510(k) Report

510(k) · Cleared

Cleared

Aspirex - Bone Marrow Aspirate Kit

K041991510(k) AbbreviatedCleared Sep 16, 200455-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

Isotis Orthobiologics, Inc. · FMF Syringe, Piston

Cleared on Sep 16, 2004 as substantially equivalent to K030208 (Orthovita, Inc., 2003) and 1 other predicate after a 55-day review. Its family tree reaches back 1 generation to 2002. 73 later devices descend from it.

Decided
Sep 16, 2004
Review
55 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K023088 (2002). 2 ancestors in all. 73 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2005: 3 descendants cleared2006: 3 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2015: 6 descendants cleared2014: 8 descendants cleared2012: 2 descendants cleared2011: 2 descendants cleared2016: 3 descendants cleared2019: 4 descendants cleared2018: 4 descendants cleared2024: 6 descendants cleared2025: 3 descendants cleared2021: 5 descendants cleared2026: 2 descendants cleared2023: 7 descendants cleared2020: 8 descendants cleared2017: 2 descendants cleared2022: 2 descendants clearedK023088 · Bone Graft Syringe, Model 8600-00X0 · Wrightmedicaltechnologyinc · 2002200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 10 descendants3 generations forward: 19 descendants4 generations forward: 8 descendants5 generations forward: 8 descendants6 generations forward: 18 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K023088 · Bone Graft Syringe, Model 8600-00X0 · Wrightmedicaltechnologyinc · 20020+5
  1. Root · 1 generation backK023088 Bone Graft Syringe, Model 8600-00X0Wrightmedicaltechnologyinc · 2002
  2. This deviceK041991 Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc. · 2004
  3. Descendant · cites it directly · 51 of its ownK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
  4. Descendant · 2 generations on · 45 of its ownK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  5. Descendant · 3 generations on · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
  6. Descendant · 4 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
  7. Descendant · 2 generations on · 37 of its ownK062986 Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2005: 32006: 32008: 12010: 12011: 22012: 22013: 12014: 82015: 62016: 32017: 22018: 42019: 42020: 82021: 52022: 22023: 72024: 62025: 32026: 2
2005high 8 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 73 · See all
  • K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · cites it directly51descendants
  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010 · 2 generations on45descendants
  • K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · 3 generations on41descendants
  • K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 4 generations on40descendants
  • K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006 · 2 generations on37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K023088Bone Graft Syringe, Model 8600-00X0Wrightmedicaltechnologyinc2002—
0 (this device)K041991Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc.2004—
+1K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.20052
+2K100754Graft Delivery System Model SA-6115Micromedics, Inc.2010—
+3K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC2011—
+4K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC2012—
+2K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200530
200630
200810
201010
201120
201220
201310
201480
201560
201630
201720
201840
201940
202080
202150
202220
202370
202460
202530
202620
FIG. 1 — Lineage of K041991, 2002–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K030208Imbibe II Syringe
Summary page 1
…Piston Syringe Classification Name: Piston Syringe (Product Code FMF) Predicate Devices Proprietary Name: OrthoVita IMBIBE' II Syringe (K030208) Wright Medical Bone Graft Syringe (K023088) Intended Use AspirexTM - Bone Marrow Aspirate Kit…
Orthovita, Inc.2003—
*K023088Bone Graft Syringe, Model 8600-00X0
Summary page 1
…Code FMF) Predicate Devices Proprietary Name: OrthoVita IMBIBE' II Syringe (K030208) Wright Medical Bone Graft Syringe (K023088) Intended Use AspirexTM - Bone Marrow Aspirate Kit is for the aspiration of bone marrow, autologous blood, plasma or other bl…
Wrightmedicaltechnologyinc2002—

Also cleared against K030208: 6 other devices →

What descends from it? (73)

See all 73

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.200551
K062365Arthrex Aspirate KitArthrex, Inc.200637
K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc.200519

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K043261 (Harvest Technologies, Corp., 2005) has gone furthest, with 51 descendants of its own.
  • 6 other devices also cite its predicate K030208.

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?

Aspirex TM - Bone Marrow Aspirate Kit is for the aspiration of bone marrow, autologous blood, plasma or other blood components with or without prefilling with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). The kit provides a convenient way to mix autologous blood or bone marrow with bone void filler and deliver to the orthopedic surgical site.

Indications for use as stated in the FDA summary.

Also cleared against K030208

6 other devices cite the same predicate.

  • K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015Depuy Spine, Inc. · 2008
  • K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc. · 2007
  • K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006
  • K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc. · 2006
  • K043172Trugraft BGS Syringe, Model 600-041Osteobiologics, Inc. · 2005
  • K032130Vitoss-Filled CartridgeOrthovita, Inc. · 2003

More from Isotis Orthobiologics, Inc.

10 FDA decisions under this applicant name. See the company

  • K091193Accell EVO3CIsotis Orthobiologics, Inc. · 20091 recall
  • K081817Accell TBM-RIsotis Orthobiologics, Inc. · 2008
  • K070751Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc. · 2007
  • K050642Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005
  • K052098Connexus, .5CC, Model 023000-005Isotis Orthobiologics, Inc. · 2005

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/K041991 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041991: Aspirex - Bone Marrow Aspirate Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041991

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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