# K050651: Medtronic Orthopaedic Trauma Application

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Jul 27, 2005 after 135 days
- Product code: HAW (Neurological 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: 2 generations back to K983831 (1999). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990214: Fluoronav Module for the Stealthstation System, Surgical Navigation Technologies, Inc. (1999) Summary page 1.
- K021980: Hip Module for the Stealthstation System, Medtronic Surgical Navigation Technologies (2002) Summary page 1.
- K012448: Vectorvision Trauma, Brainlab AG (2002) Summary page 1.

## Most influential descendants
- K093206: Orthomap 3D 1.1 Module (2010), 0 descendants of its own

## Indications for use
The Orthopaedic Trauma Application is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Orthopaedic Trauma Application is indicated for trauma procedures in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, pelvis or vertebra can be identified relative to a CT or MR based model, digitized landmarks or fluoroscopy images of the anatomy * Acetabular, femoral and tibia fractures * Guide Wire placement Implant/Hardware Remo~'al Intertrochanteric Fractures Intramedullary Nailing Long-bone Fracture Fixation Long-bone Fracture Reduction Pelvic Fracture Fixation * Pelvic Fracture Reduction * Screw/Implant Placement * Tibial, Femoral and Acetabular Osteotomies

Source page: https://510kreport.com/device/K050651
Methodology: https://510kreport.com/methodology