510(k) · Cleared
ClearedAcustar I Advanced Surgical Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 11, 1995 after a 448-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 83 later devices descend from it.
- Decided
- Dec 11, 1995
- Review
- 448 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
83 later devices descend from it, 2 citing it directly.
- This deviceK944612 Acustar I Advanced Surgical Navigation SystemCodman & Shurtleff, Inc. · 1995
- Descendant · cites it directly · 71 of its ownK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- Descendant · 2 generations on · 66 of its ownK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- Descendant · 3 generations on · 36 of its ownK981315 NavitrackOrthosoft, Inc. · 1998
- Descendant · 4 generations on · 35 of its ownK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- Descendant · 5 generations on · 34 of its ownK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K960714Isg Viewing WandI.S.G. Technologies, Inc. · 1996 · cites it directly71descendants
- K964229Regulus NavigatorCompass Intl., Inc. · 1997 · 2 generations on66descendants
- K981315NavitrackOrthosoft, Inc. · 1998 · 3 generations on36descendants
- K033413Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004 · 4 generations on35descendants
- K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005 · 5 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944612 | Acustar I Advanced Surgical Navigation System | Codman & Shurtleff, Inc. | 1995 | — |
| +1 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| +2 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| +3 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| +4 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| +5 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 1 | 0 |
| 2020 | 12 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (83)
See all 832 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?
- Of its descendants, K960714 (I.S.G. Technologies, Inc., 1996) has gone furthest, with 71 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
https://510kreport.com/device/K944612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944612: Acustar I Advanced Surgical 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/K944612
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026