510(k) · Cleared
ClearedCI TKR/Ukr
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 Aug 12, 2003 as substantially equivalent to K021306 (Brainlab AG, 2002) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 1999. 134 later devices descend from it.
- Decided
- Aug 12, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983831 (1999). 6 ancestors in all. 134 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 1 generation backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- This deviceK031770 CI TKR/UkrBrainlab AG · 2003
- Descendant · cites it directly · 133 of its ownK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- Descendant · 2 generations on · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- Descendant · 3 generations on · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- Descendant · cites it directly · 54 of its ownK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- Descendant · 2 generations on · 52 of its ownK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 134 · See all- K041899Vectorvision Uni-KneeBrainlab AG · 2004 · cites it directly133descendants
- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · 2 generations on78descendants
- K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · 3 generations on76descendants
- K052966CI Knee, CI MI TKRBrainlab AG · 2006 · cites it directly54descendants
- K073615Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedBrainlab AG · 2008 · 2 generations on52descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −1 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| 0 (this device) | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| +1 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| +2 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| +3 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| +1 | 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 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 5 | 0 |
| 2022 | 11 | 0 |
| 2023 | 10 | 0 |
| 2024 | 13 | 0 |
| 2025 | 16 | 0 |
| 2026 | 11 | 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? (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 |
|---|---|---|---|
| * | K021306 | Vectorvision CT-Free KneeSummary page 1…Knee), BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Predicate Devices: BrainLAB Vector Vision@CT-free knee (K 021306) BrainLAB Kolibri'" Image Guided Surgery System (KO14256) Device Classification Name: Instrument, Stereotaxic Regulatory Class… | 2002 |
| * | K014256 | Kolibri Igs Systems | 2002 |
What descends from it? (134)
See all 1342 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 4 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K041899 (Brainlab AG, 2004) has gone furthest, with 133 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.
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?
Ci TKR/UKR 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 stereo tactic surgery may be appropriate…
Read the full statement (161 words)
Ci TKR/UKR 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 stereo tactic 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 Ci TKR/UKR.
Example orthopedic surgical procedures include but are not limited to:
Knee Procedures:
Total Knee Replacement
Unicondylar Knee Replacement
Ligament Balancing
Range of Motion Analysis
Cruciate Ligament Surgery
Patella Tracking
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031770: CI TKR/Ukr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031770
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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