510(k) · Cleared
ClearedApolloKnee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin U.S.A. Limited · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 26, 2023 as substantially equivalent to K200888 (Corin, Ltd., 2020) after a 92-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Jul 26, 2023
- Review
- 92 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K002053 (2000). 34 ancestors in all, the oldest K983831 (1999). No later device cites it as a predicate yet.
- Root · 10 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 6 generations between
- 3 generations backK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- 2 generations backK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
- 1 generation backK200888 OMNIBotics Knee SystemCorin, Ltd. · 2020
- This deviceK231172 ApolloKneeCorin U.S.A. Limited · 2023
Show all 10 generations
- Root · 10 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 9 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 8 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 7 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 6 generations backK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- 5 generations backK063408 Ctlogics Navigations SystemsPraxim Medivision, SA · 2007
- 4 generations backK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
- 3 generations backK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- 2 generations backK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
- 1 generation backK200888 OMNIBotics Knee SystemCorin, Ltd. · 2020
- This deviceK231172 ApolloKneeCorin U.S.A. Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −9 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −8 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −7 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −6 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −5 | K063408 | Ctlogics Navigations Systems | Praxim Medivision, SA | 2007 | — |
| −4 | K081232 | Total Knee Surgetics Navigation System with Praxiteles | Praxim | 2008 | — |
| −3 | K090953 | Total Knee Surgetics Navigation System with Iblock | Praxim Medivision, SA | 2010 | 2 |
| −2 | K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017 | — |
| −1 | K200888 | OMNIBotics Knee System | Corin, Ltd. | 2020 | — |
| 0 (this device) | K231172 | ApolloKnee | Corin U.S.A. Limited | 2023 | — |
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 |
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 |
|---|---|---|---|
| * | K200888 | OMNIBotics Knee SystemSummary page 4…21 CFR 882.4560 Classification Panel: Orthopedic Product Codes: OLO – Class II Primary Predicate Device: • OMNIBotics Knee System (K200888) Device Description: ApolloKnee™ (formerly OMNIBotics) is a robotic-assisted stereotaxic surgery system that aids the surgeon i… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 34 ancestors have a recall of any class.
- 1 other device also cites its predicate K200888.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
ApolloKnee is indicated to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee arthroplasty.
Apollo Robot and BalanceBot are optional accessories and are specifically indicated for use in total knee arthroplasty with the ApolloKnee system.
ApolloKnee is compatible with the following implant systems:
• Apex Knee™ System.
• Unity Knee™ System.
ApolloKnee is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231172: ApolloKnee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231172
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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