Search Results

The Stryker OrthoMap Versatile Hip system, which is comprised of the OrthoMap Versatile Hip 2.0 Software and a platform of the NAV3i platform family, is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery.

The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

The system is indicated for conditions of the hip joint in which the use of image guided surgery may be appropriate.

The Stryker OrthoMap Versatile Hip system is indicated for the following surgical procedures:

· Any form of Total Hip Athroplasty (THA), e.g. open or minimally-invasive

• · Precisely position instruments, implants and bony tissue during orthopedic hip surgery
  · Revisions

The Stryker OrthoMap Versatile Hip system is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model of the patient's hip (pelvis and femur). The computed model is based on an intra-operative anatomy survey of the pelvis and leg as described in the following chapters. The system consists of a Stryker surgical software application (software), which runs on a platform, consisting of a Stryker computer (computer), a navigation camera, an IO-Tablet and a monitor. The Stryker surgical software application interfaces with smart instruments (e.g. patient trackers, instrument trackers or pointers) and several accessories enabling the tracking of surgical instruments.

The Stryker OrthoMap Versatile Hip software, as well as the dedicated instruments, are compatible and represent an open platform for different implant systems. The Stryker OrthoMap Versatile Hip software provides alignment and orientation of instruments, trials and ultimately implants. The system also enables intra-operative and post implantation assessments of the patient's joint stability, ROM, and leg length and leg offset.

The Stryker OrthoMap Versatile Hip software allows the user to customize workflow by selecting to navigate either the cup, the stem, or both. The user settings can be adjusted to match the surgeon's preferences. The Stryker Navigation System enables navigation of dedicated Stryker Cup and Stem Instruments as well as generic navigation of various major cup instruments.

The Stryker OrthoMap Versatile Hip 2.0 Software is compatible with the NAV3i Platform Family. The NAV3i platform family is a family of platforms that, when used with a surgical software application, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient.

The provided text describes the Stryker OrthoMap Versatile Hip System and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device