510(k) · Cleared
ClearedSurgetics Ortho Kneelogics Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Praxim · HAW Neurological Stereotaxic Instrument
Cleared on Jun 7, 2005 as substantially equivalent to K021306 (Brainlab AG, 2002) and 1 other predicate after a 783-day review. Its family tree reaches back 2 generations to 2000. 149 later devices descend from it.
- Decided
- Jun 7, 2005
- Review
- 783 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002053 (2000). 5 ancestors in all. 149 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 1 generation backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- This deviceK031196 Surgetics Ortho Kneelogics Navigation SystemPraxim · 2005
- Descendant · cites it directly · 147 of its ownK060282 Total Knee Surgetics Navigation SystemPraxim S.A · 2006
- Descendant · cites it directly · 99 of its ownK062146 Uni Knee Surgetics Navigation SystemPraxim S.A · 2006
- Descendant · 2 generations on · 79 of its ownK071714 Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- Descendant · 3 generations on · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
Showing 5 of 149 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 149 · See all- K060282Total Knee Surgetics Navigation SystemPraxim S.A · 2006 · cites it directly147descendants
- K062146Uni Knee Surgetics Navigation SystemPraxim S.A · 2006 · cites it directly99descendants
- K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc. · 2007 · 2 generations on79descendants
- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · 2 generations on78descendants
- K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · 3 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −1 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| 0 (this device) | K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim | 2005 | — |
| +1 | K060282 | Total Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| +1 | K062146 | Uni Knee Surgetics Navigation System | Praxim S.A | 2006 | — |
| +2 | K071714 | Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003 | Orthosoft, Inc. | 2007 | 2 |
| +2 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| +3 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 15 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 13 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 16 | 0 |
| 2024 | 14 | 0 |
| 2025 | 16 | 0 |
| 2026 | 11 | 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? (2)
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 |
|---|---|---|---|
| * | K021306 | Vectorvision CT-Free KneeSummary page 1…ided surgical navigation system Classification Name: Computed tomography x-ray system (accessory) 3. Predicate Device BrainLab Vector Vision CT-Free (K021306) OrthoSoft Navitrack System-Optical TKR CT-Less (K021760) 4. Intended Use The Surgetics ORTHO KNEELOGICS Navi… | 2002 |
| * | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120Summary page 1…uted tomography x-ray system (accessory) 3. Predicate Device BrainLab Vector Vision CT-Free (K021306) OrthoSoft Navitrack System-Optical TKR CT-Less (K021760) 4. Intended Use The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic sur… | 2002 |
What descends from it? (149)
See all 1493 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 5 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K060282 (Praxim S.A, 2006) has gone furthest, with 147 descendants of its own.
- 9 other devices also cite its predicate K021306.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:
* Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of potential insertion points based on a digitized anatomical model
* Total Knee Arthroplasty with ZIMMER NEXGEN implant
* UniKnee Arthroplasty with BIOMET OXFORD Phase III implant
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031196: Surgetics Ortho Kneelogics Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031196
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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