510(k) · Cleared

Cleared

Stryker Navigation System-Knee Module

K010204510(k) TraditionalCleared Aug 31, 2001220-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

Stryker Corp. · HAW Neurological Stereotaxic Instrument

Cleared on Aug 31, 2001 after a 220-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 158 later devices descend from it.

Decided: Aug 31, 2001
Review: 220 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 0

158 later devices descend from it, 5 citing it directly.

This deviceK010204 Stryker Navigation System-Knee ModuleStryker Corp. · 2001
Descendant · cites it directly · 153 of its ownK013569 Orthopilot 2Aesculap, Inc. · 2002
Descendant · 2 generations on · 126 of its ownK061362 Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006
Descendant · 2 generations on · 83 of its ownK050752 Aesculap Orthopilot 2 Tha V 2.0Aesculap, Inc. · 2005
Descendant · 3 generations on · 81 of its ownK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
Descendant · 3 generations on · 79 of its ownK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008

Showing 5 of 158 descendants. See all descendants

Descendants cleared per year

2002high 16 (2020) · low 0 (2003)2026

Most influential descendants

Showing 5 of 158 · See all

K013569Orthopilot 2Aesculap, Inc. · 2002 · cites it directly153descendants
K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG · 2006 · 2 generations on126descendants
K050752Aesculap Orthopilot 2 Tha V 2.0Aesculap, Inc. · 2005 · 2 generations on83descendants
K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007 · 3 generations on81descendants
K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008 · 3 generations on79descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010204	Stryker Navigation System-Knee Module	Stryker Corp.	2001	—
+1	K013569	Orthopilot 2	Aesculap, Inc.	2002	—
+2	K061362	Pigalileo Total Knee Replacement (TKR) System	Plus Orthopedics AG	2006	—
+2	K050752	Aesculap Orthopilot 2 Tha V 2.0	Aesculap, Inc.	2005	—
+3	K070731	Pigalileo Total Hip Replacement (THR) System	Plus Orthopedics AG	2007	—
+3	K080875	Pigalileo 4TH Generation System	Smith & Nephew, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2005	1	0
2006	2	0
2007	1	0
2008	6	0
2009	6	0
2010	4	0
2011	3	0
2012	3	0
2013	2	0
2014	5	0
2015	2	0
2016	4	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 K010204, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (158)

See all 158

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

Number	Device	Applicant	Decided	Descendants
K013569	Orthopilot 2	Aesculap, Inc.	2002	153
K080450	Stryker Power Tool Navigator Attachment	Stryker Corp.	2008	1
K140689	Iknee Distal Femoral Cutting Guide	Evergreen Orthopedic Research Lab	2014	0
K053348	Stryker Orthopaedics Rfid Instrumentation	Howmedica Osteonics Corp.	2006	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?

Of its descendants, K013569 (Aesculap, Inc., 2002) has gone furthest, with 153 descendants of its own.

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	—

https://510kreport.com/device/K010204 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010204: Stryker Navigation System-Knee Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010204

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026