ROBODOC at the Smithsonian
Last year, THINK Surgical donated some early ROBODOC prototypes to the Smithsonians, and the Smithoni Guide to the Records by Alison Oswald was made public.
Smithsonian National Museum of American History - Guide to the records
"The collection documents the development of ROBODOC, the first robot to perform surgery on a human in the United States through correspondence, memoranda, press clippings, press releases, engineering drawings, regulatory policies and procedures, photographs, and audiovisual materials.
"The collection documents the development of ROBODOC, the first robot to perform surgery on a human in the United States through correspondence, memoranda, press clippings, press releases, engineering drawings, regulatory policies and procedures, photographs, and audiovisual materials.
Historical
ROBODOC was the first robot to perform surgery in the United States. It was developed in 1986 by IBM’s Thomas J. Watson Research Center, and researchers at the University of California, Davis.
They formed a collaborative initiative to develop a surgical device for Total Hip Arthroplasty (THA). The team included William Bargar, M.D., Howard “Hap” Paul, D.V.M (1949- 1993), and engineers, Brent Mittelstadt and Peter Kazanides. See US Patent 5,769,092 for Computer-aided system for revision total hip replacement surgery and US Patent 5,806,518 for Method and system of positioning surgical robot, 1998. The original company, Integrated Surgical Systems (ISS) was incorporated in 1990.
The goal of ISS was to create a robotic surgical system that would redefine precision joint replacement procedures. Drilling into bone by hand is not always precise, and often requires glue to fill in empty spaces. Additionally there is a danger the bone will splinter. In this regard, ROBODOC is similar to computer-controlled machine tools. ROBODOC “mills” the bone or joint for accurate fitting similar to machine tools.
In May of 1990 the device was successfully tested on dogs. Since 1998 when it received 510 (K) clearance from the U.S. Food and Drug Administration for Total Hip Arthroplasty over 28,000 procedures have been performed worldwide.
ROBODOC was eventually sold in 2007 to Novatrix Biomedical, Inc. which formed Curexo Medical, Inc. to handle the acquisition of Integrated Surgical Systems, Inc. (ISS). ISS became THINK Surgical, Inc. in 2014.
ROBODOC was the first robot to perform surgery in the United States. It was developed in 1986 by IBM’s Thomas J. Watson Research Center, and researchers at the University of California, Davis.
They formed a collaborative initiative to develop a surgical device for Total Hip Arthroplasty (THA). The team included William Bargar, M.D., Howard “Hap” Paul, D.V.M (1949- 1993), and engineers, Brent Mittelstadt and Peter Kazanides. See US Patent 5,769,092 for Computer-aided system for revision total hip replacement surgery and US Patent 5,806,518 for Method and system of positioning surgical robot, 1998. The original company, Integrated Surgical Systems (ISS) was incorporated in 1990.
The goal of ISS was to create a robotic surgical system that would redefine precision joint replacement procedures. Drilling into bone by hand is not always precise, and often requires glue to fill in empty spaces. Additionally there is a danger the bone will splinter. In this regard, ROBODOC is similar to computer-controlled machine tools. ROBODOC “mills” the bone or joint for accurate fitting similar to machine tools.
In May of 1990 the device was successfully tested on dogs. Since 1998 when it received 510 (K) clearance from the U.S. Food and Drug Administration for Total Hip Arthroplasty over 28,000 procedures have been performed worldwide.
ROBODOC was eventually sold in 2007 to Novatrix Biomedical, Inc. which formed Curexo Medical, Inc. to handle the acquisition of Integrated Surgical Systems, Inc. (ISS). ISS became THINK Surgical, Inc. in 2014.
Scope and Content Note
The collection documents the development of ROBODOC, a robotic surgical system that would redefine precision joint replacement procedures. The collection contains correspondence, memoranda, press clippings, press releases, engineering drawings, regulatory policies and procedures, photographs, and audiovisual materials documenting the development of the ROBODOC. The collection is strong in documentation about regulatory policies and procedures the company undertook for approval from the Food and Drug Administration.
The collection is divided into six series:
The collection is divided into six series:
- Series 1: Project History and Background Materials, 1985-2003
- This series consists of background materials and the history of the project primarily through correspondence. Integrated Surgical Systems (ISS) , Inc., of Sacramento California was established in 1992 to develop computer-based, image-driven, surgical robotics systems. The company integrates sophisticated imaging and robotics technologies into precision application-oriented tools for exacting surgical procedures.
The company grew out of by Dr. Howard A. "Hap" Paul (1949-1993) and orthopaedic surgeon Dr. William Bargar collaboration with IBM's Thomas J. Watson Research Center and the University of California, Davis. In 1990, Robodoc Surgical Assistant System was successfully used by Dr. Paul to perform the world's first robotic-assisted total hip replacement surgery on a dog. ISS began a limited feasibility study of Robodoc, authorized by the Food and Drug Administration for human surgery from 1992-1993 at Sutter General Hospital. The Robodoc™ System consists of two integrated components which comprise the single turnkey system, the Orthodo™c preoperative planning workstation and Robodoc™, the computer controlled surgical robot - Series 2: Engineering Materials, 1989-2000, bulk 1991-1993
- This series consists of drawings, correspondence, memoranda, and notes detailing the development of the Robodoc™. The meeting summaries and design review documents provide insight into the review and decision making process for various aspects of development.
- Series 3: User Guides, 1991-2001
- Series 4: Food and Drug Administration, 1987-2001
- This series consists of materials related to Food and Drug Administration (FDA) approval of Robodoc™ Surgical Assistant System. The materials include primarily correspondence, clinical trial data and agreements, notes, articles, study protocols, patient consent forms, clinical study case report forms and other materials created for institutional review committees. Many of the clinical trial documents provide condensed information about the device (Robodoc) protocols used, risk analysis, monitoring procedures, and consent forms. Also included is correspondence with Advanced Biosearch Associates (ABA), a contract Food and Drug Administration (FDA) regulatory and clinical research firm. ABA was founded in 1979 and is based in Danville, California.
- Series 5: Press Clippings, 1983-2010
- Series 6: Audiovisual Materials, 1988-2009"
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