# K233542: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Mar 14, 2024 after 132 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K993239 (2000). 33 ancestors in all.
No later device cites it as a predicate yet.
4 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223767: Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System, Stryker Leibinger GmbH & Co KG (2023) Summary page 5.
- K212194: Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System, Stryker Corporation (2023) Summary page 5.

## Indications for use
Ortho Guidance Precision Knee Software: The Stryker guidance systems, with the Ortho Guidance Precision 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 Express Knee Software: The Stryker guidance 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.

Source page: https://510kreport.com/device/K233542
Methodology: https://510kreport.com/methodology