510(k) · Cleared
ClearedStryker Navigation System Infinitus Hip Resurfacing Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · HAW Neurological Stereotaxic Instrument
Cleared on Dec 18, 2007 as substantially equivalent to K022365 (Stryker Instruments, 2003) and 1 other predicate after a 125-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Dec 18, 2007
- Review
- 125 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010612 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 3 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 2 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 1 generation backK063028 Vectorvision Hip SRBrainlab AG · 2006
- This deviceK072271 Stryker Navigation System Infinitus Hip Resurfacing ModuleStryker Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −3 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −2 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −1 | K063028 | Vectorvision Hip SR | Brainlab AG | 2006 | — |
| 0 (this device) | K072271 | Stryker Navigation System Infinitus Hip Resurfacing Module | Stryker Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 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? (2)
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 | Decided |
|---|---|---|---|
| * | K022365 | Stryker Navigation System - Hip ModuleSummary page 1…Hip Resurfacing Module Common Name: Navigation System Classification Name: Stereotaxic Instruments Equivalent to: K022365 Stryker Navigation -Hip Module K063028 VectorVision Hip SR Device Description: S… | 2003 |
| * | K063028 | Vectorvision Hip SRSummary page 1…em Classification Name: Stereotaxic Instruments Equivalent to: K022365 Stryker Navigation -Hip Module K063028 VectorVision Hip SR Device Description: Stryker® Navigation System - iNfinitus Hip Resurfacing Module is part of t… | 2006 |
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 6 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 6 other devices also cite its predicate K022365.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 is indicated for partial hip resurfacing, to assist in precise positioning of the femoral resurfacing component.
The system should be operated only by trained personnel such as orthopedic surgeons and clinic staff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072271: Stryker Navigation System Infinitus Hip Resurfacing Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072271
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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