510(k) · Cleared
Recalled · Class II · 2019Total Knee Surgetics Navigation System with Iblock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Praxim Medivision, SA · OLO Orthopedic Stereotaxic Instrument
Cleared on Jan 21, 2010 as substantially equivalent to K081232 (Praxim, 2008) after a 293-day review. Its family tree reaches back 7 generations to 2000. 17 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 21, 2010
- Review
- 293 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K002053 (2000). 25 ancestors in all, the oldest K983831 (1999). 17 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 6 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 5 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 4 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 3 generations backK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- 2 generations backK063408 Ctlogics Navigations SystemsPraxim Medivision, SA · 2007
- 1 generation backK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
- This deviceK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010
- Descendant · cites it directly · 12 of its ownK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK200888 OMNIBotics Knee SystemCorin, Ltd. · 2020
- Descendant · 3 generations on · 9 of its ownK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- Descendant · 4 generations on · 4 of its ownK231963 Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · Recalled
- Descendant · 5 generations on · 3 of its ownK240139 Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K163338OMNIBotics Knee SystemOmnllife Science, Inc. · 2017 · cites it directly12descendants
- K200888OMNIBotics Knee SystemCorin, Ltd. · 2020 · 2 generations on11descendants
- K221224Real Intelligence CoriBlue Belt Technologies, Inc. · 2022 · 3 generations on9descendants
- K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · 4 generations on4descendants
- K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −6 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −5 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −4 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −3 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −2 | K063408 | Ctlogics Navigations Systems | Praxim Medivision, SA | 2007 | — |
| −1 | K081232 | Total Knee Surgetics Navigation System with Praxiteles | Praxim | 2008 | — |
| 0 (this device) | K090953 | Total Knee Surgetics Navigation System with Iblock | Praxim Medivision, SA | 2010 | — |
| +1 | K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017 | — |
| +2 | K200888 | OMNIBotics Knee System | Corin, Ltd. | 2020 | — |
| +3 | K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| +4 | K231963 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | 2023 | 2 |
| +5 | K240139 | Real Intelligence™ CORI™ | Blue Belt Technologies, Inc. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K081232 | Total Knee Surgetics Navigation System with PraxitelesSummary page 2…for reference and registration * TOTAL KNEE SURGETICS software application with ifflack option The main modification to the predicate device K08 1232 concerns the modification of the motorized cutting block PRAXITELES®D. 6. Technological Characteristics and S… | 2008 |
What descends from it? (17)
See all 172 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 |
|---|---|---|---|---|
| Apr 12, 2019 | Class II | Z-1717-2019 | Under Investigation by firm | The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use. |
| Oct 14, 2016 | Class III | Z-0610-2017 | Error in labeling | Incorrect lot number on outer kit |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K163338 (Omnllife Science, Inc., 2017) has gone furthest, with 12 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 TOTAL KNEE SURGETICS Navigation System with iBlock is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
It is specifically indicated for:
Total Knee Arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090953: Total Knee Surgetics Navigation System with Iblock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090953
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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