510(k) · Cleared
ClearedStryker OrthoMap Versatile Hip System
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 Feb 23, 2017 as substantially equivalent to K022365 (Stryker Instruments, 2003) after a 126-day review. Its family tree reaches back 1 generation to 2003. 9 later devices descend from it.
- Decided
- Feb 23, 2017
- Review
- 126 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022365 (2003). 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK022365 Stryker Navigation System - Hip ModuleStryker Instruments · 2003 · Recalled
- This deviceK162937 Stryker OrthoMap Versatile Hip SystemStryker Corporation · 2017
- Descendant · cites it directly · 3 of its ownK171525 Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK213380 360CASKico Knee Innovation Company Pty Limited · 2022
- Descendant · 2 generations on · 2 of its ownK191507 Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK223767 Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee…Stryker Leibinger GmbH & Co KG · 2023
- Descendant · 2 generations on · 1 of its ownK223927 360CASKico Knee Innovation Company Pty Limited · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017 · cites it directly3descendants
- K213380360CASKico Knee Innovation Company Pty Limited · 2022 · cites it directly2descendants
- K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019 · 2 generations on2descendants
- K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG · 2023 · cites it directly1descendant
- K223927360CASKico Knee Innovation Company Pty Limited · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022365 | Stryker Navigation System - Hip Module | Stryker Instruments | 2003 | 10 |
| 0 (this device) | K162937 | Stryker OrthoMap Versatile Hip System | Stryker Corporation | 2017 | — |
| +1 | K171525 | Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. | 2017 | — |
| +1 | K213380 | 360CAS | Kico Knee Innovation Company Pty Limited | 2022 | — |
| +2 | K191507 | Intellijoint® Navigation System | Intellijoint Surgical, Inc. | 2019 | 2 |
| +1 | K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software… | Stryker Leibinger GmbH & Co KG | 2023 | — |
| +2 | K223927 | 360CAS | Kico Knee Innovation Company Pty Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K022365 | Stryker Navigation System - Hip ModuleSummary page 4…ic Instrument Panel: Orthopedic Product Code: OLO - Orthopedic Stereotaxic Instrument Predicate Device: K022365 – Stryker Navigation System – Hip Module… | 2003 |
What descends from it? (9)
3 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 OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 OrthoMap Versatile Hip system, which is comprised of the OrthoMap Versatile Hip 2.0 Software and a platform of the NAV3i platform family, is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided 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…
Read the full statement (130 words)
The Stryker OrthoMap Versatile Hip system, which is comprised of the OrthoMap Versatile Hip 2.0 Software and a platform of the NAV3i platform family, is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided 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 image guided surgery may be appropriate.
The Stryker OrthoMap Versatile Hip system is indicated for the following surgical procedures:
• Any form of Total Hip Athroplasty (THA), e.g. open or minimally-invasive
• Precisely position instruments, implants and bony tissue during orthopedic hip surgery
• Revisions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162937 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162937: Stryker OrthoMap Versatile Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162937
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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