510(k) · Cleared
ClearedDash Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 18, 2011 as substantially equivalent to K083483 (Brainlab AG, 2009) and 1 other predicate after a 288-day review. Its family tree reaches back 6 generations to 2001. 47 later devices descend from it.
- Decided
- Oct 18, 2011
- Review
- 288 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K010612 (2001). 15 ancestors in all, the oldest K983831 (1999). 47 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 5 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 4 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 3 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 2 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 1 generation backK083483 Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009
- This deviceK110021 Dash HipBrainlab AG · 2011
- Descendant · cites it directly · 29 of its ownK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- Descendant · 2 generations on · 18 of its ownK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- Descendant · 3 generations on · 15 of its ownK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- Descendant · 4 generations on · 12 of its ownK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- Descendant · cites it directly · 10 of its ownK133759 Intellijoint HipIntellijoint Surgical, Inc. · 2014
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K140331Orthalign Plus SystemOrthalign, Inc. · 2014 · cites it directly29descendants
- K153237OrthAlign Plus SystemOrthalign, Inc. · 2016 · 2 generations on18descendants
- K162962OrthAlign Plus SystemOrthalign, Inc. · 2017 · 3 generations on15descendants
- K171780OrthAlign Plus SystemOrthalign, Inc. · 2017 · 4 generations on12descendants
- K133759Intellijoint HipIntellijoint Surgical, Inc. · 2014 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −5 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −4 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −3 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −2 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −1 | K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | Brainlab AG | 2009 | — |
| 0 (this device) | K110021 | Dash Hip | Brainlab AG | 2011 | — |
| +1 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| +2 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| +3 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| +4 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| +1 | K133759 | Intellijoint Hip | Intellijoint Surgical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K083483 | Brainlab Hip Unlimited, CI Hip UnlimitedSummary page 1…n Name: BrainLAB DASH, BrainLAB Image Guided Surgery SystemI Instrument, Stereotaxic Predicate Device: BrainLAB hip unlimited (K083483) Kolibri Image Guided Surgery System (KOl 4256) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 11… | 2009 |
| * | K014256 | Kolibri Igs Systems | 2002 |
What descends from it? (47)
See all 473 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?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K140331 (Orthalign, Inc., 2014) has gone furthest, with 29 descendants of its own.
- 2 other devices also cite its predicate K083483.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
DASH hip is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be…
Read the full statement (130 words)
DASH hip is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface.
The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be sate and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.
Example orthopedic surgical procedures include but are not limited to:
Total Hip Replacement (THR)
Revision surgery of THR
Minimally Invasive THR Surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110021: Dash Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110021
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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