510(k) Report

510(k) · Cleared

Cleared

Medtronic Graft Delivery Syringe

K062986510(k) TraditionalCleared Dec 8, 200670-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

Medtronic Sofamor Danek USA, Inc. · FMF Syringe, Piston

Cleared on Dec 8, 2006 as substantially equivalent to K043261 (Harvest Technologies, Corp., 2005) and 4 other predicates after a 70-day review. Its family tree reaches back 4 generations to 2002. 37 later devices descend from it.

Decided
Dec 8, 2006
Review
70 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K013966 (2002). 11 ancestors in all, the oldest K994337 (2000). 37 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2001: 2 other ancestors2004: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor2012: 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 clearedK013966 · Apatight-TCP Bone Graft Substitute · Cerabio, LLC · 2002K022629 · WMT-TCP Bone Graft Substitute · Wrightmedicaltechnologyinc · 2002K031817 · Cellplex TCP Synthetic Cancellous Bone · Wrightmedicaltechnologyinc · 2003K043261 · Harvest Graft Delivery Syringe · Harvest Technologies, Corp. · 2005 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 6 descendants5 generations forward: 15 descendants6 generations forward: 5 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant K043261 · Harvest Graft Delivery Syringe · Harvest Technologies, Corp. · 2005 · recalledK031817 · 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 · 4 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
  2. 3 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
  3. 2 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
  4. 1 generation backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
  5. This deviceK062986 Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006
  6. Descendant · cites it directly · 36 of its ownK121124 Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012
  7. Descendant · 2 generations on · 32 of its ownK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
  8. Descendant · 2 generations on · 31 of its ownK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
  9. Descendant · 3 generations on · 21 of its ownK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
  10. Descendant · 4 generations on · 11 of its ownK170675 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2012: 12014: 32015: 12016: 32017: 22018: 32019: 22020: 72021: 22022: 22023: 42024: 42025: 22026: 1
2012high 7 (2020) · low 0 (2013)2026

Most influential descendants

Showing 5 of 37 · See all
  • K121124Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012 · cites it directly36descendants
  • K133021Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014 · 2 generations on32descendants
  • K141245Etex Mixing and Delivery SystemEtex Corporation · 2014 · 2 generations on31descendants
  • K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016 · 3 generations on21descendants
  • K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017 · 4 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K013966Apatight-TCP Bone Graft SubstituteCerabio, LLC2002—
−3K022629WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc2002—
−2K031817Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc2003—
−1K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.20052
0 (this device)K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.2006—
+1K121124Arthrex Mixing and Delivery SystemArthrex, Inc.2012—
+2K133021Mixing Syringe SystemZimmer Knee Creations, Inc.2014—
+2K141245Etex Mixing and Delivery SystemEtex Corporation2014—
+3K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.2016—
+4K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200210
200320
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201430
201510
201630
201720
201830
201920
202070
202120
202220
202340
202440
202520
202610
FIG. 1 — Lineage of K062986, 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? (5)

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
*K043261Harvest Graft Delivery Syringe
Summary page 1
…ry Syringe to be substantially equivalent to previously cleared graft delivery systems such as Harvest Technologies Corp.'s Harvest Graft Delivery System, (K043261, SE 03/11/05), Depuy's Symphony Graft Delivery System, K003286 (01/18/01), the Imbibe Piston Syringe (KO I1087, SE…
Harvest Technologies, Corp.20052
*K003286Symphony Graft Delivery System
Summary page 1
…graft delivery systems such as Harvest Technologies Corp.'s Harvest Graft Delivery System, (K043261, SE 03/11/05), Depuy's Symphony Graft Delivery System, K003286 (01/18/01), the Imbibe Piston Syringe (KO I1087, SE 09/19/01), the Imbibe Bone Marrow Aspiration Syringe (K023074, SE 03/1…
Depuyacromed2001—
*K011087Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration SyringeOrthovita, Inc.2001—
*K023074Imbibe Bone Marrow Aspiration Syringe
Summary page 1
…, Depuy's Symphony Graft Delivery System, K003286 (01/18/01), the Imbibe Piston Syringe (KO I1087, SE 09/19/01), the Imbibe Bone Marrow Aspiration Syringe (K023074, SE 03/11/03) and the Imbibe II Piston Syringe, (K030208, SE 04/16/03). DEPARTMENT OF HEALTH & HUMAN SE…
Orthovita, Inc.2003—
*K030208Imbibe II Syringe
Summary page 1
…01), the Imbibe Piston Syringe (KO I1087, SE 09/19/01), the Imbibe Bone Marrow Aspiration Syringe (K023074, SE 03/11/03) and the Imbibe II Piston Syringe, (K030208, SE 04/16/03). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Ser…
Orthovita, Inc.2003—

Also cleared against K043261: 3 other devices →

What descends from it? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K121124Arthrex Mixing and Delivery SystemArthrex, Inc.201236

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 4 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K121124 (Arthrex, Inc., 2012) has gone furthest, with 36 descendants of its own.
  • 3 other devices also cite its predicate K043261.

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 Medtronic Graft Delivery Syringe is intended to provide the surgeon with a means to mix autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic bone graft materials and to deliver these materials to all orthopaedic surgical sites.

Indications for use as stated in the FDA summary.

Also cleared against K043261

3 other devices cite the same predicate.

  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  • K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015Depuy Spine, Inc. · 2008
  • K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc. · 2006

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

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/K062986 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062986: Medtronic 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/K062986

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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