510(k) · Cleared
ClearedStryker Orthopaedics Rfid Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HAW Neurological Stereotaxic Instrument
Cleared on Aug 4, 2006 as substantially equivalent to K022365 (Stryker Instruments, 2003) and 3 other predicates after a 245-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Aug 4, 2006
- Review
- 245 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K905070 (1991). 23 ancestors in all, the oldest K861692 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 6 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 5 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 4 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 3 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 2 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 1 generation backK043223 Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc. · 2005 · Recalled
- This deviceK053348 Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −7 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −6 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −5 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −4 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −3 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −2 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −1 | K043223 | Depuy Cas Knee Instrumentation | DePuy Orthopaedics, Inc. | 2005 | 1 |
| 0 (this device) | K053348 | Stryker Orthopaedics Rfid Instrumentation | Howmedica Osteonics Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | K022365 | Stryker Navigation System - Hip ModuleSummary page 1…d use, design, materials, and operational principles. The following devices are examples of predicate devices: 1) Hip and Knee Modules of the Stryker® Navigation System (K022365 and KOI 0204), 2) Smith and Nephew Image Guided Surgical Instruments (K033341) and 3) DePuy CAS Knee Instrumentation (K043223).… | 2003 |
| * | K010204 | Stryker Navigation System-Knee Module | 2001 |
| * | K033341 | Smith & Nephew Image Guided Surgical Instruments for Hip ApplicationsSummary page 1…e examples of predicate devices: 1) Hip and Knee Modules of the Stryker® Navigation System (K022365 and KOI 0204), 2) Smith and Nephew Image Guided Surgical Instruments (K033341) and 3) DePuy CAS Knee Instrumentation (K043223).… | 2004 |
| * | K043223 | Depuy Cas Knee InstrumentationSummary page 1…Modules of the Stryker® Navigation System (K022365 and KOI 0204), 2) Smith and Nephew Image Guided Surgical Instruments (K033341) and 3) DePuy CAS Knee Instrumentation (K043223). 6 DEPAR… | 2005 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 23 ancestors have 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.
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?
Stryker ® Orthopaedics RFID Instrumentation is intended for use as accessories to the
Stryker ® Navigation System's Hip and Knee Modules during orthopedic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053348 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053348: Stryker Orthopaedics Rfid Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053348
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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