510(k) · Cleared
ClearedParallax Bone and Vertebral Body Biopsy and Infusion Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parallax Medical, Inc. · KNW Instrument, Biopsy
Cleared on Jul 18, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it.
- Decided
- Jul 18, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 2 citing it directly.
- This deviceK011206 Parallax Bone and Vertebral Body Biopsy and Infusion NeedlesParallax Medical, Inc. · 2001
- Descendant · cites it directly · 34 of its ownK022169 Clearview Plus Bone and Vertebral Body Biopsy NeedlesParallax Medical, Inc. · 2002
- Descendant · cites it directly · 29 of its ownK032943 Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body…Stryker Corp. · 2003
- Descendant · 2 generations on · 18 of its ownK060148 Ebi Vertebroplasty SystemsEbi, L.P. · 2006
- Descendant · 3 generations on · 17 of its ownK063248 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
- Descendant · 4 generations on · 10 of its ownK070293 Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K022169Clearview Plus Bone and Vertebral Body Biopsy NeedlesParallax Medical, Inc. · 2002 · cites it directly34descendants
- K032943Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy KitsStryker Corp. · 2003 · cites it directly29descendants
- K060148Ebi Vertebroplasty SystemsEbi, L.P. · 2006 · 2 generations on18descendants
- K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007 · 3 generations on17descendants
- K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011206 | Parallax Bone and Vertebral Body Biopsy and Infusion Needles | Parallax Medical, Inc. | 2001 | — |
| +1 | K022169 | Clearview Plus Bone and Vertebral Body Biopsy Needles | Parallax Medical, Inc. | 2002 | — |
| +1 | K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone… | Stryker Corp. | 2003 | — |
| +2 | K060148 | Ebi Vertebroplasty Systems | Ebi, L.P. | 2006 | — |
| +3 | K063248 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | 2007 | — |
| +4 | K070293 | Benvenue VCF Osteo Coil System | Benvenue Medical, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (35)
See all 352 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?
- Of its descendants, K022169 (Parallax Medical, Inc., 2002) has gone furthest, with 34 descendants of its own.
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) | — |
https://510kreport.com/device/K011206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011206: Parallax Bone and Vertebral Body Biopsy and Infusion Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011206
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026