510(k) · Cleared
ClearedBrainlab Knee Arthroscopy
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 Jun 11, 2010 as substantially equivalent to K042512 (Brainlab AG, 2005) and 1 other predicate after a 252-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Jun 11, 2010
- Review
- 252 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K983831 (1999). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 4 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 3 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 2 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 1 generation backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- This deviceK093118 Brainlab Knee ArthroscopyBrainlab AG · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −4 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −3 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −2 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −1 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| 0 (this device) | K093118 | Brainlab Knee Arthroscopy | Brainlab AG | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K042512 | Vectorvision AclSummary page 1…lassification Name: BrainLAB Image Guided Surgery System! Instrument, Stereotaxic Predicate Device: VectorVision® ACL (K042512) BrainLAB Knee (K073615) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 1I Intended Use: Indicati… | 2005 |
| * | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedSummary page 1…BrainLAB Image Guided Surgery System! Instrument, Stereotaxic Predicate Device: VectorVision® ACL (K042512) BrainLAB Knee (K073615) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 1I Intended Use: Indications For Use: BrainLAB A… | 2008 |
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 11 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 3 other devices also cite its predicate K042512.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 AOL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to a virtual computer image space on the model of a bone, overlaid with individually acquired patient landmarks.
The system is indicated for any surgical anterior cruciate ligament procedure in which the use of stereotactic surgery for the planning and navigation of interosseous canals may be appropriate, and where a reference to a rigid anatomical structure can be established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093118 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093118: Brainlab Knee Arthroscopy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093118
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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