510(k) · Cleared
ClearedOMNIBotics Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin, Ltd. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 27, 2020 as substantially equivalent to K163338 (Omnllife Science, Inc., 2017) after an 85-day review. Its family tree reaches back 9 generations to 2000. 11 later devices descend from it.
- Decided
- Jun 27, 2020
- Review
- 85 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K002053 (2000). 33 ancestors in all, the oldest K983831 (1999). 11 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 5 generations between
- 3 generations backK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
- 2 generations backK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- 1 generation backK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
- This deviceK200888 OMNIBotics Knee SystemCorin, Ltd. · 2020
- Descendant · cites it directly · 9 of its ownK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK231963 Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · Recalled
- Descendant · 3 generations on · 3 of its ownK240139 Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 2 of its ownK240113 CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 8 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 7 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 6 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 5 generations backK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- 4 generations backK063408 Ctlogics Navigations SystemsPraxim Medivision, SA · 2007
- 3 generations backK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
- 2 generations backK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- 1 generation backK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
- This deviceK200888 OMNIBotics Knee SystemCorin, Ltd. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K221224Real Intelligence CoriBlue Belt Technologies, Inc. · 2022 · cites it directly9descendants
- K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · 2 generations on4descendants
- K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · 3 generations on3descendants
- K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. · 2024 · 2 generations on2descendants
- K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −8 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −7 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −6 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −5 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −4 | K063408 | Ctlogics Navigations Systems | Praxim Medivision, SA | 2007 | — |
| −3 | K081232 | Total Knee Surgetics Navigation System with Praxiteles | Praxim | 2008 | — |
| −2 | K090953 | Total Knee Surgetics Navigation System with Iblock | Praxim Medivision, SA | 2010 | 2 |
| −1 | K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017 | — |
| 0 (this device) | K200888 | OMNIBotics Knee System | Corin, Ltd. | 2020 | — |
| +1 | K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| +2 | K231963 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | 2023 | 2 |
| +3 | K240139 | Real Intelligence™ CORI™ | Blue Belt Technologies, Inc. | 2024 | 1 |
| +2 | K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | 2024 | — |
| +3 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K163338 | OMNIBotics Knee SystemSummary page 4…taxic instrument Classification Code: OLO – Class II Classification Panel: Orthopedic Regulation Number: 21 CFR 882.4560 C1. PRIMARY PREDICATE DEVICE K163338 OMNIlife Science Inc., OMNIBotics® Knee System C2. REFERENCE DEVICE K113060, K173884 Corin Ltd. Unity… | 2017 |
| † | K113060 | Unity Toatal Knee System | 2012 |
| † | K173884 | Unity Total Knee System | 2018 |
| † | K170808 | Unity Total Knee System | 2017 |
| † | K183533 | Unity Total Knee System | 2019 |
What descends from it? (11)
See all 112 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 20 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 33 ancestors have a recall of any class.
- Of its descendants, K221224 (Blue Belt Technologies, Inc., 2022) has gone furthest, with 9 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. 2020, 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 BalanceBot™ 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™ implants and CORIN Unity Knee™ implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200888 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200888: OMNIBotics Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200888
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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