510(k) · Cleared
ClearedBrainlab Hip Unlimited, CI Hip Unlimited
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 Apr 8, 2009 as substantially equivalent to K040368 (Brainlab AG, 2004) and 4 other predicates after a 135-day review. Its family tree reaches back 5 generations to 2001. 70 later devices descend from it.
- Decided
- Apr 8, 2009
- Review
- 135 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K010612 (2001). 14 ancestors in all, the oldest K983831 (1999). 70 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 4 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 3 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 2 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 1 generation backK060468 Vectorvision HipBrainlab AG · 2006
- This deviceK083483 Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG · 2009
- Descendant · cites it directly · 47 of its ownK110021 Dash HipBrainlab AG · 2011
- Descendant · 2 generations on · 29 of its ownK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- Descendant · cites it directly · 27 of its ownK110204 Brainlab TraumaBrainlab AG · 2011
- Descendant · 3 generations on · 18 of its ownK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- Descendant · 4 generations on · 15 of its ownK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K110021Dash HipBrainlab AG · 2011 · cites it directly47descendants
- K140331Orthalign Plus SystemOrthalign, Inc. · 2014 · 2 generations on29descendants
- K110204Brainlab TraumaBrainlab AG · 2011 · cites it directly27descendants
- K153237OrthAlign Plus SystemOrthalign, Inc. · 2016 · 3 generations on18descendants
- K162962OrthAlign Plus SystemOrthalign, Inc. · 2017 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −4 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −3 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −2 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −1 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| 0 (this device) | K083483 | Brainlab Hip Unlimited, CI Hip Unlimited | Brainlab AG | 2009 | — |
| +1 | K110021 | Dash Hip | Brainlab AG | 2011 | — |
| +2 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| +1 | K110204 | Brainlab Trauma | Brainlab AG | 2011 | — |
| +3 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| +4 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 8 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 10 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 12 | 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? (5)
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 |
|---|---|---|---|
| * | K040368 | Vectorvision Hip 3.0Summary page 1…imited, Ci hip unlimited Common/Classification Name: BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Devices: VectorVision® hip (K040368) Navigation Software hip 3.1 on Ci (K052213) VectorVision® hip V3.1, Biomet integration (K060468) VectorVision® hip 4.0 (K060727)… | 2004 |
| * | K052213 | Navigation SW Hip 3.1 on CISummary page 1…on Name: BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Devices: VectorVision® hip (K040368) Navigation Software hip 3.1 on Ci (K052213) VectorVision® hip V3.1, Biomet integration (K060468) VectorVision® hip 4.0 (K060727) VectorVision® hip V3.1, DePuy integration (… | 2005 |
| * | K060468 | Vectorvision HipSummary page 1…System / Instrument, Stereotaxic Predicate Devices: VectorVision® hip (K040368) Navigation Software hip 3.1 on Ci (K052213) VectorVision® hip V3.1, Biomet integration (K060468) VectorVision® hip 4.0 (K060727) VectorVision® hip V3.1, DePuy integration (K072716) Device Classification Name: Instrument, Ste… | 2006 |
| * | K060727 | Vectorvision HipSummary page 1…c Predicate Devices: VectorVision® hip (K040368) Navigation Software hip 3.1 on Ci (K052213) VectorVision® hip V3.1, Biomet integration (K060468) VectorVision® hip 4.0 (K060727) VectorVision® hip V3.1, DePuy integration (K072716) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class… | 2006 |
| * | K072716 | Vector Vision HipSummary page 1…vigation Software hip 3.1 on Ci (K052213) VectorVision® hip V3.1, Biomet integration (K060468) VectorVision® hip 4.0 (K060727) VectorVision® hip V3.1, DePuy integration (K072716) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Intended Use: BrainLAB hip unlimited is intend… | 2007 |
What descends from it? (70)
See all 703 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 8 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K110021 (Brainlab AG, 2011) has gone furthest, with 47 descendants of its own.
- 11 other devices also cite its predicate K040368.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
BrainLAB hip unlimited 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 either on a patient's preoperative image data being processed by a VectorVision or a CiTM workstation or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone…
Read the full statement (170 words)
BrainLAB hip unlimited 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 either on a patient's preoperative image data being processed by a VectorVision or a CiTM workstation or 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 safe and effective and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprothesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement (TJR)
Revision surgery of TJR
Minimally Invasive Orthopedic Surgery
Tumor resection and bone/joint reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083483: Brainlab Hip Unlimited, CI Hip Unlimited.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083483
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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