510(k) · Cleared
ClearedZimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Dec 28, 2005 as substantially equivalent to K033011 (Zimmer, Inc., 2004) after a 117-day review. Its family tree reaches back 2 generations to 2003. 5 of the 133 devices in its family, counting itself, have a Class I recall. 130 later devices descend from it.
- Decided
- Dec 28, 2005
- Review
- 117 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022126 (2003). 130 later devices descend from it, 2 citing it directly. 5 of the 133 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK022126 Catheter Introducer for the Stealthstation SystemMedtronic Surgical Navigation Technologies · 2003
- 1 generation backK033011 Zimmer Ortho Guidance Systems- Knee InstrumentsZimmer, Inc. · 2004
- This deviceK052425 Zimmer Computer Assisted Solutions-Electromagnetic and Imageless…Zimmer, Inc. · 2005
- Descendant · cites it directly · 128 of its ownK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- Descendant · 2 generations on · 127 of its ownK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- Descendant · 3 generations on · 126 of its ownK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- Descendant · 4 generations on · 109 of its ownK151511 ROSA SpineMedtech S.A · 2016 · Recalled
- Descendant · 5 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 130 · See all- K060556Brigit Surgical DeviceZimmer, Inc. · 2006 · cites it directly128descendants
- K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · 2 generations on127descendants
- K101791Rosa Surgical DeviceMedtech S.A.S · 2010 · 3 generations on126descendants
- K151511ROSA SpineMedtech S.A · 2016 · 4 generations on109descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 5 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022126 | Catheter Introducer for the Stealthstation System | Medtronic Surgical Navigation Technologies | 2003 | — |
| −1 | K033011 | Zimmer Ortho Guidance Systems- Knee Instruments | Zimmer, Inc. | 2004 | — |
| 0 (this device) | K052425 | Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee… | Zimmer, Inc. | 2005 | — |
| +1 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| +2 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| +3 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| +4 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
| +5 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 1 |
| 2019 | 9 | 1 |
| 2020 | 2 | 1 |
| 2021 | 8 | 1 |
| 2022 | 11 | 0 |
| 2023 | 19 | 0 |
| 2024 | 20 | 0 |
| 2025 | 27 | 0 |
| 2026 | 24 | 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.
5 devices in this family have a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K033011 | Zimmer Ortho Guidance Systems- Knee InstrumentsSummary page 1…Zimnier Ortho Guidance Systemrs - Knee Instruments, manufactured by Zimmer, Inc., K03301 1, cleared February 12, 2004. Device Description: This submission is for: *… | 2004 |
What descends from it? (130)
See all 1302 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K151359ROSA BrainMedtech S.A · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K200511ROSA ONE Brain applicationMedtech S.A · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K060556 (Zimmer, Inc., 2006) has gone furthest, with 128 descendants of its own.
- 2 other devices also cite its predicate K033011.
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?
Zimmer Knee Computer Assisted Solutions Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty (Primary and Revision)
Minimally Invasive Knee Orthopedic Procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052425: Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052425
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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