510(k) · Cleared
ClearedBrainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Sep 5, 2008 as substantially equivalent to K021306 (Brainlab AG, 2002) and 2 other predicates after a 254-day review. Its family tree reaches back 5 generations to 1999. 52 later devices descend from it.
- Decided
- Sep 5, 2008
- Review
- 254 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K983831 (1999). 9 ancestors in all. 52 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 4 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 3 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 2 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 1 generation backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- This deviceK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- Descendant · cites it directly · 41 of its ownK091411 Kneealign SystemOrthalign, Inc. · 2009
- Descendant · cites it directly · 40 of its ownK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- Descendant · 2 generations on · 39 of its ownK103829 Kneealign SystemOrthalign, Inc. · 2011
- Descendant · 3 generations on · 31 of its ownK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- Descendant · 4 generations on · 29 of its ownK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K091411Kneealign SystemOrthalign, Inc. · 2009 · cites it directly41descendants
- K093998Kneealign System with Reference SensorOrthalign, Inc. · 2010 · cites it directly40descendants
- K103829Kneealign SystemOrthalign, Inc. · 2011 · 2 generations on39descendants
- K130387Orthoalign Plus SystemOrthalign, Inc. · 2013 · 3 generations on31descendants
- K140331Orthalign Plus SystemOrthalign, Inc. · 2014 · 4 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −4 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −3 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −2 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −1 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| 0 (this device) | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| +1 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| +1 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| +2 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| +3 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| +4 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K021306 | Vectorvision CT-Free KneeSummary page 1…: BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Devices: Vector Vision® CT-fr Knee (K021306) Ci TKR/UKR (K0529 VectorVision uni-kn/e (K041899) Device Classificati Name: Instrument, Stereotaxic Regulatory Class: lass II… | 2002 |
| * | K052966 | CI Knee, CI MI TKRSummary page 2…ubstantially equivalent with predicate devices such as the 510(k)-clearance of VectorVision -free knee (K021306), VectorVision® Uni-Knee (K041899) and of Ci TKR/UKR (K052966). Page 2 of 2… | 2006 |
| * | K041899 | Vectorvision Uni-KneeSummary page 1…em / Instrument, Stereotaxic Predicate Devices: Vector Vision® CT-fr Knee (K021306) Ci TKR/UKR (K0529 VectorVision uni-kn/e (K041899) Device Classificati Name: Instrument, Stereotaxic Regulatory Class: lass II Intended Us BrainLA nee is intended to be a… | 2004 |
What descends from it? (52)
See all 525 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 9 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K091411 (Orthalign, Inc., 2009) has gone furthest, with 41 descendants of its own.
- 9 other devices also cite its predicate K021306.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 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 BrainLAB 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/K073615 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073615: Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073615
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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