510(k) · Cleared
ClearedImbibe Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovita, Inc. · KNW Instrument, Biopsy
Cleared on Dec 18, 2015 as substantially equivalent to K140414 (Orthovita, Inc., 2014) after a 32-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Dec 18, 2015
- Review
- 32 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K023088 (2002). 7 ancestors in all, the oldest K940025 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK023088 Bone Graft Syringe, Model 8600-00X0Wrightmedicaltechnologyinc · 2002
- 3 generations backK041991 Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc. · 2004
- 2 generations backK050795 Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc. · 2005
- 1 generation backK140414 Imbibe NeedleOrthovita, Inc. · 2014 · Recalled
- This deviceK153306 Imbibe NeedleOrthovita, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K023088 | Bone Graft Syringe, Model 8600-00X0 | Wrightmedicaltechnologyinc | 2002 | — |
| −3 | K041991 | Aspirex - Bone Marrow Aspirate Kit | Isotis Orthobiologics, Inc. | 2004 | — |
| −2 | K050795 | Imbibe Bone Marrow Aspiration Needle | Orthovita, Inc. | 2005 | — |
| −1 | K140414 | Imbibe Needle | Orthovita, Inc. | 2014 | 1 |
| 0 (this device) | K153306 | Imbibe Needle | Orthovita, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K140414 | Imbibe NeedleSummary page 4…ument and Numbers 21 CFR §876.1075 21 CFR §888.4540 Product Code KNW LXH Predicate Devices Stryker Imbibe Needle (K140414) Device Description The Imbibe Needle is a manually operated surgical instrument to assist with the as… | 2014 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153306: Imbibe Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153306
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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