510(k) · Cleared
ClearedNavbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navbit Pty, Ltd. · OLO Orthopedic Stereotaxic Instrument
Cleared on Dec 10, 2020 as substantially equivalent to K172462 (Orthalign, Inc., 2017) after a 296-day review. Its family tree reaches back 15 generations to 1999. 1 later device descends from it.
- Decided
- Dec 10, 2020
- Review
- 296 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K983831 (1999). 52 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 11 generations between
- 3 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK200376 Navbit Sprint System- Supine Registration, Navbit Sprint Kit -…Navbit Pty, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK261410 Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT…Suite 201, National Innovation Centre · 2026
Show all 15 generations
- Root · 15 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 14 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 13 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 12 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 11 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 10 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 9 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 8 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 7 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 6 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 5 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 4 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 3 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK200376 Navbit Sprint System- Supine Registration, Navbit Sprint Kit -…Navbit Pty, Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −14 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −13 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −12 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −11 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −10 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −9 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −8 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −7 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −6 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −5 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −4 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| −3 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −2 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −1 | K172462 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| 0 (this device) | K200376 | Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral… | Navbit Pty, Ltd. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K172462 | OrthAlign Plus SystemSummary page 4…Stereotaxic instrument. Proprietary Name Navbit® Sprint Predicate Device(s) OrthAlign Plus® System (K172462) Reason for submission New Device Navbit® Sprint 510(k)… | 2017 |
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 |
|---|---|---|---|
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration… | 2026 | 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 21 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 52 ancestors have a recall of any class.
- Of its descendants, K261410 (Suite 201, National Innovation Centre, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K172462.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
For Lateral Patient Registration: The Navbit® Sprint 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® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty…
Read the full statement (231 words)
For Lateral Patient Registration:
The Navbit® Sprint 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® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.
The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a lateral decubitus position.
The Navbit® Sprint System for lateral patient registration 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.
For Supine Patient Registration:
The Navbit® Sprint 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® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.
The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position.
The Navbit® Sprint System for supine patient registration 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/K200376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200376: Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200376
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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