SIGN Fracture Care
| Company type | 501(c)(3) nonprofit organization |
|---|---|
| Industry | Medical devices |
| Founded | January 29, 1999 |
| Founder | Lewis Greer Zirkle Jr. |
| Headquarters | Richland , United States |
| Products | Orthopedic implants (intramedullary nails), surgical instruments, training programs |
SIGN Fracture Care International operates as a 501(c)(3) nonprofit organization specializing in the production of medical devices. Founded by Lewis Greer Zirkle Jr. following his development of orthopedic implants and tools tailored for hospitals with limited resources, SIGN both manufactures and donates these products to affiliated medical centers in low- and middle-income countries (LMIC). Alongside product provision, SIGN offers surgical training programs to healthcare professionals in these regions.
History
During the Vietnam War in 1968, Zirkle was conscripted into the United States Army, where he served as a surgeon at the 93rd Evacuation Hospital. His duties involved treating military personnel and Vietnamese civilians alike. After completing his military service, Zirkle dedicated himself to enhancing orthopedic care in LMIC by traveling to Indonesia in 1972 to provide surgeon training and donate medical equipment.
A defining event occurred in 1996 when Zirkle met a patient immobilized for three years due to an untreated femoral fracture. The attending local surgeon cited the absence of affordable and appropriate implants as the cause. This encounter underscored the necessity not only for surgical education but also for accessible implants and instruments.
To meet this challenge, Zirkle collaborated with Portland-based manufacturer Acumed, Inc. Together, they engineered intramedullary (IM) nails and related instruments, which were successfully introduced to surgeons practicing in Vietnam.
SIGN was formally established on January 29, 1999, launching a modest manufacturing facility in Richland, Washington. By the end of that year, the SIGN system was implemented on a trial basis at four hospitals located in Vietnam, Indonesia, and Nepal.
Medical Device Manufacturing
SIGN is responsible for designing, producing, and donating intramedullary nails used to treat fractures of the femur, tibia, and humerus. The SIGN Nail consists of a solid stainless-steel rod inserted into the medullary canal of the bone and secured with screws. Manufactured in multiple lengths and diameters, it accommodates diverse patient anatomies. The SIGN Fin Nail variant employs flanged fins rather than distal interlocking screws to achieve fixation within the bone canal.
The Pediatric Fin Nail adapts this flanged fin concept for younger patients by avoiding screw placement near growth plates, thereby supporting natural bone development during healing.
In addition to implants, SIGN produces an orthopedic instrumentation set designed for nail insertion and stabilization without dependence on real-time C-arm fluoroscopy. Tools such as the Target Arm and Slot Finder assist surgeons in accurately placing nails and screws, improving procedural effectiveness.
SIGN holds registration with the U.S. Food and Drug Administration (FDA) and manufactures finished medical devices adhering to FDA Quality System Regulation requirements.
Patents
SIGN Instruments and Implants possess multiple patents registered with the USPTO, such as:
- SIGN Hip Construct (US-8157803-B1)
- SIGN Target Arm and Slot Finder (US-20020151897-A1, US-20040082955-A1, US-7066943-B2)
- SIGN Bone Fixation System (US-10441317-B2)
Surgeon Education
To strengthen its business model, SIGN collaborates with surgeons in low- and middle-income countries (LMICs) by providing orthopaedic training programs. The organization organizes an annual global conference and partners with international orthopaedic bodies to offer regional educational workshops, thereby expanding its professional reach and market presence.
SIGN Surgical Database
The SIGN Surgical Database is an exclusive digital platform that aggregates patient information, including pre- and post-operative radiographs and surgeon observations. This resource enhances quality control by allowing seasoned surgeons to evaluate cases and offer valuable feedback, supporting SIGN’s leadership in surgical education and product utilization.
Annual SIGN International Orthopaedic Conference
Since 2001, SIGN has convened its Annual International Orthopaedic Conference in Richland, which serves as a pivotal occasion for guiding global strategy and operations. Originally designed to promote the company’s mission to U.S.-based surgeons, the event broadened in 2004 to welcome surgeons from Kenya and India representing LMICs. Currently, the conference emphasizes advanced surgical training tailored for healthcare providers in resource-constrained environments. During the COVID-19 crisis, SIGN demonstrated adaptability by transitioning to virtual training platforms, ensuring continuous growth and operational resilience.
Activities by Location
By January 2025, SIGN had established partnerships with more than 5,000 surgeons across 447 hospitals in 60 countries. Since 1999, these trained surgeons have treated over 450,000 patients with fractures.
Countries with Active SIGN Programs by Region
Tanzania 38 2007| Country | Number of Programs | Year Active Since |
|---|---|---|
| Angola | 1 | 2013 |
| Benin | 1 | 2021 |
| Burkina Faso | 1 | 2022 |
| Burundi | 8 | 2010 |
| Cameroon | 6 | 2007 |
| Chad | 4 | 2012 |
| Democratic Republic of the Congo | 6 | 2012 |
| Eswatini | 1 | 2024 |
| Ethiopia | 50 | 2009 |
| Gabon | 1 | 2010 |
| Ghana | 6 | 2014 |
| Guinea | 2 | 2019 |
| Kenya | 19 | 2007 |
| Lesotho | 1 | 2022 |
| Liberia | 4 | 2007 |
| Madagascar | 1 | 2020 |
| Malawi | 6 | 2007 |
| Mali | 1 | 2016 |
| Niger | 2 | 2007 |
| Nigeria | 18 | 2007 |
| Rwanda | 5 | 2007 |
| Sierra Leone | 2 | 2009 |
| Somalia | 2 | 2021 |
| Somaliland | 4 | 2019 |
| South Sudan
3 2012 |
Awards and Honors
- 2010: Manufacturer of the Year Award at Smart Map Expo
- 2013: Patents for Humanity Award from the US Patent and Trademark Office in the Medical—Diagnostics & Devices sector
- 2024: Institutional Award presented by ESOT