510(k) · Cleared
ClearedStryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · KNW Instrument, Biopsy
Cleared on Dec 17, 2003 as substantially equivalent to K022169 (Parallax Medical, Inc., 2002) and 2 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1989. 29 later devices descend from it.
- Decided
- Dec 17, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K890925 (1989). 4 ancestors in all. 29 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 1 generation backK990515 Mathis Vertebral and Bone Biopsy SystemInternational Medical Systems · 1999
- This deviceK032943 Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body…Stryker Corp. · 2003
- Descendant · cites it directly · 18 of its ownK060148 Ebi Vertebroplasty SystemsEbi, L.P. · 2006
- Descendant · 2 generations on · 17 of its ownK063248 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
- Descendant · 3 generations on · 10 of its ownK070293 Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007
- Descendant · 4 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK070091 Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Cardinal Health, Inc. · 2007
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K060148Ebi Vertebroplasty SystemsEbi, L.P. · 2006 · cites it directly18descendants
- K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007 · 2 generations on17descendants
- K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007 · 3 generations on10descendants
- K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 4 generations on9descendants
- K070091Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Cardinal Health, Inc. · 2007 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −1 | K990515 | Mathis Vertebral and Bone Biopsy System | International Medical Systems | 1999 | — |
| 0 (this device) | K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone… | Stryker Corp. | 2003 | — |
| +1 | K060148 | Ebi Vertebroplasty Systems | Ebi, L.P. | 2006 | — |
| +2 | K063248 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | 2007 | — |
| +3 | K070293 | Benvenue VCF Osteo Coil System | Benvenue Medical, Inc. | 2007 | — |
| +4 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +1 | K070091 | Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208 | Cardinal Health, Inc. | 2007 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (3)
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 |
|---|---|---|---|
| * | K022169 | Clearview Plus Bone and Vertebral Body Biopsy NeedlesSummary page 1…s Classification Name: 876.1075 Gastroenterology-Urology Biopsy Instruments Equivalent to: Parallax Clearview Plus Bone and Vertebral Biopsy Needles (K022169), Parallax Bone and Vertebral Body Biopsy Needles (KO1 1206), IMS Mathis Verteb… | 2002 |
| * | K011206 | Parallax Bone and Vertebral Body Biopsy and Infusion Needles | 2001 |
| * | K990515 | Mathis Vertebral and Bone Biopsy SystemSummary page 1…les (K022169), Parallax Bone and Vertebral Body Biopsy Needles (KO1 1206), IMS Mathis Vertebral and Bone Biopsy System (K990515) Device Description: Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool… | 1999 |
What descends from it? (29)
See all 295 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060148 | Ebi Vertebroplasty Systems | 2006 | 18 |
| K070091 | Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208 | 2007 | 6 |
| K170008 | Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set | 2017 | 0 |
| K141673 | Ivas 8 Gauge Bone Biopsy Kit | 2014 | 0 |
| K052435 | Pneumrx Family of Biopsy Needles and Kits | 2005 | 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 14 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K060148 (Ebi, L.P., 2006) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K022169.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.
Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032943: Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032943
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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