510(k) · Cleared
ClearedKnee 3
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 3, 2022 as substantially equivalent to K102990 (Brainlab AG, 2011) and 2 other predicates after an 88-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Jun 3, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K983831 (1999). 22 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK220652 Knee 3Brainlab AG · 2022
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) | K220652 | Knee 3 | Brainlab AG | 2022 | — |
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 |
| 2008 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K102990 | Brainlab KneeSummary page 4…Regulatory Class II Panel Orthopedic Predicate Devices Primary predicate device: Brainlab Knee (Knee 2.5) K102990 Secondary predicate device: uni-Knee (Uni-Knee 2.0) K080678… | 2011 |
| * | K080678 | Uni-Knee 2.0Summary page 4…Devices Primary predicate device: Brainlab Knee (Knee 2.5) K102990 Secondary predicate device: uni-Knee (Uni-Knee 2.0) K080678 Tertiary predicate device: DASH Knee (DASH Knee 1.0) (K102251)… | 2008 |
| * | K102251 | Dash KneeSummary page 4…Secondary predicate device: uni-Knee (Uni-Knee 2.0) K080678 Tertiary predicate device: DASH Knee (DASH Knee 1.0) (K102251) Contact Information Primary Contact… | 2011 |
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 23 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- 3 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K102990.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Knee3 is intended to be an intraoperative localization system used during orthopedic knee surgery. It links a navigated instrument, tracked by a passive marker sensor system, to virtual computer image space on an individually acquired model of the patient's anatomical axes, which are generated through acquiring multiple anatomical bony landmarks. The system is indicated for medical conditions in which the use of stereotaxic surgery may be appropriate and…
Read the full statement (119 words)
Knee3 is intended to be an intraoperative localization system used during orthopedic knee surgery. It links a navigated instrument, tracked by a passive marker sensor system, to virtual computer image space on an individually acquired model of the patient's anatomical axes, which are generated through acquiring multiple anatomical bony landmarks. The system is indicated for medical conditions in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the femur and tibia, can be identified relative to the acquired anatomical landmarks. The system aids the surgeon to plan resections, measure cutting block alignment, measure bone resections, and/or leg alignment. The device is indicated for total and uni-compartmental knee replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220652: Knee 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220652
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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