SIGN Fracture Care International is a 501(c)(3) non-profit medical device manufacturing organization founded by Lewis Greer Zirkle Jr. Zirkle established SIGN after he patented a set of orthopaedic implants and instruments for use in low-resource hospitals. SIGN now manufactures and donates these instruments and implants to partner hospitals in low- and middle-income countries (LMIC). In addition to the distribution of orthopaedic products, SIGN provides surgical education to doctors operating in LMIC.

History In 1968 Zirkle was drafted into the United States Army to serve in the ongoing Vietnam War. While operating as a surgeon with the 93rd Evacuation Hospital, Zirkle treated wounded American and Vietnamese soldiers. Eventually, he began operating on Vietnamese civilians.

After returning from Vietnam, Zirkle rotated through several hospitals while finishing his Army contract. During this time, he sought more ways to treat injured people in LMIC. In 1972, Zirkle traveled to Indonesia to provide training for local orthopaedic surgeons. Along with traveling, he also brought donations of medical equipment to the Indonesian hospitals. It wasn't until 1996, when Zirkle encountered a patient who had been bed-ridden for three years due to a fractured femur, that he questioned the effectiveness of his travels. Zirkle questioned the Indonesian surgeon overseeing the patient as to why surgery had not been performed. The surgeon informed him that the patient could not afford an implant, nor were the supplied implants suitable for use. This interaction led Zirkle to realize another solution was needed to treat patients who live in LMIC.

Zirkle recognized that providing training for surgeons was inadequate without also supplying usable implants and instruments. To accomplish this goal, he needed to partner with a US-based surgical implant manufacturing company. After many rejections, Dr. Zirkle connected with Portland-based Acumed, Inc. Along with Acumed engineers, Zirkle created a preliminary set of intramedullary (IM) nails and instruments that Zirkle took to Vietnam. After receiving instruction in the SIGN system, the Vietnamese surgeons demonstrated their ability to use the nails.

SIGN officially launched on 29 January 1999. By September, Dr. Zirkle had set up a small shop in Richland, Washington with a manual lathe and a mill for metal working. Dr. Zirkle and Acumed founder Randall Huebner handcrafted two IM nails in Richland, which Huebner took to Acumed headquarters for mass production. By the end of 1999, the SIGN technique was piloted in four hospitals (two in Vietnam, one in Indonesia, and one in Nepal).

Operations

Medical Device Manufacturing SIGN's Pediatric Fin Nail uses the fin design, but is scaled to fit in the bones of younger patients and avoids using screws in growth centers of the bone, allowing the patient to grow during healing and avoiding long-term complications.

SIGN manufactures a system of orthopaedic instruments used to insert the nail and stabilize it with interlocking screws. This system does not rely on live-view C-arm x-ray systems in the operating room. Instead, SIGN's Target Arm and Slot Finder guide insertion of the nail and positions screws for stabilization.

SIGN is registered with the United States Food and Drug Administration (FDA). SIGN manufactures finished medical devices in compliance with the Code of Federal Regulations, FDA Quality Management System Regulation.

Patents SIGN Instruments and Implants patented with the United States Patent and Trademarks Office include:

SIGN Hip Construct (US-8157803-B1) SIGN Target Arm and Slot Finder (US-20020151897-A1, US-20040082955-A1, and US-7066943-B2) SIGN Bone Fixation System (US-10441317-B2)

Surgeon education SIGN partners with surgeons based in LMIC by providing orthopaedic education opportunities. SIGN hosts an annual conference for international surgeons and partners with global orthopaedic partners to provide regional trainings.

SIGN Surgical Database The SIGN Surgical Database is an online platform composed of patient information, pre-operative x-rays, and post-operative x-rays plus any comments the surgeon has about the case. Follow-up appointments are added to the case entry to track healing progress. Once a case is uploaded, experienced surgeons will review the procedure. The reviewers provide feedback to the surgeon, both on what they did well and any areas of improvement.

Annual SIGN International Orthopaedic Conference The Annual SIGN International Orthopaedic Conference has been held in Richland nearly every year since 2001. During the COVID-19 pandemic, the in-person conference was canceled with leadership opting to instead use online training tools. The SIGN Conference began as a way for Dr. Zirkle to present SIGN's mission to US-based orthopaedic surgeons. In 2004, LMIC surgeons attended the SIGN Conference for the first time, representing Kenya and India. As the conference grew over time, the focus shifted from promotional to educational. Currently, the conference is attended by surgeons from low-resource countries who want to enhance their surgical skills.

Activities by Location As of January 2025, SIGN partners with more than 5,000 surgeons at 447 hospitals in 60 countries. Surgeons trained by SIGN have cared for more than 450,000 patients with fractures since 1999 .

Countries with active SIGN programs by region +AfricaCountry # of ProgramsActive SinceAngola12013Benin12021Burkina Faso12022Burundi82010Cameroon62007Chad42012Dem. Rep. of the Congo62012Eswatini12024Ethiopia502009Gabonese Republic12010Ghana62014Guinea22019Kenya192007Lesotho12022Liberia42007Madagascar12020Malawi62007Mali12016Niger22007Nigeria182007Rwanda52007Sierra Leone22009Somalia22021Somaliland42019South Sudan32012Tanzania382007The Gambia12017Togo12014Uganda92010Zambia22013Zimbabwe62012 +AmericasCountry# of ProgramsActive SinceDominican Republic 42007Ecuador32007Haiti172007Honduras32016Nicaragua22007Peru22007Saint Lucia12007Venezuela12019 +AsiaCountry# of ProgramsActive SinceAfghanistan 212007Armenia32020Bangladesh82007Bhutan22007Cambodia172007India12007Indonesia32007Iraq22007Lao PDR42012Mongolia22008Myanmar162007Nepal102007Pakistan92007The Philippines102007Vietnam12007Yemen12021 +OceaniaCountry# of ProgramsActive SincePalau12024Papua New Guinea 12018Solomon Islands12014 +EuropeCountry# of ProgramsActive SinceBosnia and Hezegovina12024Ukraine 132022

Awards and honors

2010: Smart Map Expo Manufacturer of the Year Award 2013: US Patents and Trademark Office Patents for Humanity Award, Medical—Diagnostics & Devices Category 2024: ESOT Institutional Award

References