510(k) · Cleared
ClearedOMNIBotics Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnllife Science, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Sep 1, 2017 as substantially equivalent to K090953 (Praxim Medivision, SA, 2010) and 2 other predicates after a 277-day review. Its family tree reaches back 8 generations to 2000. 12 later devices descend from it.
- Decided
- Sep 1, 2017
- Review
- 277 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K002053 (2000). 32 ancestors in all, the oldest K983831 (1999). 12 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 7 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 6 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 5 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 4 generations backK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- 3 generations backK063408 Ctlogics Navigations SystemsPraxim Medivision, SA · 2007
- 2 generations backK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
- 1 generation backK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- This deviceK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
- Descendant · cites it directly · 11 of its ownK200888 OMNIBotics Knee SystemCorin, Ltd. · 2020
- Descendant · 2 generations on · 9 of its ownK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- Descendant · 3 generations on · 4 of its ownK231963 Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · Recalled
- Descendant · 4 generations on · 3 of its ownK240139 Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · Recalled
- Descendant · 3 generations on · 2 of its ownK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K200888OMNIBotics Knee SystemCorin, Ltd. · 2020 · cites it directly11descendants
- K221224Real Intelligence CoriBlue Belt Technologies, Inc. · 2022 · 2 generations on9descendants
- K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · 3 generations on4descendants
- K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · 4 generations on3descendants
- K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −7 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −6 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −5 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −4 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −3 | K063408 | Ctlogics Navigations Systems | Praxim Medivision, SA | 2007 | — |
| −2 | K081232 | Total Knee Surgetics Navigation System with Praxiteles | Praxim | 2008 | — |
| −1 | K090953 | Total Knee Surgetics Navigation System with Iblock | Praxim Medivision, SA | 2010 | 2 |
| 0 (this device) | K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017 | — |
| +1 | K200888 | OMNIBotics Knee System | Corin, Ltd. | 2020 | — |
| +2 | K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| +3 | K231963 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | 2023 | 2 |
| +4 | K240139 | Real Intelligence™ CORI™ | Blue Belt Technologies, Inc. | 2024 | 1 |
| +3 | K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024 | — |
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 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K090953 | Total Knee Surgetics Navigation System with IblockSummary page 4…cs® Knee System Classification Name: Orthopedic Stereotaxic Instrument Product Code: OLO Regulation: 21 CFR 882.4560 Substantial equivalence claimed to: K090953: TOTAL KNEE SURGETICS Navigation System with IBlock® (Primary Predicate) K150372: VERASENSE Knee System K132104: eLibra® Soft Tis… | 2010 |
| * | K150372 | VERASENSE Knee SystemSummary page 4…de: OLO Regulation: 21 CFR 882.4560 Substantial equivalence claimed to: K090953: TOTAL KNEE SURGETICS Navigation System with IBlock® (Primary Predicate) K150372: VERASENSE Knee System K132104: eLibra® Soft Tissue Force Sensor Description: The OMNIBotics® Knee system is a computer-assisted… | 2016 |
| * | K132104 | Elibra Soft-Tissue Force SensorSummary page 4…21 CFR 882.4560 Substantial equivalence claimed to: K090953: TOTAL KNEE SURGETICS Navigation System with IBlock® (Primary Predicate) K150372: VERASENSE Knee System K132104: eLibra® Soft Tissue Force Sensor Description: The OMNIBotics® Knee system is a computer-assisted navigation system with a motor… | 2014 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200888 | OMNIBotics Knee System | 2020 | 11 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 32 ancestors have a recall of any class.
- Of its descendants, K200888 (Corin, Ltd., 2020) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K090953.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 OMNIBotics® Knee System is indicated for stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The Active Spacer is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics® Knee System supports OMNI Apex Knee™ System implants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163338: OMNIBotics 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/K163338
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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