510(k) · Cleared
ClearedOrtho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
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 13, 2023 as substantially equivalent to K162341 (Stryker Leibinger GmbH & Co KG, 2016) and 3 other predicates after a 60-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it.
- Decided
- Feb 13, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K993239 (2000). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 6 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 5 generations backK141551 Profess Software, Profess Curved 70 (Degrees) Suction, Profess…Stryker Corporate · 2014 · Recalled
- 4 generations backK153240 Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
- 3 generations backK162341 Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016
- 2 generations backK172034 Stryker Spine Navigation System with SpineMap 3D software…Stryker Corporation · 2017
- 1 generation backK220593 Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022
- This deviceK223767 Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee…Stryker Leibinger GmbH & Co KG · 2023
- Descendant · cites it directly · 0 of its ownK233542 Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee…Stryker Leibinger GmbH & Co KG · 2024
Most influential descendants
Showing 1 of 1 · See all- K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −6 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −5 | K141551 | Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70… | Stryker Corporate | 2014 | 1 |
| −4 | K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | 2016 | — |
| −3 | K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016 | — |
| −2 | K172034 | Stryker Spine Navigation System with SpineMap 3D software application… | Stryker Corporation | 2017 | — |
| −1 | K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | 2022 | — |
| 0 (this device) | K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software… | Stryker Leibinger GmbH & Co KG | 2023 | — |
| +1 | K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software… | Stryker Leibinger GmbH & Co KG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K162341 | Stryker OrthoMap Precision Knee systemSummary page 5…Stryker OrthoMap Stryker Leibinger Precision Knee Precision Knee 5.0 K162341 OLO GmbH & Co. KG Software… | 2016 |
| * | K153240 | Styrker OrthoMap Express Knee SystemSummary page 5…Stryker OrthoMap Stryker Leibinger Express Knee Express Knee 2.0 K153240 OLO GmbH & Co. KG Software… | 2016 |
| * | K162937 | Stryker OrthoMap Versatile Hip SystemSummary page 5…Stryker OrthoMap Stryker Leibinger Versatile Hip Versatile Hip 2.0 K162937 OLO GmbH & Co. KG Software… | 2017 |
| * | K220593 | Spine Guidance Software, Stryker Q Guidance SystemSummary page 5…Software Application Ortho Q Guidance Stryker Q Guidance Stryker Leibinger K220593 OLO System System GmbH & Co. KG… | 2022 |
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 |
|---|---|---|---|
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho… | 2024 | 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 23 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 17 ancestors have a recall of any class.
- Of its descendants, K233542 (Stryker Leibinger GmbH & Co KG, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K162341.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Ortho Q Guidance System, with the Ortho Guidance Precision Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate. TThe Stryker Ortho Q…
Read the full statement (297 words)
The Stryker Ortho Q Guidance System, with the Ortho Guidance Precision Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.
TThe Stryker Ortho Q Guidance System, with the Ortho Guidance Express Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.
The Stryker Ortho Q Guidance System, with the Ortho Guidance Versatile Hip Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure, such as but not limited to the pelvis or femur, can be identified. The system is indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate. The system is indicated for the following surgical procedures:
- Total hip arthroplasty (THA)
- Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery
- Revisions
The Stryker Ortho Q Guidance System is intended as an aid for precisely locating anatomical structures in open computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223767 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223767: Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223767
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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