510(k) · Cleared
ClearedTotal Hip Surgetics Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Praxim S.A · HAW Neurological Stereotaxic Instrument
Cleared on Dec 10, 2007 as substantially equivalent to K060468 (Brainlab AG, 2006) and 1 other predicate after a 117-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Dec 10, 2007
- Review
- 117 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010612 (2001). 15 ancestors in all, the oldest K983831 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 4 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 3 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 2 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 1 generation backK060468 Vectorvision HipBrainlab AG · 2006
- This deviceK072267 Total Hip Surgetics Navigation SystemPraxim S.A · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −4 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −3 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −2 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −1 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| 0 (this device) | K072267 | Total Hip Surgetics Navigation System | Praxim S.A | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 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 |
|---|---|---|---|
| * | K060468 | Vectorvision HipSummary page 1…Common/Usual Name: Image guided surgical navigation system Classification Name: Computed tomography x-ray system (accessory) 3. Equivalent to: K060468 - VectorVision Hip - BrainLAB AG K060282 - TOTAL KNEE SURGETICS Navigation System - PRAXIM S.A. 4. Intended Use:… | 2006 |
| * | K060282 | Total Knee Surgetics Navigation SystemSummary page 1…navigation system Classification Name: Computed tomography x-ray system (accessory) 3. Equivalent to: K060468 - VectorVision Hip - BrainLAB AG K060282 - TOTAL KNEE SURGETICS Navigation System - PRAXIM S.A. 4. Intended Use: The TOTAL HIP SURGETICS Navigation System is… | 2006 |
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 6 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 2 other devices also cite its predicate K060468.
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 TOTAL HIP SURGETICS 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 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 pelvis, the femur can be identified by acquiring multiple landmarks.
Example procedures include but are not limited to:
Hip arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072267: Total Hip Surgetics 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/K072267
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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