510(k) · Cleared
ClearedMayfield Acciss II Image Guided Surgery System, Model 2002-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schaerer Mayfield USA, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jun 1, 2005 as substantially equivalent to K013428 (Ohio Medical Instrument Co., Inc., 2002) and 1 other predicate after a 322-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jun 1, 2005
- Review
- 322 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954276 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK954276 StealthstationSurgical Navigation Technologies, Inc. · 1996 · Recalled
- 2 generations backK981686 Stealthstation System Digitizer ChangeSurgical Navigation Technologies, Inc. · 1998
- 1 generation backK013428 Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss…Ohio Medical Instrument Co., Inc. · 2002
- This deviceK041897 Mayfield Acciss II Image Guided Surgery System, Model 2002-01Schaerer Mayfield USA, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954276 | Stealthstation | Surgical Navigation Technologies, Inc. | 1996 | 1 |
| −2 | K981686 | Stealthstation System Digitizer Change | Surgical Navigation Technologies, Inc. | 1998 | — |
| −1 | K013428 | Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss System | Ohio Medical Instrument Co., Inc. | 2002 | — |
| 0 (this device) | K041897 | Mayfield Acciss II Image Guided Surgery System, Model 2002-01 | Schaerer Mayfield USA, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013428 | Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss System | 2002 |
| * | K013419 | Nicolet Electromagnetic Navigation SystemSummary page 1…System Mvayfield® ACCLSSTM Operating Arm System and Mayfield®~ Optical ACCLSS (KO 13428) Nicolet Biomedical Electromagnetic Navigational System (K013419) 3. Classification: Neurosurgical stereotactic instruments and accessories are Class 11 (21 CER 882.4800). 4. Performance Stan… | 2001 |
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 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
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?
MAYFIELD® ACCISSTM II IMAGE GUIDED SURGERY SYSTEM is indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure such as the skull, a long bone, or vertebra can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041897: Mayfield Acciss II Image Guided Surgery System, Model 2002-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041897
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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