510(k) · Cleared
ClearedOrtho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; 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 Mar 14, 2024 as substantially equivalent to K223767 (Stryker Leibinger GmbH & Co KG, 2023) and 1 other predicate after a 132-day review. Its family tree reaches back 8 generations to 2000. 4 of the 34 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 14, 2024
- Review
- 132 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K993239 (2000). 33 ancestors in all, the oldest K971247 (1997). No later device cites it as a predicate yet. 4 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 7 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 6 generations backK141551 Profess Software, Profess Curved 70 (Degrees) Suction, Profess…Stryker Corporate · 2014 · Recalled
- 5 generations backK153240 Styrker OrthoMap Express Knee SystemStryker Corporate · 2016
- 4 generations backK162341 Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG · 2016
- 3 generations backK172034 Stryker Spine Navigation System with SpineMap 3D software…Stryker Corporation · 2017
- 2 generations backK220593 Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG · 2022
- 1 generation backK223767 Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee…Stryker Leibinger GmbH & Co KG · 2023
- This deviceK233542 Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee…Stryker Leibinger GmbH & Co KG · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −7 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −6 | K141551 | Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70… | Stryker Corporate | 2014 | 1 |
| −5 | K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | 2016 | — |
| −4 | K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016 | — |
| −3 | K172034 | Stryker Spine Navigation System with SpineMap 3D software application… | Stryker Corporation | 2017 | — |
| −2 | K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | 2022 | — |
| −1 | K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software… | Stryker Leibinger GmbH & Co KG | 2023 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 1 |
| 2016 | 1 | 1 |
| 2017 | 3 | 1 |
| 2020 | 1 | 0 |
| 2021 | 2 | 1 |
| 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.
4 devices in this family have 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Summary page 5…The following are the legally marketed predicate devices for the subject devices included in this Traditional 510(k). The primary predicate device is K223767. Table 2: Predicate Device List Predicate Device… | 2023 |
| * | K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Summary page 5…Co. KG Software Stryker Leibinger Q Guidance System Q Guidance System K212194 HAW GmbH & Co. KG… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K212397StealthStation S8 Cranial v2.0Medtronic Navigation · 2021 · 2 generations back · ◆ in the 2021 ancestors bar of FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 2 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 17 of the 33 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Ortho Guidance Precision Knee Software: The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be…
Read the full statement (325 words)
Ortho Guidance Precision Knee Software:
The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.
Ortho Guidance Express Knee Software:
The Stryker guidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.
Ortho Guidance Versatile Hip Software:
The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery.
The systems 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 systems are 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
Q Guidance System:
The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance 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 femur, tibia, or long bone can be identified.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233542: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233542
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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