510(k) Report

510(k) · Cleared

Cleared

Imbibe Bone Marrow Aspiration Syringe

K023074510(k) SpecialCleared Mar 11, 2003176-day reviewClass II21 CFR 880.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Orthovita, Inc. · FMF Syringe, Piston

Cleared on Mar 11, 2003 as substantially equivalent to K011087 (Orthovita, Inc., 2001) after a 176-day review. Its family tree reaches back 1 generation to 2001. 38 later devices descend from it.

Decided
Mar 11, 2003
Review
176 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011087 (2001). 38 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2012: 1 descendant cleared2016: 3 descendants cleared2015: 1 descendant cleared2014: 3 descendants cleared2019: 2 descendants cleared2017: 2 descendants cleared2023: 4 descendants cleared2020: 7 descendants cleared2018: 3 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2025: 2 descendants cleared2026: 1 descendant cleared2024: 4 descendants clearedK011087 · Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe · Orthovita, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 5 descendants4 generations forward: 3 descendants5 generations forward: 6 descendants6 generations forward: 15 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K011087 · Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe · Orthovita, Inc. · 20010+5
  1. Root · 1 generation backK011087 Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration SyringeOrthovita, Inc. · 2001
  2. This deviceK023074 Imbibe Bone Marrow Aspiration SyringeOrthovita, Inc. · 2003
  3. Descendant · cites it directly · 37 of its ownK062986 Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006
  4. Descendant · 2 generations on · 36 of its ownK121124 Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012
  5. Descendant · 3 generations on · 32 of its ownK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
  6. Descendant · 3 generations on · 31 of its ownK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
  7. Descendant · 4 generations on · 21 of its ownK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2006: 12012: 12014: 32015: 12016: 32017: 22018: 32019: 22020: 72021: 22022: 22023: 42024: 42025: 22026: 1
2006high 7 (2020) · low 0 (2007)2026

Most influential descendants

Showing 5 of 38 · See all
  • K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006 · cites it directly37descendants
  • K121124Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012 · 2 generations on36descendants
  • K133021Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014 · 3 generations on32descendants
  • K141245Etex Mixing and Delivery SystemEtex Corporation · 2014 · 3 generations on31descendants
  • K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016 · 4 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011087Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration SyringeOrthovita, Inc.2001—
0 (this device)K023074Imbibe Bone Marrow Aspiration SyringeOrthovita, Inc.2003—
+1K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.2006—
+2K121124Arthrex Mixing and Delivery SystemArthrex, Inc.2012—
+3K133021Mixing Syringe SystemZimmer Knee Creations, Inc.2014—
+3K141245Etex Mixing and Delivery SystemEtex Corporation2014—
+4K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201210
201430
201510
201630
201720
201830
201920
202070
202120
202220
202340
202440
202520
202610
FIG. 1 — Lineage of K023074, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FMF? 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 FMF device

  1. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K011087Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration SyringeOrthovita, Inc.2001—

Also cleared against K011087: 2 other devices →

What descends from it? (38)

See all 38

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.200637

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?

  • Its one ancestor has no recall.
  • Of its descendants, K062986 (Medtronic Sofamor Danek USA, Inc., 2006) has gone furthest, with 37 descendants of its own.
  • 2 other devices also cite its predicate K011087.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

What is it indicated for?

The Imbibe Bone Marrow Aspiration Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe can be filled with the surgeon’s choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix autologous blood or bone marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

Indications for use as stated in the FDA summary.

Also cleared against K011087

2 other devices cite the same predicate.

  • K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006
  • K043172Trugraft BGS Syringe, Model 600-041Osteobiologics, Inc. · 2005

More from Orthovita, Inc.

23 FDA decisions under this applicant name. See the company

  • K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
  • K161447HydroSet XTOrthovita, Inc. · 20162 recalls
  • K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc. · 2016
  • K153306Imbibe NeedleOrthovita, Inc. · 2015
  • K140868Stryker Kwic NeedleOrthovita, Inc. · 2014

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K023074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023074: Imbibe Bone Marrow Aspiration Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023074

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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