510(k) · Cleared

Cleared

Lapdoc I

K061224510(k) TraditionalCleared Sep 5, 2006127-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

Robodent GmbH · HAW Neurological Stereotaxic Instrument

Cleared on Sep 5, 2006 as substantially equivalent to K023424 (Denx Advanced Dental Systems, 2003) and 3 other predicates after a 127-day review. Its family tree reaches back 2 generations to 1999.

Decided: Sep 5, 2006
Review: 127 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K983831 (1999). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK983831 VECTORVISION2Brainlab AG · 1999
1 generation backK023424 Igi-SystemDenx Advanced Dental Systems · 2003
This deviceK061224 Lapdoc IRobodent GmbH · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K983831	VECTORVISION2	Brainlab AG	1999	—
−1	K023424	Igi-System	Denx Advanced Dental Systems	2003	—
0 (this device)	K061224	Lapdoc I	Robodent GmbH	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2004	1	0

FIG. 1 — Lineage of K061224, 1999–2006Source: 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.

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

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What was it cleared against? (4)

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
*	K023424	Igi-System Summary page 1 …ication name Stereotaxic Instrument (per 21 CFR section 880.4560 HAW) Regulatory Class: Class fi Predicate Devices: IGI-System (K023424) OrthoPilot (K003347) Vectorvision Cranial / ENT (K023651)…	Denx Advanced Dental Systems	2003	—
*	K003347	Orthopilot Summary page 1 …21 CFR section 880.4560 HAW) Regulatory Class: Class fi Predicate Devices: IGI-System (K023424) OrthoPilot (K003347) Vectorvision Cranial / ENT (K023651) Vectorvision 2 (K983831)…	Kinamed, Inc.	2001	—
*	K023651	Vectorvision Cranial/Ent Summary page 1 …Predicate Devices: IGI-System (K023424) OrthoPilot (K003347) Vectorvision Cranial / ENT (K023651) Vectorvision 2 (K983831) Classification: The FDA has classified "stereotaxic Instruments" dev…	Brainlab AG	2004	1
*	K983831	VECTORVISION2 Summary page 1 …OrthoPilot (K003347) Vectorvision Cranial / ENT (K023651) Vectorvision 2 (K983831) Classification: The FDA has classified "stereotaxic Instruments" devices as class II, pursuant to 21 CFR 882.4560 (product cod…	Brainlab AG	1999	—

Also cleared against K023424: 2 other devices →

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 7 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
1 of the 5 ancestors has a recall of any class.
2 other devices also cite its predicate K023424.

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 Lapdoc navigation system is a computerized navigational system intended to provide assistance in both the preoperative planning and the intra-operative surgical phases of dental implantation surgery. The system provides precise navigational guidance of surgical instruments such as a dental bur, with regard to the pre-operative planning in the dental implantation procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061224 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061224: Lapdoc I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061224

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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