510(k) · Cleared
ClearedAcumen Surgical Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jul 8, 2004 as substantially equivalent to K023975 (Z-Kat, Inc., 2002) and 1 other predicate after a 428-day review. Its family tree reaches back 6 generations to 1991. 146 later devices descend from it.
- Decided
- Jul 8, 2004
- Review
- 428 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K905070 (1991). 15 ancestors in all, the oldest K861692 (1986). 146 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 5 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 4 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 3 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 2 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 1 generation backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- This deviceK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- Descendant · cites it directly · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- Descendant · cites it directly · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- Descendant · cites it directly · 71 of its ownK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- Descendant · 2 generations on · 46 of its ownK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- Descendant · 3 generations on · 44 of its ownK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
Showing 5 of 146 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 146 · See all- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · cites it directly78descendants
- K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · cites it directly76descendants
- K111863Signature Planner,Signature GuidesMaterialise NV · 2012 · cites it directly71descendants
- K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · 2 generations on46descendants
- K143752Total Knee Application (TKA)Mako Surgical Corp. · 2015 · 3 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −5 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −4 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −3 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −2 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −1 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| 0 (this device) | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| +1 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| +1 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| +1 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| +2 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| +3 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 11 | 0 |
| 2018 | 2 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 9 | 0 |
| 2022 | 14 | 0 |
| 2023 | 20 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 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 |
|---|---|---|---|
| * | K023975 | Voyager LinuxSummary page 1…rument (21 CFR 882.4560) Device Classification: Class II Legally Marketed Devices to Which Substantial Equivalence is claimed: Voyager TM Linux (K023975) FluroLab® Plus (K(013025) Device Description: The Acumen TM Surgical Navigation System includes gener… | 2002 |
| * | K013025 | Modification to Flourolab PlusSummary page 1…Class II Legally Marketed Devices to Which Substantial Equivalence is claimed: Voyager TM Linux (K023975) FluroLab® Plus (K(013025) Device Description: The Acumen TM Surgical Navigation System includes general instrumentation that is utilized with applicati… | 2001 |
What descends from it? (146)
See all 1463 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 13 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K072806 (Mako Surgical Corp., 2008) has gone furthest, with 78 descendants of its own.
- 4 other devices also cite its predicate K023975.
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 Acumen TM Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen TM System is indicated for use in surgical knee and hip procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures, can be identified relative to fluoroscopy (hip procedures) or an imageless model of the anatomy (knee procedures). These procedures include, but are not limited to, knee and hip arthroplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031454: Acumen 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/K031454
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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