510(k) · Cleared

Cleared

Orthopilot Hto Module

K021327510(k) TraditionalCleared Jul 25, 200290-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

Aesculap, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Jul 25, 2002 as substantially equivalent to K013569 (Aesculap, Inc., 2002) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 2001.

Decided: Jul 25, 2002
Review: 90 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K003347 (2001). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK003347 OrthopilotKinamed, Inc. · 2001
1 generation backK013569 Orthopilot 2Aesculap, Inc. · 2002
This deviceK021327 Orthopilot Hto ModuleAesculap, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003347	Orthopilot	Kinamed, Inc.	2001	—
−1	K013569	Orthopilot 2	Aesculap, Inc.	2002	—
0 (this device)	K021327	Orthopilot Hto Module	Aesculap, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	3	0

FIG. 1 — Lineage of K021327, 2001–2002Source: 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

Get a 510(k) Report

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
*	K013569	Orthopilot 2	Aesculap, Inc.	2002	—
*	K003347	Orthopilot Summary page 2 …VALENCE Aesculap@,Inc. believes that the Orthopilot@HTO module is essentially identical to the Orthopilot@2 Navigation Platform (subjected KO1 3569), Kinamed Orthopilot@(K003347), Stryker Navigation System-Knee Module (KO10204), Brainlab Vector Vision Knee (KO 1 061 2).…	Kinamed, Inc.	2001	—
*	K010204	Stryker Navigation System-Knee Module	Stryker Corp.	2001	—
*	K010612	Vectorvision Knee	Brainlab AG	2001	—

Also cleared against K013569: 4 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 1 year and passes through 2 companies; a new generation was cleared every 1.1 years on median.
None of the 5 ancestors has a recall.
4 other devices also cite its predicate K013569.

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 Orthopilot@HTO module is designed to assist an orthopedic surgeon to navigate the two bone cuts to form the wedge for correction of the leg axis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021327 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021327: Orthopilot Hto Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021327

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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