510(k) · Cleared
ClearedSurgetics Ortho Osteologics 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 Apr 10, 2006 as substantially equivalent to K031196 (Praxim, 2005) and 1 other predicate after a 111-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Apr 10, 2006
- Review
- 111 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010612 (2001). 7 ancestors in all, the oldest K002053 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −2 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −1 | K042513 | Vectorvision Osteotomy | Brainlab AG | 2005 | — |
| 0 (this device) | K053542 | Surgetics Ortho Osteologics Navigation System | Praxim S.A | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K031196 | Surgetics Ortho Kneelogics Navigation SystemSummary page 1…stem Classification Name: Stereotaxic Instrument: 21 CFR 882.4560, Class II 3. Predicate Device PRAXIM - Surgetics ORTHO KNEELOGICS navigation system (K 031196) BrainLab -VectorVision® Osteotomy (K 042513) PRAXIM S.A. 510(k) November 15th, 2005 CONFIDENT… | 2005 |
| * | K042513 | Vectorvision OsteotomySummary page 1…ent: 21 CFR 882.4560, Class II 3. Predicate Device PRAXIM - Surgetics ORTHO KNEELOGICS navigation system (K 031196) BrainLab -VectorVision® Osteotomy (K 042513) PRAXIM S.A. 510(k) November 15th, 2005 CONFIDENTIAL Surgetics ORTHO OSTEOLOGICS navigation system… | 2005 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K031196.
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 OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures.
Examples of orthopedic surgical procedures include, but are not limited to:
Open wedge osteotomy for the lower limb
Closed wedge osteotomy for the lower limb
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053542: Surgetics Ortho Osteologics 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/K053542
Report an extraction error
Are you the manufacturer?
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