510(k) · Cleared
ClearedSmith & Nephew Image Guided Surgical Instruments for Knee 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 Feb 8, 2002 after a 161-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 8, 2002
- Review
- 161 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK012938 Smith & Nephew Image Guided Surgical Instruments for Knee ApplicationsSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK022460 Smith & Nephew Image Guided Surgical System for Knee ApplicationsSmith & Nephew, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K022460Smith & Nephew Image Guided Surgical System for Knee ApplicationsSmith & Nephew, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012938 | Smith & Nephew Image Guided Surgical Instruments for Knee Applications | Smith & Nephew, Inc. | 2002 | — |
| +1 | K022460 | Smith & Nephew Image Guided Surgical System for Knee Applications | Smith & Nephew, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (7)
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 |
|---|---|---|---|
| * | — | Kinamed Ortho Pilot Named without a submission number | |
| * | — | Surgical Navigation Technologies StealthStation Named without a submission number | |
| * | — | Surgical Navigation Technologies StealthStation™ System Passive Instrument Option Named without a submission number | |
| * | — | Surgical Navigation Technologies StealthStation™ System -ENT Application Addendum Named without a submission number | |
| * | — | Surgical Navigation Technologies StealthStation® FluoroNav™ Module Named without a submission number | |
| * | — | Surgical Navigation Technologies Indications Modifications for the StealthStation System Named without a submission number | |
| * | — | Surgical Navigation Technologies StealthStation Generation 3 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 |
|---|---|---|---|
| K022460 | Smith & Nephew Image Guided Surgical System for Knee Applications | 2002 | 0 |
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?
- Of its descendants, K022460 (Smith & Nephew, Inc., 2002) has gone furthest, with 0 descendants of its own.
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 Knee Applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are indicated for any medical condition of the knee in which the use of stereotactic 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 or fluoroscopy images of the anatomy.
Example procedures include, but are not limited to:
Orthopedic Procedures:
Primary Total Knee Arthroplasty
Revison Total Knee Arthroplasty
Unicompartmental Knee Replacement
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012938 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012938: Smith & Nephew Image Guided Surgical Instruments for Knee Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012938
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026