510(k) · Cleared
ClearedOrthomap 3D 1.1 Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · OLO Orthopedic Stereotaxic Instrument
Cleared on Aug 4, 2010 as substantially equivalent to K083009 (Stryker Leibinger GmbH & Co KG, 2009) and 3 other predicates after a 295-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Aug 4, 2010
- Review
- 295 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K983831 (1999). 15 ancestors in all, the oldest K990214 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −2 | K012448 | Vectorvision Trauma | Brainlab AG | 2002 | — |
| −1 | K042512 | Vectorvision Acl | Brainlab AG | 2005 | — |
| 0 (this device) | 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 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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? (4)
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 |
|---|---|---|---|
| * | K083009 | Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000Summary page 2…ended use and performance to the following predicate devices: * Stryker Navigation System - OrthoMap® 3D Module (K083009) * Stryker Navigation System - Cranial Module (K062640) * BrainLAB Ve… | 2009 |
| * | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000Summary page 2…es: * Stryker Navigation System - OrthoMap® 3D Module (K083009) * Stryker Navigation System - Cranial Module (K062640) * BrainLAB VectorVision® AOL (K042512) * Medtronic Orthopaedic Traum… | 2006 |
| * | K042512 | Vectorvision AclSummary page 2…Map® 3D Module (K083009) * Stryker Navigation System - Cranial Module (K062640) * BrainLAB VectorVision® AOL (K042512) * Medtronic Orthopaedic Trauma Application (K050651) The following veri… | 2005 |
| * | K050651 | Medtronic Orthopaedic Trauma ApplicationSummary page 2…- Cranial Module (K062640) * BrainLAB VectorVision® AOL (K042512) * Medtronic Orthopaedic Trauma Application (K050651) The following verification and validation activities were performed: Performance Testing *Benc… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 15 ancestors have a recall of any class.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 - OrthoMapo 3D 1.1 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 intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system offers the following…
Read the full statement (155 words)
The Stryker Navigation System - OrthoMapo 3D 1.1 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 intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system offers the following features and functions:
* Import of multi-modality image data
* Surgical planning, such as image manipulation and visualization and procedural planning
* Surgical navigation, such as manual and automatic registration and precise. positioning of instruments and implants
The system should be operated only by trained personnel such as surgeons and clinic staff.
The system can assist surgeons in the following, but not limited to, orthopedic surgical procedures:
* Orthopedic oncology procedures
* Cam type FAI (femoroacetabular impingement) surgery
* AOL (anterior cruciate ligament) reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093206: Orthomap 3D 1.1 Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093206
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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