510(k) · Cleared
ClearedMedtronic Orthopaedic Trauma Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jul 27, 2005 as substantially equivalent to K990214 (Surgical Navigation Technologies, Inc., 1999) and 2 other predicates after a 135-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Jul 27, 2005
- Review
- 135 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K983831 (1999). 5 ancestors in all, the oldest K990214 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 1 generation backK012448 Vectorvision TraumaBrainlab AG · 2002
- This deviceK050651 Medtronic Orthopaedic Trauma ApplicationMedtronic Navigation, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK093206 Orthomap 3D 1.1 ModuleStryker Corp. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093206Orthomap 3D 1.1 ModuleStryker Corp. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −1 | K012448 | Vectorvision Trauma | Brainlab AG | 2002 | — |
| 0 (this device) | K050651 | Medtronic Orthopaedic Trauma Application | Medtronic Navigation, Inc. | 2005 | — |
| +1 | K093206 | Orthomap 3D 1.1 Module | Stryker Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990214 | Fluoronav Module for the Stealthstation SystemSummary page 1…Submitted March 11, 2005 V. Description of Device Modification The Medtronic Orthopaedic Trauma Application software combines existing FluoroNav (1(990214) and Orthopaedic Hip (K(021980) applications used to assist surgeons with the stabilization and repair of orthopa… | 1999 |
| * | K021980 | Hip Module for the Stealthstation SystemSummary page 1…Description of Device Modification The Medtronic Orthopaedic Trauma Application software combines existing FluoroNav (1(990214) and Orthopaedic Hip (K(021980) applications used to assist surgeons with the stabilization and repair of orthopaedic fractures. VI. Substantial Equ… | 2002 |
| * | K012448 | Vectorvision TraumaSummary page 1…he FluoroNav (K(990214) and Orthopaedic Hip (K(021980) applications and is also substantially equivalent to the BrainLab VectorVision Trauma application (K(012448). As required by risk analysis. all verification and validation activities performed by designated individuals and the… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093206 | Orthomap 3D 1.1 Module | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K093206 (Stryker Corp., 2010) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K990214.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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…
Read the full statement (114 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050651: Medtronic Orthopaedic Trauma Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050651
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026