510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Harvest Graft Delivery Syringe

K043261510(k) TraditionalCleared Mar 11, 2005107-day reviewClass II21 CFR 880.5860Recalls 2

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

Harvest Technologies, Corp. · FMF Syringe, Piston

Cleared on Mar 11, 2005 as substantially equivalent to K003286 (Depuyacromed, 2001) and 3 other predicates after a 107-day review. Its family tree reaches back 3 generations to 2002. 51 later devices descend from it. It has been recalled 2 times.

Decided
Mar 11, 2005
Review
107 days
Class
Class II
Product code
FMF
Recalls
2
Predicates
4

Its longest line of descent runs back 3 generations to K013966 (2002). 8 ancestors in all, the oldest K994337 (2000). 51 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor2003: 1 other ancestor2000: 1 other ancestor2008: 1 descendant cleared2006: 2 descendants cleared2010: 1 descendant cleared2012: 2 descendants cleared2011: 2 descendants cleared2015: 3 descendants cleared2014: 5 descendants cleared2016: 3 descendants cleared2019: 2 descendants cleared2024: 5 descendants cleared2017: 2 descendants cleared2023: 6 descendants cleared2020: 7 descendants cleared2018: 3 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2025: 2 descendants cleared2026: 1 descendant clearedK013966 · Apatight-TCP Bone Graft Substitute · Cerabio, LLC · 2002K022629 · WMT-TCP Bone Graft Substitute · Wrightmedicaltechnologyinc · 2002K031817 · Cellplex TCP Synthetic Cancellous Bone · Wrightmedicaltechnologyinc · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 5 descendants5 generations forward: 9 descendants6 generations forward: 15 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K031817 · Cellplex TCP Synthetic Cancellous Bone · Wrightmedicaltechnologyinc · 2003K022629 · WMT-TCP Bone Graft Substitute · Wrightmedicaltechnologyinc · 2002K013966 · Apatight-TCP Bone Graft Substitute · Cerabio, LLC · 20020+5
  1. Root · 3 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
  2. 2 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
  3. 1 generation backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
  4. This deviceK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005
  5. Descendant · cites it directly · 45 of its ownK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  6. Descendant · 2 generations on · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
  7. Descendant · 3 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
  8. Descendant · cites it directly · 37 of its ownK062986 Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006
  9. Descendant · 2 generations on · 36 of its ownK121124 Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12010: 12011: 22012: 22014: 52015: 32016: 32017: 22018: 32019: 22020: 72021: 22022: 22023: 62024: 52025: 22026: 1
2006high 7 (2020) · low 0 (2007)2026

Most influential descendants

Showing 5 of 51 · See all
  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010 · cites it directly45descendants
  • K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · 2 generations on41descendants
  • K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 3 generations on40descendants
  • K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006 · cites it directly37descendants
  • K121124Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012 · 2 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K013966Apatight-TCP Bone Graft SubstituteCerabio, LLC2002—
−2K022629WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc2002—
−1K031817Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc2003—
0 (this device)K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.2005—
+1K100754Graft Delivery System Model SA-6115Micromedics, Inc.2010—
+2K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC2011—
+3K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC2012—
+1K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.2006—
+2K121124Arthrex Mixing and Delivery SystemArthrex, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200210
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
201010
201120
201220
201450
201530
201630
201720
201830
201920
202070
202120
202220
202360
202450
202520
202610
FIG. 1 — Lineage of K043261, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (4)

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
*K003286Symphony Graft Delivery System
Summary page 1
…other bone graft delivery systems; e.g., Symphony Graft Delivery System marketed by Depuy Acrorned (K003286), Wright Medical Technology Bone Graft Syringe (K023088) and INFLITRATE Marrow…
Depuyacromed2001—
*K023088Bone Graft Syringe, Model 8600-00X0
Summary page 1
…Delivery System marketed by Depuy Acrorned (K003286), Wright Medical Technology Bone Graft Syringe (K023088) and INFLITRATE Marrow Infusion Chamber (component of K031817), and the…
Wrightmedicaltechnologyinc2002—
*K031817Cellplex TCP Synthetic Cancellous Bone
Summary page 1
…edical Technology Bone Graft Syringe (K023088) and INFLITRATE Marrow Infusion Chamber (component of K031817), and the IsoTis Ortholliologics Aspirex-IBone Marrow Aspirate…
Wrightmedicaltechnologyinc2003—
*K041991Aspirex - Bone Marrow Aspirate Kit
Summary page 1
…n Chamber (component of K031817), and the IsoTis Ortholliologics Aspirex-IBone Marrow Aspirate Kit (K041991). Device Description: The Harvest Graft Delivery Systerm consists of a Graft S…
Isotis Orthobiologics, Inc.2004—

Also cleared against K003286: 6 other devices →

What descends from it? (51)

See all 51

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

NumberDeviceApplicantDecidedDescendants
K100754Graft Delivery System Model SA-6115Micromedics, Inc.201045
K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.200637
K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061
K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 20, 2017Class IIZ-0075-2018PackagingCertain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
Sep 11, 2013Class IIZ-0022-2014Device DesignPotential for leur connector to leak or have cracks.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 8 months on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K100754 (Micromedics, Inc., 2010) has gone furthest, with 45 descendants of its own.
  • 6 other devices also cite its predicate K003286.

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 Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), IV. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

Indications for use as stated in the FDA summary.

Also cleared against K003286

6 other devices cite the same predicate.

  • K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015Depuy Spine, Inc. · 2008
  • K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006
  • K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc. · 2006
  • K022246Modification to Symphony Graft Delivery SystemDepuyacromed · 2002
  • K021071PCCS Graft Delivery SystemBiomet, Inc. · 20021 recall
  • K012738Symphony Graft Delivery System (GDS)Depuyacromed · 2001

More from Harvest Technologies, Corp.

6 FDA decisions under this applicant name. See the company

  • K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 20121 recall
  • K103340SMARTPREP2 Bmac System, Smartprep Platelet Concentration SystemHarvest Technologies, Corp. · 20102 recalls
  • K052925SMARTPREP2 Centrifuge SystemHarvest Technologies, Corp. · 20062 recalls
  • K020252Smartjet Grafting Liquid Applicator, Models SK/S & LK/2Harvest Technologies, Corp. · 2002
  • K011032Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone Graft Liquid Applicator (Dual…Harvest Technologies, Corp. · 2001

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/K043261 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043261: Harvest Graft Delivery Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043261

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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