510(k) · Cleared
ClearedSmith & Nephew Image Guided Surgical Instruments for Hip Applications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Sep 10, 2004 as substantially equivalent to K021798 (Smith & Nephew, Inc., 2002) after a 329-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.
- Decided
- Sep 10, 2004
- Review
- 329 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021798 (2002). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK021798 Smith & Nephew Image Guided Surgical Instruments for Hip ApplicationsSmith & Nephew, Inc. · 2002
- This deviceK033341 Smith & Nephew Image Guided Surgical Instruments for Hip ApplicationsSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK052178 Depuy Cas Hip InstrumentationDePuy Orthopaedics, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK071135 Depuy CI Hip InstrumentationDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK053348 Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp. · 2006
- Descendant · cites it directly · 0 of its ownK060121 Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments…Biomet Manufacturing Corp · 2006
Most influential descendants
Showing 4 of 4 · See all- K052178Depuy Cas Hip InstrumentationDePuy Orthopaedics, Inc. · 2005 · cites it directly2descendants
- K071135Depuy CI Hip InstrumentationDePuy Orthopaedics, Inc. · 2007 · 2 generations on0descendants
- K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp. · 2006 · cites it directly0descendants
- K060121Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsBiomet Manufacturing Corp · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021798 | Smith & Nephew Image Guided Surgical Instruments for Hip Applications | Smith & Nephew, Inc. | 2002 | — |
| 0 (this device) | K033341 | Smith & Nephew Image Guided Surgical Instruments for Hip Applications | Smith & Nephew, Inc. | 2004 | — |
| +1 | K052178 | Depuy Cas Hip Instrumentation | DePuy Orthopaedics, Inc. | 2005 | — |
| +2 | K071135 | Depuy CI Hip Instrumentation | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K053348 | Stryker Orthopaedics Rfid Instrumentation | Howmedica Osteonics Corp. | 2006 | — |
| +1 | K060121 | Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip… | Biomet Manufacturing Corp | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 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? (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 |
|---|---|---|---|
| * | K021798 | Smith & Nephew Image Guided Surgical Instruments for Hip ApplicationsSummary page 1…ked in real time in the surgical field, Smith & Nephew has previously received clearance for Image-Guided Instruments and Software for Hip Applications under K021798 for use on the Medtronic Surgical Navigation Technologies StealthStation® Platform Systems. The Smith & Nephew Image Guided… | 2002 |
| † | K022365 | Stryker Navigation System - Hip Module | 2003 |
| † | K010602 | Vectorvision Hip | 2001 |
| † | K021980 | Hip Module for the Stealthstation System | 2002 |
| † | K022364 | Navitrack System Total Hip Replacement,Model 900.200 | 2003 |
| † | K040368 | Vectorvision Hip 3.0 | 2004 |
What descends from it? (4)
3 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?
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?
Image Guided Surgical Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a Long bone can be identified relative to a CT based…
Read the full statement (121 words)
Image Guided Surgical Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a Long bone can be identified relative to a CT based model or fluoroscopic image of the anatomy or by an individual 3D-model of the patents bone, which is generated through acquiring multiple landmarks on the bone surface_ These procedures include but are not limited to, acetabutar cup placement as part of a partial or total hip arthroplasty (primary or revision).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033341: Smith & Nephew Image Guided Surgical Instruments for Hip Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033341
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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