510(k) · Cleared
ClearedSmith & Nephew Image Surgical Instruments for Trauma 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 Oct 17, 2002 after a 136-day review. The FDA summary names no predicate by number.
- Decided
- Oct 17, 2002
- Review
- 136 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
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?
Smith & Nephew Image Guided Surgical Instruments for Trauma Applications are intended to be used with the Universal Accessories to assist the surgeon in precisely locating anatomical structures in either open 01 percutaneous procedures. Image Guided Surgical Instruments for Trauma Applications are indicated for use in surgical trauma procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical…
Read the full statement (164 words)
Smith & Nephew Image Guided Surgical Instruments for Trauma Applications are intended to be used with the Universal Accessories to assist the surgeon in precisely locating anatomical structures in either open 01 percutaneous procedures. Image Guided Surgical Instruments for Trauma Applications are indicated for use in surgical trauma 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 (femur, tibia, humerus, radius, ulna, fibula): pelvic bone (including acetabular), calcaneus, and talus 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:
Spinal procedures and spinal implant procedures such as pedicle screw placement
Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation
Fracture treatment procedures, such as intramedullary nailing or plating or screwing or external fixation procedures in the tubular bones
Additional procedures include:
Fracture reduction procedures
High Tibia Osteotomy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021815: Smith & Nephew Image Surgical Instruments for Trauma Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021815
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026