510(k) · Cleared
ClearedADAPT for Gamma3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · OLO Orthopedic Stereotaxic Instrument
Cleared on May 2, 2018 as substantially equivalent to K103400 (Stryker Corporation, 2011) after a 126-day review. Its family tree reaches back 10 generations to 1994. 1 of the 42 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- May 2, 2018
- Review
- 126 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K911783 (1994). 39 ancestors in all, the oldest K811452 (1981). 2 later devices descend from it, 1 citing it directly. 1 of the 42 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 6 generations between
- 3 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 2 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 1 generation backK103400 Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt)…Stryker Corporation · 2011
- This deviceK173946 ADAPT for Gamma3Stryker GmbH · 2018
- Descendant · cites it directly · 1 of its ownK181848 ADAPT for Gamma3, Gamma3Stryker GmbH · 2018
- Descendant · 2 generations on · 0 of its ownK202749 ADAPT for Gamma3Stryker GmbH · 2020
Show all 10 generations
- Root · 10 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 9 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 8 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 7 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 6 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 5 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 4 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 3 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 2 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 1 generation backK103400 Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt)…Stryker Corporation · 2011
- This deviceK173946 ADAPT for Gamma3Stryker GmbH · 2018
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System5 generations back · 2001
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −9 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −8 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −7 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −6 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −5 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −4 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −3 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −2 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −1 | K103400 | Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip | Stryker Corporation | 2011 | — |
| 0 (this device) | K173946 | ADAPT for Gamma3 | Stryker GmbH | 2018 | — |
| +1 | K181848 | ADAPT for Gamma3, Gamma3 | Stryker GmbH | 2018 | — |
| +2 | 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 | 1 | 0 |
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K103400 | Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipSummary page 5…ional 510(k) Premarket Notification Stryker GmbH III. PREDICATE DEVICE ADAPT for Gamma3 Primary predicate: FluoroMap Computer Assisted Surgery System (K103400) IV. DEVICE DESCRIPTION This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the AD… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181848 | ADAPT for Gamma3, Gamma3 | 2018 | 1 |
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 · 5 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 8 of the 39 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K181848 (Stryker GmbH, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K103400.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 ADAPT for Gamma3 System, when used with the Stryker Navigation System, assists the surgeon to determine the needed size and position of orthopedic implants during femur fracture surgery using the Gamma3 System.
When used in operation 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/K173946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173946: ADAPT for Gamma3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173946
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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