510(k) · Cleared
Recalled · Class II · 2015Stryker Navigation System - Hip Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · HAW Neurological Stereotaxic Instrument
Cleared on Jan 22, 2003 after a 184-day review. The FDA summary names no predicate by number. 125 later devices descend from it. It has been recalled 10 times.
- Decided
- Jan 22, 2003
- Review
- 184 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 10
- Predicates
- 0
125 later devices descend from it, 7 citing it directly.
- This deviceK022365 Stryker Navigation System - Hip ModuleStryker Instruments · 2003
- Descendant · cites it directly · 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
- Descendant · 4 generations on · 77 of its ownK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- Descendant · 5 generations on · 75 of its ownK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 125 · See all- K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007 · cites it directly81descendants
- 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
- K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009 · 4 generations on77descendants
- K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · 5 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022365 | Stryker Navigation System - Hip Module | Stryker Instruments | 2003 | — |
| +1 | 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 | — |
| +4 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| +5 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 15 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 13 | 0 |
| 2021 | 10 | 0 |
| 2022 | 5 | 0 |
| 2023 | 13 | 0 |
| 2024 | 11 | 0 |
| 2025 | 7 | 0 |
| 2026 | 12 | 0 |
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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (125)
See all 1257 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070731 | Pigalileo Total Hip Replacement (THR) System | 2007 | 81 |
| K050615 | Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000 | 2005 | 29 |
| K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | 2010 | 11 |
| K162937 | Stryker OrthoMap Versatile Hip System | 2017 | 9 |
| K080450 | Stryker Power Tool Navigator Attachment | 2008 | 1 |
| K072271 | Stryker Navigation System Infinitus Hip Resurfacing Module | 2007 | 0 |
| K053348 | Stryker Orthopaedics Rfid Instrumentation | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2015 | Class II | Z-1810-2015 | Process control | Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct… |
| Jun 5, 2008 | Not classified | Z-2288-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2294-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2291-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2289-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2292-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2293-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jun 5, 2008 | Not classified | Z-2290-2008 | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. |
| Jul 14, 2004 | Not classified | Z-0021-05 | Other | The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system. |
| Jul 14, 2004 | Not classified | Z-0020-05 | Other | The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070731 (Plus Orthopedics AG, 2007) has gone furthest, with 81 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 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 system must be used within the operating theatre and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.
The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures
Any form of Total Hip Athroplasty (THA), e.g. open of minimal-invasive
Precisely position instruments, implants and bony tissue during orthopedic surgery, such as operations performed with Hip and bones in the upper extremities
Revisions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022365: Stryker Navigation System - Hip Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022365
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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