510(k) · Cleared
ClearedFluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 7, 2011 as substantially equivalent to K062358 (Brainlab AG, 2007) and 3 other predicates after a 108-day review. Its family tree reaches back 9 generations to 1994. 1 of the 44 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Mar 7, 2011
- Review
- 108 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K911783 (1994). 38 ancestors in all, the oldest K811452 (1981). 5 later devices descend from it, 2 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 5 generations between
- 3 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 2 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 1 generation backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- This deviceK103400 Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt)…Stryker Corporation · 2011
- Descendant · cites it directly · 2 of its ownK173946 ADAPT for Gamma3Stryker GmbH · 2018
- Descendant · cites it directly · 1 of its ownK182359 HipCheckStryker Corp. · 2018
- Descendant · 2 generations on · 1 of its ownK181848 ADAPT for Gamma3, Gamma3Stryker GmbH · 2018
- Descendant · 2 generations on · 0 of its ownK230045 HipCheckStryker Corp. · 2023
- Descendant · 3 generations on · 0 of its ownK202749 ADAPT for Gamma3Stryker GmbH · 2020
Show all 9 generations
- Root · 9 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 8 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 7 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 6 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 5 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 4 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 3 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 2 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 1 generation backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- This deviceK103400 Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt)…Stryker Corporation · 2011
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System4 generations back · 2001
Most influential descendants
Showing 5 of 5 · See all- K173946ADAPT for Gamma3Stryker GmbH · 2018 · cites it directly2descendants
- K182359HipCheckStryker Corp. · 2018 · cites it directly1descendant
- K181848ADAPT for Gamma3, Gamma3Stryker GmbH · 2018 · 2 generations on1descendant
- K230045HipCheckStryker Corp. · 2023 · 2 generations on0descendants
- K202749ADAPT for Gamma3Stryker GmbH · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −8 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −7 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −6 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −5 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −4 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −3 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −2 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −1 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| 0 (this device) | K103400 | Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip | Stryker Corporation | 2011 | — |
| +1 | K173946 | ADAPT for Gamma3 | Stryker GmbH | 2018 | — |
| +1 | K182359 | HipCheck | Stryker Corp. | 2018 | — |
| +2 | K181848 | ADAPT for Gamma3, Gamma3 | Stryker GmbH | 2018 | — |
| +2 | K230045 | HipCheck | Stryker Corp. | 2023 | — |
| +3 | K202749 | ADAPT for Gamma3 | Stryker GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 1 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K062358 | Modification to Vectorvision TraumaSummary page 1…assification panel Orthopedic and Radiology Regulation §882.4560 Product Code(s) OLO and LLZ Legally marketed VectorVision trauma from BrainLAB AG, K062358 device(s) to which TenZing System from Mazor Surgical Technologies Ltd., K1 021 30 equivalence is Gamma3 Lag Screw fr… | 2007 |
| * | K102130 | Tenzing SystemSummary page 1…ode(s) OLO and LLZ Legally marketed VectorVision trauma from BrainLAB AG, K062358 device(s) to which TenZing System from Mazor Surgical Technologies Ltd., K1 021 30 equivalence is Gamma3 Lag Screw from Stryker Trauma GmbH, K020677 claimed Gamma3 Trochanteric Nail from St… | 2010 |
| * | K020677 | Gamma 3 Lag ScrewSummary page 1…nLAB AG, K062358 device(s) to which TenZing System from Mazor Surgical Technologies Ltd., K1 021 30 equivalence is Gamma3 Lag Screw from Stryker Trauma GmbH, K020677 claimed Gamma3 Trochanteric Nail from Stryker Trauma GmbH, K032244 Reason for 510(k) Traditional 510(k) Notif… | 2002 |
| * | K032244 | Gamma 3 Nail SystemSummary page 1…ogies Ltd., K1 021 30 equivalence is Gamma3 Lag Screw from Stryker Trauma GmbH, K020677 claimed Gamma3 Trochanteric Nail from Stryker Trauma GmbH, K032244 Reason for 510(k) Traditional 510(k) Notification submission Device description The FluoroMap System is designed as a co… | 2003 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 38 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K173946 (Stryker GmbH, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K062358.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
FluoroMap is a computer controlled stereotaxic image guided surgery system. It provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual implants and instruments onto those X-ray images.
FluoroMap assists the surgeon to determine the needed size and position of orthopedic implants during proximal femur fracture surgery using the Stryker Gamma3 Nail system. The system should be operated only by trained personnel such as surgeons and clinic staff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103400: Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103400
Report an extraction error
Are you the manufacturer?
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