510(k) · Cleared
Recalled · Class II · 2014Imbibe Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovita, Inc. · LXH Orthopedic Manual Surgical Instrument
Cleared on Apr 1, 2014 as substantially equivalent to K050795 (Orthovita, Inc., 2005) after a 42-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 1, 2014
- Review
- 42 days
- Class
- Class I
- Product code
- LXH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K023088 (2002). 6 ancestors in all, the oldest K940025 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK023088 Bone Graft Syringe, Model 8600-00X0Wrightmedicaltechnologyinc · 2002
- 2 generations backK041991 Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc. · 2004
- 1 generation backK050795 Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc. · 2005
- This deviceK140414 Imbibe NeedleOrthovita, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK153306 Imbibe NeedleOrthovita, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K153306Imbibe NeedleOrthovita, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K023088 | Bone Graft Syringe, Model 8600-00X0 | Wrightmedicaltechnologyinc | 2002 | — |
| −2 | K041991 | Aspirex - Bone Marrow Aspirate Kit | Isotis Orthobiologics, Inc. | 2004 | — |
| −1 | K050795 | Imbibe Bone Marrow Aspiration Needle | Orthovita, Inc. | 2005 | — |
| 0 (this device) | K140414 | Imbibe Needle | Orthovita, Inc. | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 LXH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K050795 | Imbibe Bone Marrow Aspiration NeedleSummary page 1…Class: Class 11 Product Code: KNW LXH- 3. Predicate Device(s) Orthovita Inc.'s Imbibe Needle (K050795) 4. Device Description The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autol… | 2005 |
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 |
|---|---|---|---|
| K153306 | Imbibe Needle | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2014 | Class II | Z-0938-2015 | Package design/selection | There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K153306 (Orthovita, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K050795.
How does its category compare?
All LXH devicesLXH Orthopedic Manual Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LXH
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LXH
Too few LXH 510(k)s in any year since 2007 to give a median.
Recalls per year · LXH
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXH
6,119in 2025
MAUDE reports naming product code LXH, 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 | 0 | — | 41 | 398 |
| 2008 | 0 | — | 41 | 833 |
| 2009 | 0 | — | 25 | 1,569 |
| 2010 | 1 | — | 54 | 2,329 |
| 2011 | 0 | — | 12 | 2,488 |
| 2012 | 0 | — | 29 | 2,059 |
| 2013 | 0 | — | 17 | 4,149 |
| 2014 | 1 | — | 12 | 3,844 |
| 2015 | 0 | — | 7 | 5,944 |
| 2016 | 0 | — | 9 | 6,365 |
| 2017 | 0 | — | 14 | 4,133 |
| 2018 | 0 | — | 23 | 4,685 |
| 2019 | 1 | — | 10 | 5,224 |
| 2020 | 0 | — | 3 | 4,766 |
| 2021 | 0 | — | 2 | 4,832 |
| 2022 | 0 | — | 4 | 4,844 |
| 2023 | 0 | — | 4 | 5,163 |
| 2024 | 0 | — | 3 | 6,319 |
| 2025 | 0 | — | 0 | 6,119 |
| 2026 | 0 | — | 8 | — |
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/K140414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140414: 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/K140414
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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