510(k) · Cleared
ClearediVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · KNW Instrument, Biopsy
Cleared on Oct 5, 2017 as substantially equivalent to K070091 (Cardinal Health, Inc., 2007) after a 42-day review. Its family tree reaches back 4 generations to 1989. 1 later device descends from it.
- Decided
- Oct 5, 2017
- Review
- 42 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K890925 (1989). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 3 generations backK990515 Mathis Vertebral and Bone Biopsy SystemInternational Medical Systems · 1999
- 2 generations backK032943 Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body…Stryker Corp. · 2003
- 1 generation backK070091 Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Cardinal Health, Inc. · 2007
- This deviceK172558 iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone…Stryker Corporation · 2017
- Descendant · cites it directly · 0 of its ownK180327 Stryker iVAS 13g Bone Biopsy KitStryker Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K180327Stryker iVAS 13g Bone Biopsy KitStryker Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −3 | K990515 | Mathis Vertebral and Bone Biopsy System | International Medical Systems | 1999 | — |
| −2 | K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone… | Stryker Corp. | 2003 | — |
| −1 | K070091 | Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208 | Cardinal Health, Inc. | 2007 | — |
| 0 (this device) | K172558 | iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit | Stryker Corporation | 2017 | — |
| +1 | K180327 | Stryker iVAS 13g Bone Biopsy Kit | Stryker Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 KNW? 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 KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K070091 | Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Summary page 5…K172558 Stryker iVAS® Bone Biopsy Kit Regulation: 21CFR876.1075 3. Legally Marketed Predicate Device Predicate Device: Coaxial Bone and Vertebral Body Biopsy Needle (K070091) Reference Device: Stryker iVAS® 8G Bone Biopsy Kit (K141673) 4. Device Description The Stryker iVAS® Bone Biopsy Kit can be used… | 2007 |
| † | K141673 | Ivas 8 Gauge Bone Biopsy Kit | 2014 |
| † | K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180327 | Stryker iVAS 13g Bone Biopsy Kit | 2018 | 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?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K180327 (Stryker Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070091.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172558: iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172558
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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