510(k) · Cleared
ClearedNavbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suite 201, National Innovation Centre · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 30, 2026 as substantially equivalent to K200376 (Navbit Pty, Ltd., 2020) after a 91-day review. Its family tree reaches back 16 generations to 1999.
- Decided
- Jul 30, 2026
- Review
- 91 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K983831 (1999). 53 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 12 generations between
- 3 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK200376 Navbit Sprint System- Supine Registration, Navbit Sprint Kit -…Navbit Pty, Ltd. · 2020
- This deviceK261410 Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT…Suite 201, National Innovation Centre · 2026
Show all 16 generations
- Root · 16 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 15 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 14 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 13 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 12 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 11 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 10 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 9 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 8 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 7 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 6 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 5 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 4 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 3 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK200376 Navbit Sprint System- Supine Registration, Navbit Sprint Kit -…Navbit Pty, Ltd. · 2020
- This deviceK261410 Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT…Suite 201, National Innovation Centre · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −15 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −14 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −13 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −12 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −11 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −10 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −9 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −8 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −7 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −6 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −5 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| −4 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −3 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −2 | K172462 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −1 | K200376 | Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral… | Navbit Pty, Ltd. | 2020 | — |
| 0 (this device) | K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral… | Suite 201, National Innovation Centre | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K200376 | Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationSummary page 5…21 CFR 882.4560 Common/Usual Name Stereotaxic instrument Proprietary Name Navbit MARQ Predicate Device(s) Navbit Sprint (K200376) Reason for Submission New Device 2. Intended Use and Indications for Use For Lateral Patient Registration The Navb… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 53 ancestors have a recall of any class.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Navbit MARQ System is a computer-controlled system intended to assist the surgeon in determining alignment in relation to reference axes during orthopedic surgical procedures. The Navbit MARQ System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit MARQ System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the…
Read the full statement (110 words)
The Navbit MARQ System is a computer-controlled system intended to assist the surgeon in determining alignment in relation to reference axes during orthopedic surgical procedures. The Navbit MARQ System facilitates the accurate positioning of implants, relative to these alignment axes.
The clinical setting and target population for the Navbit MARQ System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine or lateral decubitus position.
The Navbit MARQ System is indicated for use:
- in Hip Arthroplasty surgical procedures;
- with acetabular cups that are uncemented and allow for post-impaction correction;
- when post-impaction confirmatory measurement checks can be obtained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261410: Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261410
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026