510(k) · Cleared
ClearedCoaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · KNW Instrument, Biopsy
Cleared on Apr 18, 2007 as substantially equivalent to K032943 (Stryker Corp., 2003) after a 98-day review. Its family tree reaches back 3 generations to 1989. 6 later devices descend from it.
- Decided
- Apr 18, 2007
- Review
- 98 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K890925 (1989). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 2 generations backK990515 Mathis Vertebral and Bone Biopsy SystemInternational Medical Systems · 1999
- 1 generation backK032943 Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body…Stryker Corp. · 2003
- This deviceK070091 Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Cardinal Health, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK171531 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle…Care Fusion · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK172558 iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone…Stryker Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK242322 Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK192099 MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration…Medax Srl Unipersonale · 2020
- Descendant · 2 generations on · 0 of its ownK190177 J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone…Ranfac Corporation · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…Care Fusion · 2017 · cites it directly3descendants
- K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitStryker Corporation · 2017 · cites it directly1descendant
- K242322Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale · 2020 · 2 generations on0descendants
- K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −2 | K990515 | Mathis Vertebral and Bone Biopsy System | International Medical Systems | 1999 | — |
| −1 | K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone… | Stryker Corp. | 2003 | — |
| 0 (this device) | K070091 | Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208 | Cardinal Health, Inc. | 2007 | — |
| +1 | K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow… | Care Fusion | 2017 | 6 |
| +1 | K172558 | iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit | Stryker Corporation | 2017 | — |
| +2 | K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025 | — |
| +2 | K192099 | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle… | Medax Srl Unipersonale | 2020 | — |
| +2 | K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow… | Ranfac Corporation | 2019 | — |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K813338 | FDA’s K813338 is Biopsy Needles & Trays Our reading of the summary gave K813338, FDA’s number for Biopsy Needles & Trays (American Pharmaseal Div. Ahsc). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cardinal Health Jamshidi Coaxial Bone Biopsy Needle”. Kept off the family tree. Summary page 1…Class IIper 21 CFR §876.1075 Predicate Devices: Cardinal Health Jamshidi Coaxial Bone Biopsy Needle, (K813338) Stryker Bone and Vertebral Body Biopsy Kit (K0… | 1982 |
| * | K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy KitsSummary page 1…Bone Biopsy Needle, (K813338) Stryker Bone and Vertebral Body Biopsy Kit (K032943) Description: This device can be used as a standalone device… | 2003 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K171531 (Care Fusion, 2017) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K032943.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
This device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070091: Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070091
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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