510(k) · Cleared

Cleared

Orthopilot 2

K013569510(k) TraditionalCleared Apr 4, 2002157-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 Apr 4, 2002 as substantially equivalent to K003347 (Kinamed, Inc., 2001) and 3 other predicates after a 157-day review. Its family tree reaches back 1 generation to 2001. 153 later devices descend from it.

Decided: Apr 4, 2002
Review: 157 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K003347 (2001). 4 ancestors in all. 153 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK003347 OrthopilotKinamed, Inc. · 2001
This deviceK013569 Orthopilot 2Aesculap, Inc. · 2002
Descendant · cites it directly · 126 of its ownK061362 Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
Descendant · cites it directly · 83 of its ownK050752 Aesculap Orthopilot 2 Tha V 2.0Aesculap, Inc. · 2005
Descendant · 2 generations on · 81 of its ownK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
Descendant · 2 generations on · 79 of its ownK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
Descendant · 3 generations on · 78 of its ownK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009

Showing 5 of 153 descendants. See all descendants

Descendants cleared per year

2002high 16 (2020) · low 0 (2003)2026

Most influential descendants

Showing 5 of 153 · See all

K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006 · cites it directly126descendants
K050752Aesculap Orthopilot 2 Tha V 2.0Aesculap, Inc. · 2005 · cites it directly83descendants
K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007 · 2 generations on81descendants
K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008 · 2 generations on79descendants
K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009 · 3 generations on78descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003347	Orthopilot	Kinamed, Inc.	2001	—
0 (this device)	K013569	Orthopilot 2	Aesculap, Inc.	2002	—
+1	K061362	Pigalileo Total Knee Replacement (TKR) System	Plus Orthopedics AG	2006	—
+1	K050752	Aesculap Orthopilot 2 Tha V 2.0	Aesculap, Inc.	2005	—
+2	K070731	Pigalileo Total Hip Replacement (THR) System	Plus Orthopedics AG	2007	—
+2	K080875	Pigalileo 4TH Generation System	Smith & Nephew, Inc.	2008	—
+3	K090420	Smith & Nephew Pigalileo Screw Targeting System V 1.0	Smith & Nephew, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2006	1	0
2007	1	0
2008	5	0
2009	6	0
2010	4	0
2011	3	0
2012	3	0
2013	2	0
2014	4	0
2015	2	0
2016	3	0
2017	14	0
2018	5	0
2019	5	0
2020	16	0
2021	12	0
2022	6	0
2023	16	0
2024	14	0
2025	14	0
2026	15	0

FIG. 1 — Lineage of K013569, 2001–2026Source: 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
*	K003347	Orthopilot Summary page 2 …Substantial Equivalence: Aesculap’s Orthopilot® 2 Navigation Platform is substantially equivalent to existing devices cleared by FDA. They are as follows: Orthopilot® (K003347) e Stryker Navigation System-Knee Module (K010204) e Brainlab Vector Vision Knee (K010612) e Brainlab Vector Vision Hip {K01060…	Kinamed, Inc.	2001	—
*	K010204	Stryker Navigation System-Knee Module Summary page 2 …avigation Platform is substantially equivalent to existing devices cleared by FDA. They are as follows: Orthopilot® (K003347) e Stryker Navigation System-Knee Module (K010204) e Brainlab Vector Vision Knee (K010612) e Brainlab Vector Vision Hip {K010602) & REALTY O L g SERVICES. » […	Stryker Corp.	2001	—
*	K010612	Vectorvision Knee Summary page 2 …valent to existing devices cleared by FDA. They are as follows: Orthopilot® (K003347) e Stryker Navigation System-Knee Module (K010204) e Brainlab Vector Vision Knee (K010612) e Brainlab Vector Vision Hip {K010602) & REALTY O L g SERVICES. » [ . ty __/C DEPARTMENT OF HEALTH & HUMAN…	Brainlab AG	2001	—
*	K010602	Vectorvision Hip Summary page 2 …A. They are as follows: Orthopilot® (K003347) e Stryker Navigation System-Knee Module (K010204) e Brainlab Vector Vision Knee (K010612) e Brainlab Vector Vision Hip {K010602) & REALTY O L g SERVICES. » [ . ty __/C DEPARTMENT OF HEALTH & HUMAN SERVICES * Public Health Service Food a…	Brainlab AG	2001	—

Also cleared against K003347: 8 other devices →

What descends from it? (153)

See all 153

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061362	Pigalileo Total Knee Replacement (TKR) System	Plus Orthopedics AG	2006	126
K050752	Aesculap Orthopilot 2 Tha V 2.0	Aesculap, Inc.	2005	83
K080547	Orthopilot Next Generation, Model FS101-FS106	Aesculap Implant System, Inc.	2008	22
K072899	Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0	Aesculap Implant Systems, Inc.	2008	0
K021327	Orthopilot Hto Module	Aesculap, Inc.	2002	0

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?

None of the 4 ancestors has a recall.
Of its descendants, K061362 (Plus Orthopedics AG, 2006) has gone furthest, with 126 descendants of its own.
8 other devices also cite its predicate K003347.

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® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement. (Does not include an indication for High Tibial Osteotomy (HTO) module).

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/K013569 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013569: Orthopilot 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013569

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026