510(k) · Cleared
ClearedTotal Knee Surgetics Navigation System with Praxiteles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Praxim · HAW Neurological Stereotaxic Instrument
Cleared on Aug 6, 2008 as substantially equivalent to K060282 (Praxim S.A, 2006) and 2 other predicates after a 97-day review. Its family tree reaches back 6 generations to 2000. 18 later devices descend from it.
- Decided
- Aug 6, 2008
- Review
- 97 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K002053 (2000). 24 ancestors in all, the oldest K983831 (1999). 18 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 5 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 4 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 3 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 2 generations backK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- 1 generation backK063408 Ctlogics Navigations SystemsPraxim Medivision, SA · 2007
- This deviceK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
- Descendant · cites it directly · 17 of its ownK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- Descendant · 2 generations on · 12 of its ownK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
- Descendant · 3 generations on · 11 of its ownK200888 OMNIBotics Knee SystemCorin, Ltd. · 2020
- Descendant · 4 generations on · 9 of its ownK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- Descendant · 5 generations on · 4 of its ownK231963 Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · cites it directly17descendants
- K163338OMNIBotics Knee SystemOmnllife Science, Inc. · 2017 · 2 generations on12descendants
- K200888OMNIBotics Knee SystemCorin, Ltd. · 2020 · 3 generations on11descendants
- K221224Real Intelligence CoriBlue Belt Technologies, Inc. · 2022 · 4 generations on9descendants
- K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −5 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −4 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −3 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −2 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −1 | K063408 | Ctlogics Navigations Systems | Praxim Medivision, SA | 2007 | — |
| 0 (this device) | K081232 | Total Knee Surgetics Navigation System with Praxiteles | Praxim | 2008 | — |
| +1 | K090953 | Total Knee Surgetics Navigation System with Iblock | Praxim Medivision, SA | 2010 | 2 |
| +2 | K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017 | — |
| +3 | K200888 | OMNIBotics Knee System | Corin, Ltd. | 2020 | — |
| +4 | K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| +5 | K231963 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | 2023 | 2 |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K060282 | Total Knee Surgetics Navigation SystemSummary page 1…Name: Image guided surgical navigation system Classification Name: Computed tomography x-ray system (accessory) 2. Equivalent to: 510(k) number K060282 K061362 K063408 Proprietary Name PRAXIM PLUS PRAXIMN… | 2006 |
| * | K061362 | Pigalileo Total Knee Replacement (TKR) SystemSummary page 1…rgical navigation system Classification Name: Computed tomography x-ray system (accessory) 2. Equivalent to: 510(k) number K060282 K061362 K063408 Proprietary Name PRAXIM PLUS PRAXIMN… | 2006 |
| * | K063408 | Ctlogics Navigations SystemsSummary page 1…system Classification Name: Computed tomography x-ray system (accessory) 2. Equivalent to: 510(k) number K060282 K061362 K063408 Proprietary Name PRAXIM PLUS PRAXIMN ORTHOPED… | 2007 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090953 | Total Knee Surgetics Navigation System with Iblock | 2010 | 17 |
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 8 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 24 ancestors have a recall of any class.
- Of its descendants, K090953 (Praxim Medivision, SA, 2010) has gone furthest, with 17 descendants of its own.
- 5 other devices also cite its predicate K060282.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The TOTAL KNEE SURGETICS Navigation System with Praxiteles 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/K081232 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081232: Total Knee Surgetics Navigation System with Praxiteles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081232
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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