510(k) · Cleared
ClearedOrtho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co KG · OLO Orthopedic Stereotaxic Instrument
Cleared on Feb 19, 2009 as substantially equivalent to K062640 (Stryker Instruments, 2006) and 1 other predicate after a 133-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Feb 19, 2009
- Review
- 133 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993239 (2000). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 1 generation backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- This deviceK083009 Ortho-Map-Oncology Navigation Software, Models 6005-650-000…Stryker Leibinger GmbH & Co KG · 2009
- 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 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −1 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| 0 (this device) | K083009 | Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000 | Stryker Leibinger GmbH & Co KG | 2009 | — |
| +1 | K093206 | Orthomap 3D 1.1 Module | Stryker Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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 OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000Summary page 2…* Navigated intra-operative screw placement based on pre-planned or intra-operative virtual screw definition Equivalent to: K062640 Cranial Module K012380 Spine & Fluoroscopy Module Substantial Equivalence: The Stryker Navigation S… | 2006 |
| * | K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual FluoroscopySummary page 2…d on pre-planned or intra-operative virtual screw definition Equivalent to: K062640 Cranial Module K012380 Spine & Fluoroscopy Module Substantial Equivalence: The Stryker Navigation System - OrthoMap® 3D Module… | 2001 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 4 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.
- 4 other devices also cite its predicate K062640.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The Stryker Navigation System - OrthoMap® 3D Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified. The system should be operated only by…
Read the full statement (295 words)
The Stryker Navigation System - OrthoMap® 3D Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
The system should be operated only by trained personnel such as surgeons and clinic staff. The Stryker Navigation System - OrthoMap® 3D Module supports, but is not limited to, the following surgical procedures:
Orthopedic Oncology Procedures
Surgical Planning Procedures
* Segmentation to define volumes of interest using correlated, multi-modality image data, e.g. to assist outlining and visualizing bony structures such as aberrant pathology
* Image based distance and angular measurement tools, e.g. to define and maintain safety margins to outlined bony structures
* Image based resection plane planning to define resections relative to identified structures, e.g. to support limb salvage surgery taking safety margins into account
* Virtual screw placement planning in the image data with variable screw length, head-length and diameter
* Image based annotation point placement and visualization, e.g. to support repositioning of bony anatomic points during surgery
Surgical Navigation Procedures
* Intra-operative visualization of volume image data including visualization of pre-planned volumes of interest relative to the tracked instrument, supporting navigated excision of user-defined bony structures
* Intra-operative visualization of resection planes relative to the tracked instrument on bony structures assisting bony resections
* Intra-operative creation and visualization of annotation points, supporting recording of landmarks on bony anatomy, e.g. to assist oncology replacement prosthesis repositioning, leg length and rotation assessment or navigated implant placement
* Navigated intra-operative screw placement based on pre-planned or intra-operative virtual screw definition
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083009: Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083009
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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