510(k) Report

510(k) · Cleared

Cleared

Modification to Symphony Graft Delivery System

K022246510(k) SpecialCleared Aug 2, 200221-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

Depuyacromed · FMF Syringe, Piston

Cleared on Aug 2, 2002 as substantially equivalent to K003286 (Depuyacromed, 2001) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 2001. 51 later devices descend from it.

Decided
Aug 2, 2002
Review
21 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K003286 (2001). 2 ancestors in all. 51 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2007: 1 descendant cleared2006: 1 descendant cleared2012: 2 descendants cleared2014: 6 descendants cleared2010: 1 descendant cleared2015: 3 descendants cleared2011: 2 descendants cleared2016: 3 descendants cleared2019: 2 descendants cleared2017: 2 descendants cleared2023: 6 descendants cleared2020: 7 descendants cleared2018: 3 descendants cleared2024: 5 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2025: 2 descendants cleared2026: 1 descendant clearedK003286 · Symphony Graft Delivery System · Depuyacromed · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 5 descendants5 generations forward: 8 descendants6 generations forward: 18 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K003286 · Symphony Graft Delivery System · Depuyacromed · 20010+5
  1. Root · 1 generation backK003286 Symphony Graft Delivery SystemDepuyacromed · 2001
  2. This deviceK022246 Modification to Symphony Graft Delivery SystemDepuyacromed · 2002
  3. Descendant · cites it directly · 47 of its ownK072330 Controlled Delivery for Osteoplasty (Cdo System) and Graft…Biomet, Inc. · 2007
  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 · cites it directly · 37 of its ownK062365 Arthrex Aspirate KitArthrex, Inc. · 2006

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12010: 12011: 22012: 22014: 62015: 32016: 32017: 22018: 32019: 22020: 72021: 22022: 22023: 62024: 52025: 22026: 1
2006high 7 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 51 · See all
  • K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc. · 2007 · cites it directly47descendants
  • 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
  • K062365Arthrex Aspirate KitArthrex, Inc. · 2006 · cites it directly37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003286Symphony Graft Delivery SystemDepuyacromed2001—
0 (this device)K022246Modification to Symphony Graft Delivery SystemDepuyacromed2002—
+1K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.2007—
+2K100754Graft Delivery System Model SA-6115Micromedics, Inc.2010—
+3K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC2011—
+4K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC2012—
+1K062365Arthrex Aspirate KitArthrex, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
201010
201120
201220
201460
201530
201630
201720
201830
201920
202070
202120
202220
202360
202450
202520
202610
FIG. 1 — Lineage of K022246, 2001–2026Source: 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? (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
*K003286Symphony Graft Delivery System
Summary page 1
…2002 CLASSIFICATION NAME: Piston Syringe PROPRIETARY NAME: Symphony Graft Delivery System (GDS) PREDICATE DEVICES: Symphony Graft Delivery System (K003286, KO10320) INTENDED USE: The Symphony Graft Delivery System is indicated for the delivery o…
Depuyacromed2001—
*K010320Modification to Symphony Graft Delivery SystemDepuyacromed2001—

Also cleared against K003286: 6 other devices →

What descends from it? (51)

See all 51

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

NumberDeviceApplicantDecidedDescendants
K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.200747
K062365Arthrex Aspirate KitArthrex, 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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K072330 (Biomet, Inc., 2007) has gone furthest, with 47 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 Symphony Graft Delivery 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 I.V. 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
  • K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 20052 recalls
  • K021071PCCS Graft Delivery SystemBiomet, Inc. · 20021 recall
  • K012738Symphony Graft Delivery System (GDS)Depuyacromed · 2001

More from Depuyacromed

48 FDA decisions under this applicant name. See the company

  • K040197Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  • K031635Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030833Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  • K030249Surgical Titanium Mesh SystemDepuyacromed · 2003

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/K022246 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022246: Modification to Symphony Graft Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022246

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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