510(k) · Cleared
ClearedDepuy CI 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 May 23, 2007 as substantially equivalent to K052178 (DePuy Orthopaedics, Inc., 2005) after a 30-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- May 23, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010612 (2001). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 3 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 2 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 1 generation backK052178 Depuy Cas Hip InstrumentationDePuy Orthopaedics, Inc. · 2005
- This deviceK071135 Depuy CI Hip InstrumentationDePuy Orthopaedics, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −3 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −2 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −1 | K052178 | Depuy Cas Hip Instrumentation | DePuy Orthopaedics, Inc. | 2005 | — |
| 0 (this device) | K071135 | Depuy CI Hip Instrumentation | DePuy Orthopaedics, Inc. | 2007 | — |
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 |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052178 | Depuy Cas Hip InstrumentationSummary page 1…instumnt DEVICE PRODUCT CODE: 84 HAW SUBSTANTIALLY EQUIVALENT DePuy CAS Hip Instrumentation, K052178 DEVICE: BrainLAB VectorVision Hip Software, K05221 DEVICE DESCRIPTION AND INTENDED USE: The… | 2005 |
| Kept off the family tree | K052218 | FDA’s K052218 is Crono Five and Crono Pca 50 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K052178.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 (123 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/K071135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071135: Depuy CI Hip Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071135
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