510(k) · Cleared
Recalled · Class II · 2015Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap
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 Nov 15, 2012 as substantially equivalent to K083483 (Brainlab AG, 2009) and 4 other predicates after a 129-day review. Its family tree reaches back 7 generations to 1999. 5 later devices descend from it. It has been recalled once.
- Decided
- Nov 15, 2012
- Review
- 129 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 7 generations to K983831 (1999). 35 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 6 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 5 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 4 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 3 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 2 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 1 generation backK102990 Brainlab KneeBrainlab AG · 2011 · Recalled
- This deviceK122011 Navigation Software Hip-Universal; Navigation Software Hip…Brainlab AG · 2012
- Descendant · cites it directly · 3 of its ownK181449 Ortoma Treatment Solution - OTSOrtoma AB · 2018
- Descendant · 2 generations on · 2 of its ownK232140 OTS HipOrtoma AB · 2024 · Recalled
- Descendant · 3 generations on · 1 of its ownK250086 OTS HipOrtoma AB · 2025 · Recalled
- Descendant · 4 generations on · 0 of its ownK261852 OTS HipOrtoma AB · 2026
- Descendant · cites it directly · 0 of its ownK193307 HIP7Brainlab AG · 2020
Most influential descendants
Showing 5 of 5 · See all- K181449Ortoma Treatment Solution - OTSOrtoma AB · 2018 · cites it directly3descendants
- K232140OTS HipOrtoma AB · 2024 · 2 generations on2descendants
- K250086OTS HipOrtoma AB · 2025 · 3 generations on1descendant
- K261852OTS HipOrtoma AB · 2026 · 4 generations on0descendants
- K193307HIP7Brainlab AG · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −6 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −5 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −4 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −3 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −2 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −1 | K102990 | Brainlab Knee | Brainlab AG | 2011 | 1 |
| 0 (this device) | K122011 | Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap | Brainlab AG | 2012 | — |
| +1 | K181449 | Ortoma Treatment Solution - OTS | Ortoma AB | 2018 | — |
| +2 | K232140 | OTS Hip | Ortoma AB | 2024 | 1 |
| +3 | K250086 | OTS Hip | Ortoma AB | 2025 | 1 |
| +4 | K261852 | OTS Hip | Ortoma AB | 2026 | — |
| +1 | K193307 | HIP7 | Brainlab AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K083483 | Brainlab Hip Unlimited, CI Hip UnlimitedSummary page 1…ip Unlimited US Common/Classification Brainlab Hip, Brainlab Image Guided Surgery System /Instrument, Stereotaxic Name: Predicate Device: BrainLAB hip unlimited (K083483) Vector Vision@ hip SR (K(063028) DASH hip (K1 1002 1) Br… | 2009 |
| * | K063028 | Vectorvision Hip SRSummary page 3…equivalent with the predicate devices: * BrainLAB hip unlimited (K083483) * Vector Vision@ hip SIR (K063028) * DASH hip (K1 10021) * Brainlab Knee (K1 02990)… | 2006 |
| * | K110021 | Dash HipSummary page 1…nt, Stereotaxic Name: Predicate Device: BrainLAB hip unlimited (K083483) Vector Vision@ hip SR (K(063028) DASH hip (K1 1002 1) Brainlab Knee (K1 02990) Brainlab Trauma (1110204) Device Classification Instr… | 2011 |
| * | K102990 | Brainlab KneeSummary page 1…nLAB hip unlimited (K083483) Vector Vision@ hip SR (K(063028) DASH hip (K1 1002 1) Brainlab Knee (K1 02990) Brainlab Trauma (1110204) Device Classification Instrument, Stereotaxic Name: Regulatory Class:… | 2011 |
| * | K110204 | Brainlab TraumaSummary page 3…SIR (K063028) * DASH hip (K1 10021) * Brainlab Knee (K1 02990) " Brainlab Trauma (K1 10204) Changes to Predicate Device: Brainlab Hip has changed in the following from the predicate devices:… | 2011 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2015 | Class II | Z-1215-2015 | Reprocessing Controls | The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- 4 of the 35 ancestors have a recall of any class.
- Of its descendants, K181449 (Ortoma AB, 2018) has gone furthest, with 3 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. 2012, 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?
Total Hip Replacement (THR) procedures The Brainlab Hip system 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 Brainlab IGS platforms, or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple…
Read the full statement (325 words)
Total Hip Replacement (THR) procedures
The Brainlab Hip system 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 Brainlab IGS platforms, 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, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement
Minimally invasive orthopedic surgery
Tumor resection and bone/joint reconstruction
Surface Replacement (SR) procedures
The Brainlab Hip system is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on Brainlab IGS platforms. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by 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 appropriate 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, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to:
Partial/hemi-hip resurfacing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122011 · printed Nov 3, 2026
Cite this page
510(k) Report. “K122011: Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K122011
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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