the patient to undergo not one knee surgery but two knee surgeries: one for mapping/measuring the implant and the other for implanting it, which would not be ideal for the patient or any medical system. The final solution became a selection of partial implant size options with many different curvatures which could be brought into the knee surgery and immediately fit to the patient, eliminating the need for a second surgery. Once he had proven that mapping a series of surface coordinates could be turned into a custom fit implant, he proceeded to develop the instruments and surgical procedure to make the HemiCAP® a repeatable and most importantly, one-time procedure.
Arthrosurface® was funded and established by Primo Medical Group, a medical device manufacturing company owned by several of the founding shareholders of Arthrosurface®. Primo Medical Group is an “original equipment manufacturer” (“OEM”) for a number of medical device companies with a strong history of medical product development and enhancement. In addition, Primo Medical Group is registered as a medical device manufacturer with the U.S. Food and Drug Administration (“FDA”) and is certified under ISO 9001 and ISO 13485. Primo Medical Group has successfully introduced 5 companies since 2000 of which two of the four, Angiolink and Spirus Medical, have gone on to be acquired by Medtronic and Olympus, respectively. In 2003, Arthrosurface® entered into an agreement with Boston Millennia Partners, a prestigious and well established Venture Capital company to provide funding and expertise.
More than 15 years later, there are over 100,000 patients that have received an Arthrosurface HemiCAP® implant! Our product portfolio now has over 150 different surface curvatures for the shoulder, hip, knee, ankle and toes along with a new biological system that was launched in 2012 for marrow stimulation/microfracture. A decade after the initial HemiCAP® surgery, Arthrosurface® has become the active alternative to total joint replacement. The Arthrosurface® team consists of experienced individuals in the medical device industry with over 5,000 surgeons using our products in more than 25 countries.
Arthrosurface®, Inc. is a global leader in joint preservation technology, manufacturing less invasive joint replacements that are clinically proven to help patients stay active by increasing range of motion and reducing pain. The company’s product portfolio features more than 150 different surface implant curvatures for the knee, shoulder, hip, ankle, wrist and toe that are designed to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. More than 100,000 patients have been treated with Arthrosurface implants since the company was founded in 2002. Arthrosurface markets and distributes its products in the United States and around the world, with more than 5,000 surgeons currently using Arthrosurface products in more than 25 countries.
Corporate Code of Conduct & Ethics
Purpose: Arthrosurface® Incorporated (“Arthrosurface®”) is a medical device manufacturer engaged in the business of designing, developing, manufacturing, marketing, distributing, and selling orthopedic implants and related products for human implantation in the treatment of orthopedic injuries and disorders. Arthrosurface® is committed to conducting its business activities ethically and lawfully. This Code of Conduct establishes policies and procedures that are intended to guide employees, officers, and directors, and independent sales representatives who provide sales and sales support services to Arthrosurface® in the performance of their duties and responsibilities to ensure compliance with the Company’s commitment to ethical and lawful conduct as well as compliance with the applicable laws and regulations that govern the medical device industry generally. These policies and procedures apply to all employees, officers, and directors of Arthrosurface® and, to the extent that have relevance and are applicable, to independent sales representatives and physician and other third party consultants of Arthrosurface®.
- Compliance. Arthrosurface® will conduct its business affairs and related activities in compliance with all applicable laws, rules, and regulations and in accordance with Arthrosurface® high ethical standards. Arthrosurface® is aware of the need to ensure compliance with those laws, regulations and guidelines which govern Arthrosurface®’s business as well as that of its physician customers, and manufacturer affiliates on whose behalf Arthrosurface® provides services.
- The Workplace. Arthrosurface® will maintain a safe and drug-free work place that is free from discrimination based on race, color, creed, religion, gender, age, disability, national origin, ancestry, citizenship, armed forces service, martial or veteran status, sexual orientation, or any other impermissible favor.
- Designing, Developing, Manufacturing and Selling Products. Arthrosurface® is committed to designing, developing, manufacturing, marketing, distributing, and selling products through its sales representatives in a safe and legally compliant manner. In designing, developing, manufacturing, marketing, distributing, and selling medical devices and related products, Arthrosurface® has established and will comply with standards that meet or exceed the laws and regulations applicable to such activities.
- Competitive Practices. Arthrosurface® will compete for all business opportunities in the marketplace vigorously, fairly, ethically, and legally. Arthrosurface® will comply with all antitrust and other laws regulating competition and trade and will not discuss pricing, cost, production plans, business strategies, or any other proprietary or confidential information with its competitors.
- Marketing and Sales Activities. Arthrosurface® will represent its products and services accurately and will comply with applicable regulatory and legal requirements governing the marketing and sale of its product and services.
- Payments. Neither Arthrosurface® nor its employees, directors, officers, or independent sales representatives will make any improper payments, to government or nongovernment officials, employees, customers, persons, or entities, nor will Arthrosurface® or its employees and directors request or accept any improper payment , from suppliers, customers, or anyone seeking to do business with Arthrosurface®.
- Fair Dealing. Each employee and director will deal fairly with Arthrosurface®’s customers, suppliers, competitors, affiliates, independent auditors, and other employees and will not take unfair advantage of anyone through manipulation, concealment, abuse of privileged information, misrepresentation of material facts, or any other unfair dealing or practice.
- Confidential Information: No employee, director, or independent sales personnel will use, for his or her own personal gain, or disclose to any third party, any confidential or proprietary information that he or she obtained as a result of his or her employment with or relationship to Arthrosurface®. Confidential or proprietary information includes without limitation all non-public information that might be of use to competitors or harmful to Arthrosurface® and its customers if disclosed.
- Corporate Opportunities. Employees, officers, and directors owe a duty to Arthrosurface® to advance its legitimate interests when the opportunity to do so arises. Such personnel are prohibited from (a) taking for themselves personally opportunities that are discovered through the use of corporate property, information, or position, (b) using corporate property, information, or position for personal gain, or (c) competing with Arthrosurface®.
- Conflicts of Interest. No employee or director will engage in any activity or have any outside interest that might deprive the Company of his or her loyalty, interfere with the satisfactory performance of his or her duties, make it difficult to perform his or her duties or the Company objectively and effectively, or be harmful or detrimental to Arthrosurface®. Employees and directors must immediately disclose in writing any actual or potential conflict of interest that they may have to senior management for resolution. A conflict of interest occurs when a person’s private interests interferes or appears to interfere in any way with the Company’s interests and may also arise when an employee or director or a member of his or her family receives improper personal benefits as a result of his or her position with the Company.
- Protection and Proper Use of Company Assets. Theft, carelessness, and waste have a direct impact on the Company’s profitability. All employees and directors will take appropriate actions to protect the Company’s assets and ensure their efficient use for legitimate business purposes.
- Collaboration with Consulting and Designing Physicians. In an effort to ensure the continuous development and commercialization of new products, as well as improvements upon existing products, Arthrosurface® collaborates with members of the physician community in its design, development, and evaluation activities. Arthrosurface® and its employees, officers, and directors will abide by all applicable laws, regulations, and industry guidelines when contracting with, working with, compensating, and otherwise reimbursing physicians in connection with their work for Arthrosurface®. Internal policies and procedures addressing such activities will be routinely reviewed and updated as necessary and all Arthrosurface® personnel will be trained on the applicable policies and procedures. Arthrosurface® will not under any circumstances consider the value or volume of business, if any, generated by any physician with whom Arthrosurface® works and Arthrosurface® will enforce its policies and procedures regarding interactions with such physicians vigorously and without exception.
- Disclosure. Patients who receive or are considering receiving Arthrosurface® products have a right to know if their physician works with Arthrosurface® on product development or related products. Arthrosurface® is committed to ensuring that patients have all information reasonably necessary about Arthrosurface® and their products to make informed decisions about their healthcare. Therefore, Arthrosurface® will make disclosure to the patient population via its external (public) website of those physicians who work with Arthrosurface® and, accordingly, receive compensation from Arthrosurface®, as well as making such disclosure to any health care institution or entity who requests same.
- Compliance: (a) Any violation of this Code of Conduct and any implementing policies and procedures should be reported immediately to the Corporate Compliance Office either in person or via e-mail at email@example.com. Alternately, information can be left anonymously on the Arthrosurface® Compliance Hotline at 866-460-9408. This Hotline is staffed by an independent third party who will then relay only relevant information to the Compliance Office. In any instance, the identity of the person or persons making a report will remain confidential at the election of the individual reporting the violation. (b) Officers, directors, and all other appropriate employees will be required to confirm in writing no less frequently than annually that they understand and are complying with this Code of Conduct and any implementing policies and procedures and that they are not aware of any violation of same or have properly reported all violations. (c) Arthrosurface® will promptly investigate any alleged violation of these policies. Violation of a policy, retaliation against any individual for reporting a violation, or failure to otherwise comply with these policies will not be tolerated and will result in corrective action, including termination of employment where appropriate. Questions concerning this Code of Conduct should be directed to Corporate Compliance Office. The Arthrosurface® Corporate Code of Conduct is hereby adopted and made binding on all employees, officers, directors, and, to the extent applicable, independent sales representatives and physician consultants of Arthrosurface®.
Declaration of Adoption of Comprehensive Compliance Program
Pursuant to California Health and Safety Code Section 119400-119402
Arthrosurface® designs, manufactures and markets orthopedic medical devices. As a medical device manufacturer with a strong commitment to ethical behavior, Arthrosurface® has adopted a Comprehensive Compliance Program in accordance with the Compliance Program Guidance developed by the United States Department of Health and Human Services Office of Inspector General. This Comprehensive Compliance Program includes written standards, employee training, an anonymous hotline, monitoring, a Code of Business Conduct, dedicated compliance office leadership and other elements of an effective program. As an organization we strive to conduct all of our business interactions with healthcare professionals in a compliant and ethical manner. Our Code of Conduct sets out the expectation of behavior expected of all employees and specific sections of the Code of Conduct summarize Arthrosurface® policies regarding interactions with medical or health care professionals. Arthrosurface® has adopted a Compliance Policy for interactions with health care professionals which is based on the Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professionals (the “AdvaMed Code”; effective July 1, 2009), and which regulates the Company’s interactions with health care professionals. Arthrosurface® has supplemented the AdvaMed Code with certain provisions necessary to comply with state laws governing these interactions as appropriate. The Arthrosurface® policies on interacting with Healthcare Professionals establish explicit limits on meals, promotional materials or items or activities that Arthrosurface® or its representatives may give or otherwise provide to an individual medical or health care professional. To the best of our knowledge, Arthrosurface® is in all material respects in compliance with a Comprehensive Compliance Program (“CCP”) that satisfies the requirements of California Health and Safety Code §§ 119400-119402, based on our good faith understanding of the statutory provisions as they may apply to a medical device manufacturer. Questions on the Code of Conduct, our Comprehensive Compliance Program, requests for materials or any additional questions can be directed to our Compliance Office at 508-520-3003 or firstname.lastname@example.org.
Reviewed and Updated 2015