510(k) · Cleared
Recalled · Class II · 2016Brainlab Knee
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 4, 2011 as substantially equivalent to K073615 (Brainlab AG, 2008) and 1 other predicate after a 178-day review. Its family tree reaches back 6 generations to 1999. 7 later devices descend from it. It has been recalled once.
- Decided
- Apr 4, 2011
- Review
- 178 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K983831 (1999). 19 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- 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 deviceK102990 Brainlab KneeBrainlab AG · 2011
- Descendant · cites it directly · 5 of its ownK122011 Navigation Software Hip-Universal; Navigation Software Hip…Brainlab AG · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK181449 Ortoma Treatment Solution - OTSOrtoma AB · 2018
- Descendant · 3 generations on · 2 of its ownK232140 OTS HipOrtoma AB · 2024 · Recalled
- Descendant · 4 generations on · 1 of its ownK250086 OTS HipOrtoma AB · 2025 · Recalled
- Descendant · 5 generations on · 0 of its ownK261852 OTS HipOrtoma AB · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG · 2012 · cites it directly5descendants
- K181449Ortoma Treatment Solution - OTSOrtoma AB · 2018 · 2 generations on3descendants
- K232140OTS HipOrtoma AB · 2024 · 3 generations on2descendants
- K250086OTS HipOrtoma AB · 2025 · 4 generations on1descendant
- K261852OTS HipOrtoma AB · 2026 · 5 generations on0descendants
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) | K102990 | Brainlab Knee | Brainlab AG | 2011 | — |
| +1 | K122011 | Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap | Brainlab AG | 2012 | 1 |
| +2 | K181449 | Ortoma Treatment Solution - OTS | Ortoma AB | 2018 | — |
| +3 | K232140 | OTS Hip | Ortoma AB | 2024 | 1 |
| +4 | K250086 | OTS Hip | Ortoma AB | 2025 | 1 |
| +5 | K261852 | OTS Hip | Ortoma AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedSummary page 1…System / Instrument, Stereotaxic Regulation Number: 21 CER 852.4560 Product code: OLO Predicate Device: Brainlab knee (K07361 5) PiGalileo Total Knee Replacement (TKR) System (K061 362) Device Classification Name: Instrument, Stereotaxic Regulatory Class:… | 2008 |
| * | K061362 | Pigalileo Total Knee Replacement (TKR) SystemSummary page 1…mber: 21 CER 852.4560 Product code: OLO Predicate Device: Brainlab knee (K07361 5) PiGalileo Total Knee Replacement (TKR) System (K061 362) Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class 11 Intended Use: Brainlab knee is intended to be… | 2006 |
What descends from it? (7)
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 |
|---|---|---|---|---|
| Oct 27, 2016 | Class II | Z-0959-2017 | Mixed-up of materials/components | Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K122011 (Brainlab AG, 2012) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K073615.
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?
Brainlab Knee 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 appropriate…
Read the full statement (155 words)
Brainlab Knee 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 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, MR-based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Brainilb Knee.
Example orthopedic surgical procedures include but are not limited to:
* Total Knee Replacement
* Ligament Balancing
* Range of Motion Analysis
* Patella Tracking
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102990: Brainlab Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102990
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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