510(k) · Cleared

Cleared

Axon MP-1 Micropositioner

K990683510(k) TraditionalCleared Nov 3, 1999245-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Axon Instruments, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Nov 3, 1999 as substantially equivalent to K811452 (Trent Wells, Inc., 1981) after a 245-day review. Its family tree reaches back 1 generation to 1981. 1 of the 4 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Nov 3, 1999
Review: 245 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K811452 (1981). 2 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
This deviceK990683 Axon MP-1 MicropositionerAxon Instruments, Inc. · 1999
Descendant · cites it directly · 1 of its ownK011775 Micro Targeting Drive SystemFHC, Inc. · 2001 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK040979 Elekta Microdrive, Model 916716Elekta Instrument AB · 2004

Class I recalls in this family

K011775 Micro Targeting Drive Systemcites it directly · 2001

Most influential descendants

Showing 2 of 2 · See all

K011775Micro Targeting Drive SystemFHC, Inc. · 2001 · cites it directly1descendant
K040979Elekta Microdrive, Model 916716Elekta Instrument AB · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K811452	Brown-Roberts-Wells Stereotaxic Sytem	Trent Wells, Inc.	1981	—
0 (this device)	K990683	Axon MP-1 Micropositioner	Axon Instruments, Inc.	1999	—
+1	K011775	Micro Targeting Drive System	FHC, Inc.	2001	Class I
+2	K040979	Elekta Microdrive, Model 916716	Elekta Instrument AB	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	1
2004	1	0

FIG. 1 — Lineage of K990683, 1981–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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

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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	Applicant	Decided	Recalls
*	K811452	Brown-Roberts-Wells Stereotaxic Sytem Summary page 2 …er Stereotaxic Instruments and Accessories 2-2 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Radionics Brown-Roberts-Wells K811452 6/1/81 Stereotaxic System Radionics Semi-Micro-Electrode Kit Preamendment Not applicable device DEVICE DESCRIPTION The MP-1…	Trent Wells, Inc.	1981	—
*	—	Semi-Micro-Electrode Kit Named without a submission number			—

Also cleared against K811452: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K011775	Micro Targeting Drive System Class I	FHC, Inc.	2001	1

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K011775Micro Targeting Drive SystemFHC, Inc. · 2001 · Cites it directly · ◆ in the 2001 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K011775 (FHC, Inc., 2001) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K811452.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAW

9in 2025

2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007high 238 (2014) · low 66 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HAW

2in 2025

2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007high 6,062 (2019) · low 49 (2007)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?

The indications for use of the Guideline System 3000 MP-1 Micropositioner are for procedures where a precise placement of probes, such as those used for electrophysiological recording and stimulation, lesioning, or chronic stimulation within the nervous system is required.

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/K990683 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990683: Axon MP-1 Micropositioner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990683

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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