510(k) · Cleared
ClearedCtlogics Navigations Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Praxim Medivision, SA · HAW Neurological Stereotaxic Instrument
Cleared on Feb 28, 2007 as substantially equivalent to K053159 (Brainlab AG, 2006) and 2 other predicates after a 107-day review. Its family tree reaches back 5 generations to 2000. 34 later devices descend from it.
- Decided
- Feb 28, 2007
- Review
- 107 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K002053 (2000). 17 ancestors in all, the oldest K983831 (1999). 34 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 4 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 3 generations backK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- 2 generations backK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- 1 generation backK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- This deviceK063408 Ctlogics Navigations SystemsPraxim Medivision, SA · 2007
- Descendant · cites it directly · 18 of its ownK081232 Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008
- Descendant · 2 generations on · 17 of its ownK090953 Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · Recalled
- Descendant · cites it directly · 15 of its ownK162567 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017 · Recalled
- Descendant · 2 generations on · 14 of its ownK173372 ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · Recalled
- Descendant · 3 generations on · 12 of its ownK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K081232Total Knee Surgetics Navigation System with PraxitelesPraxim · 2008 · cites it directly18descendants
- K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA · 2010 · 2 generations on17descendants
- K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2017 · cites it directly15descendants
- K173372ExactechGPS Total Shoulder ApplicationBlue Ortho · 2017 · 2 generations on14descendants
- K163338OMNIBotics Knee SystemOmnllife Science, Inc. · 2017 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −4 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −3 | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| −2 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| −1 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| 0 (this device) | K063408 | Ctlogics Navigations Systems | Praxim Medivision, SA | 2007 | — |
| +1 | 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 | K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2017 | 1 |
| +2 | K173372 | ExactechGPS Total Shoulder Application | Blue Ortho | 2017 | 1 |
| +3 | K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K053159 | Vectorvision SpineSummary page 1…Common/Usual Name: Image guided surgical navigation system Classification Name: Computed tomography x-ray system (accessory) .3. Equivalent to: K053 159 - VectorVision spine - BrainLAB AG K062 146 - UNI KNEE SURGETICS Navigation System - PRAXIM S.A. K022239 - Surget… | 2006 |
| * | K062146 | Uni Knee Surgetics Navigation SystemSummary page 1…on system Classification Name: Computed tomography x-ray system (accessory) .3. Equivalent to: K053 159 - VectorVision spine - BrainLAB AG K062 146 - UNI KNEE SURGETICS Navigation System - PRAXIM S.A. K022239 - Surgetics ENTact Endonasal Navigation System - PRAXIM S.A.… | 2006 |
| * | K022239 | Surgetics Entact Endonasal Navigation SystemSummary page 1…m (accessory) .3. Equivalent to: K053 159 - VectorVision spine - BrainLAB AG K062 146 - UNI KNEE SURGETICS Navigation System - PRAXIM S.A. K022239 - Surgetics ENTact Endonasal Navigation System - PRAXIM S.A. 41. Intended Use: The CTLOGICS Navigation System is an… | 2002 |
What descends from it? (34)
See all 342 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 7 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K081232 (Praxim, 2008) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K053159.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 CTLOGICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures. The system which uses patient's preoperative image data is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone, or a vertebra can be…
Read the full statement (127 words)
The CTLOGICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures.
The system which uses patient's preoperative image data is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone, or a vertebra can be identified relative to CT-based model of the anatomical structure.
Example procedures include but are not limited to:
Posterior spinal implant procedures such as pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine surgery, tumor surgery on the spinal column.
Superolateral and deltopectoral shoulder procedures, such as guiding the glenoid component on the scapula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063408: Ctlogics Navigations Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063408
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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