510(k) · Cleared
Recalled · Class II · 2017Smarttools Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer · OLO Orthopedic Stereotaxic Instrument
Cleared on Nov 30, 2012 as substantially equivalent to K103829 (Orthalign, Inc., 2011) after a 121-day review. Its family tree reaches back 9 generations to 1999. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 30, 2012
- Review
- 121 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K983831 (1999). 19 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations between
- 3 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 2 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 1 generation backK103829 Kneealign SystemOrthalign, Inc. · 2011
- This deviceK122326 Smarttools Knee SystemZimmer · 2012
- Descendant · cites it directly · 2 of its ownK141601 Iassist Knee SystemZimmer Cas · 2014
- Descendant · cites it directly · 1 of its ownK192080 iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · 2 generations on · 0 of its ownK213033 iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas · 2022
Show all 9 generations
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 8 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 7 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 6 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 5 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 4 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 3 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 2 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 1 generation backK103829 Kneealign SystemOrthalign, Inc. · 2011
- This deviceK122326 Smarttools Knee SystemZimmer · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −8 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −7 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −6 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −5 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −4 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −3 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −2 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −1 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| 0 (this device) | K122326 | Smarttools Knee System | Zimmer | 2012 | — |
| +1 | K141601 | Iassist Knee System | Zimmer Cas | 2014 | — |
| +1 | K192080 | iASSIST Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| +2 | K213033 | iASSIST Knee System | Orthosoft D/B/A Zimmer Cas | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K103829 | Kneealign SystemSummary page 1…Device Classification Name: Orthopedic Stereotaxic Instrument (product code OLO); 21 CFR § 882.4560 Predicate Device: KneeAlign 2 System, form OrthAlign Inc., 5 10(k) # K1 03 829 Device Description: The iASSIST Knee System consists of tracking sensors, a computer system, software, and surgical instruments… | 2011 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Feb 20, 2017 | Class II | Z-1868-2017 | Other | There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P |
| Apr 19, 2015 | Class II | Z-1701-2015 | Device Design | Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K141601 (Zimmer Cas, 2014) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K103829.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and implant components relative to these axes.
Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122326: Smarttools Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122326
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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