510(k) · Cleared
ClearedEndomap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jun 14, 2002 as substantially equivalent to K010612 (Brainlab AG, 2001) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 2001. 139 later devices descend from it.
- Decided
- Jun 14, 2002
- Review
- 182 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010612 (2001). 2 ancestors in all. 139 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010612 Vectorvision KneeBrainlab AG · 2001
- This deviceK014113 EndomapSiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 135 of its ownK050751 Impax Orthopaedic Workstation, Model Impax ES 5.XAgfa Corp. · 2005 · Recalled
- Descendant · 2 generations on · 133 of its ownK071972 Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007
- Descendant · 3 generations on · 117 of its ownK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- Descendant · 4 generations on · 51 of its ownK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- Descendant · 4 generations on · 28 of its ownK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
Showing 5 of 139 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 139 · See all- K050751Impax Orthopaedic Workstation, Model Impax ES 5.XAgfa Corp. · 2005 · cites it directly135descendants
- K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007 · 2 generations on133descendants
- K073714Traumacad Version 2.0Orthocrat, Ltd. · 2008 · 3 generations on117descendants
- K111019Surgimap (TM) SpineNemaris, Inc. · 2011 · 4 generations on51descendants
- K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| 0 (this device) | K014113 | Endomap | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K050751 | Impax Orthopaedic Workstation, Model Impax ES 5.X | Agfa Corp. | 2005 | 3 |
| +2 | K071972 | Orthopedic Software for Impax Workstations | Agfa Healthcare Corp. | 2007 | — |
| +3 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| +4 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| +4 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 11 | 0 |
| 2022 | 9 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 24 | 0 |
| 2026 | 16 | 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? (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.
What descends from it? (139)
See all 1392 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 EndoMap package is an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. The software is intended to read in diagnostic images (e.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the EndoMap software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014113: Endomap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014113
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026