Search Results
Found 2 results
510(k) Data Aggregation
(132 days)
Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile
Ortho Guidance Precision Knee Software:
The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative quidance system to enable open computer-assisted surgerv. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.
Ortho Guidance Express Knee Software:
The Stryker quidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.
Ortho Guidance Versatile Hip Software:
The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery.
The systems 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 systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate.
The system is indicated for the following surgical procedures:
-
Total Hip Arthroplasty (THA)
-
Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery
-
Revisions
Q Guidance System:
The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified.
The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.
Here's a breakdown of the acceptance criteria and the study information for the Stryker Q Guidance System and its associated software, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy (point) | Mean accuracy of 2 mm point displacement within the registration zone. |
| System Accuracy (angular) | Mean accuracy of 2° angular axis displacement within the registration zone. |
| Trueness for LED fiducial (mean Euclidean error) | $\le 150 \mu m$ |
| Trueness for LED fiducial (95% percentile of Euclidean error) | $ |
Ask a specific question about this device
(60 days)
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile
Ortho Guidance Precision Knee Software:
The Stryker Ortho Q Guidance System, with the Ortho Guidance Precision Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.
Ortho Guidance Express Knee Software:
TThe Stryker Ortho Q Guidance System, with the Ortho Guidance Express Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.
Ortho Guidance Versatile Hip Software:
The Stryker Ortho Q Guidance System, with the Ortho Guidance Versatile Hip Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted 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 computer-assisted surgery may be appropriate. The system is indicated for the following surgical procedures:
-
Total hip arthroplasty (THA)
-
Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery
-
Revisions
Ortho Q Guidance System:
The Stryker Ortho Q Guidance System is intended as an aid for precisely locating anatomical structures in open computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.
The purpose of this Traditional 510(k) submission is to seek clearance for 3 new software applications and 1 new guidance system. The applications have been created for functionality on the new guidance system in scope of this submission. The subject devices in scope of this submission are outlined in Table 6-1 with the predicate information in Table 6-2. The devices in scope of this submission, Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and the Ortho Q Guidance System work within an ecosystem with a host of other existing smart devices and accessories that will be demonstrated to be compatible with the subject devices but are not in scope of this submission.
The Ortho Guidance Precision Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Precision Knee System. The Ortho Guidance Express Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Express Knee System. The Ortho Guidance Versatile Hip Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Versatile Hip System.
The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.
Ask a specific question about this device
Page 1 of 1