510(k) · Cleared
ClearedDepuy Cas Hip 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 Oct 21, 2005 as substantially equivalent to K040368 (Brainlab AG, 2004) and 3 other predicates after a 72-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 21, 2005
- Review
- 72 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K010612 (2001). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 2 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 1 generation backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- This deviceK052178 Depuy Cas Hip InstrumentationDePuy Orthopaedics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK071135 Depuy CI Hip InstrumentationDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK060121 Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments…Biomet Manufacturing Corp · 2006
Most influential descendants
Showing 2 of 2 · See allView 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 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| 0 (this device) | K052178 | Depuy Cas Hip Instrumentation | DePuy Orthopaedics, Inc. | 2005 | — |
| +1 | K071135 | Depuy CI Hip Instrumentation | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K060121 | Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip… | Biomet Manufacturing Corp | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K040368 | Vectorvision Hip 3.0Summary page 1…ulatory Classification: 882.4560; Stereotaxic Instrument; Class II Device Product Code: HAW Substantially Equivalent Device: *K040368 VectorVision Hip -K033223 Zimmer Ortho Guidance Systems -… | 2004 |
| * | K033223 | Zimmer Ortho Guidance Systems- Hip InstrumentsSummary page 1…nt; Class II Device Product Code: HAW Substantially Equivalent Device: *K040368 VectorVision Hip -K033223 Zimmer Ortho Guidance Systems - Hip Instruments… | 2004 |
| * | K033341 | Smith & Nephew Image Guided Surgical Instruments for Hip ApplicationsSummary page 1…-K033223 Zimmer Ortho Guidance Systems - Hip Instruments *K033341 Smith & Nephew Image-Guided Surgical Instruments for Hip Applications… | 2004 |
| * | K021798 | Smith & Nephew Image Guided Surgical Instruments for Hip ApplicationsSummary page 1…*K033341 Smith & Nephew Image-Guided Surgical Instruments for Hip Applications *K021798 Image Guided Surgical Instruments for Hip Applications Device Description and Intend… | 2002 |
What descends from it? (2)
2 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 4 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K071135 (DePuy Orthopaedics, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K040368.
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 preparation during intraoperative hip reconstructive procedures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be…
Read the full statement (120 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 preparation during intraoperative hip 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 Joint Replacement (TJR)
*Revision Surgery of TJR
*Tumor resection and Bone/Joint Reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052178: Depuy Cas Hip Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052178
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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