510(k) · Cleared
Recalled · Class II · 2020Depuy Cas Knee Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Mar 4, 2005 as substantially equivalent to K031337 (Biomet, Inc., 2003) and 1 other predicate after a 102-day review. Its family tree reaches back 7 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 4, 2005
- Review
- 102 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K905070 (1991). 18 ancestors in all, the oldest K861692 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 6 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 5 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 4 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 3 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 2 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 1 generation backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- This deviceK043223 Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK053348 Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −6 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −5 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −4 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −3 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −2 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −1 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| 0 (this device) | K043223 | Depuy Cas Knee Instrumentation | DePuy Orthopaedics, Inc. | 2005 | — |
| +1 | K053348 | Stryker Orthopaedics Rfid Instrumentation | Howmedica Osteonics Corp. | 2006 | — |
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 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K031337 | Acumen Surgical Navigation SystemSummary page 1…; Class II Device Product Code: HAW Substantially Equivalent Device: .* VectorVision CT-Free Knee *K031337 Acumen Surgical Navigation System *K033011 Zimmer… | 2003 |
| * | K033011 | Zimmer Ortho Guidance Systems- Knee InstrumentsSummary page 1…e Knee *K031337 Acumen Surgical Navigation System *K033011 Zimmer Ortho Guidance Systems- Knee Instruments Device Description and Intended Use: De… | 2004 |
| * | — | VectorVision CT-Free Knee Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053348 | Stryker Orthopaedics Rfid Instrumentation | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2020 | Class II | Z-1169-2020 | Process control | The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K053348 (Howmedica Osteonics Corp., 2006) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031337.
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?
Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for precise bone cuts during minimally invasive intraoperative knee reconstructive procedures. The system is indicated for any medical condition in which the use of stereotaxic…
Read the full statement (126 words)
Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for precise bone cuts during minimally invasive intraoperative knee reconstructive procedures. The system is indicated for any 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 of the anatomy.
Example orthopaedic procedures for these instruments include, but are not limited to:
*Total Knee Replacement
*Unicondylar Knee Replacement
*Ligament Balancing
-Range of Motion Analysis
*Cruciate Ligament Surgery
-Patella Tracking
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043223: Depuy Cas 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/K043223
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