510(k) · Cleared

Cleared

Symphony Graft Delivery System (GDS)

K012738510(k) TraditionalCleared Nov 14, 200190-day reviewClass I21 CFR 878.4820

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

Depuyacromed · GEY Motor, Surgical Instrument, Ac-Powered

Cleared on Nov 14, 2001 as substantially equivalent to K003286 (Depuyacromed, 2001) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 2001. 38 later devices descend from it.

Decided: Nov 14, 2001
Review: 90 days
Class: Class I
Product code: GEY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K003286 (2001). 2 ancestors in all. 38 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK003286 Symphony Graft Delivery SystemDepuyacromed · 2001
This deviceK012738 Symphony Graft Delivery System (GDS)Depuyacromed · 2001
Descendant · cites it directly · 37 of its ownK062365 Arthrex Aspirate KitArthrex, Inc. · 2006
Descendant · cites it directly · 36 of its ownK121124 Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012
Descendant · 2 generations on · 32 of its ownK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
Descendant · 2 generations on · 31 of its ownK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
Descendant · 3 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

2006high 7 (2020) · low 0 (2007)2026

Most influential descendants

Showing 5 of 38 · See all

K062365Arthrex Aspirate KitArthrex, Inc. · 2006 · cites it directly37descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003286	Symphony Graft Delivery System	Depuyacromed	2001	—
0 (this device)	K012738	Symphony Graft Delivery System (GDS)	Depuyacromed	2001	—
+1	K062365	Arthrex Aspirate Kit	Arthrex, Inc.	2006	—
+1	K121124	Arthrex Mixing and Delivery System	Arthrex, Inc.	2012	—
+2	K133021	Mixing Syringe System	Zimmer Knee Creations, Inc.	2014	—
+2	K141245	Etex Mixing and Delivery System	Etex Corporation	2014	—
+3	K161568	Bone Solutions Mixing and Delivery System	Bone Solutions, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2012	1	0
2014	3	0
2015	1	0
2016	3	0
2017	2	0
2018	3	0
2019	2	0
2020	7	0
2021	2	0
2022	2	0
2023	4	0
2024	4	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K012738, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003286	Symphony Graft Delivery System Summary page 1 …c. 325 Paramount Drive Raynham, MA 02780 NOV 14 2001 Karen F. Jurczak August 15, 2001 Piston Syringe Symphony Graft Delivery System Symphony Graft Delivery System (K003286, K010320) The Symphony Graft Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft mater…	Depuyacromed	2001	—
*	K010320	Modification to Symphony Graft Delivery System Summary page 1 …ramount Drive Raynham, MA 02780 NOV 14 2001 Karen F. Jurczak August 15, 2001 Piston Syringe Symphony Graft Delivery System Symphony Graft Delivery System (K003286, K010320) The Symphony Graft Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to a…	Depuyacromed	2001	—

Also cleared against K003286: 6 other devices →

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K062365	Arthrex Aspirate Kit	Arthrex, Inc.	2006	37
K121124	Arthrex Mixing and Delivery System	Arthrex, Inc.	2012	36

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, K062365 (Arthrex, Inc., 2006) has gone furthest, with 37 descendants of its own.
6 other devices also cite its predicate K003286.

How does its category compare?

All GEY devices

GEY Motor, Surgical Instrument, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEY

FDA has decided no GEY device since 2007.

Median 510(k) review, days · GEY

Too few GEY 510(k)s in any year since 2007 to give a median.

Recalls per year · GEY

2in 2013

2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEY

965in 2025

2007high 2,119 (2017) · low 4 (2009)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	19
2008	—	1	9
2009	—	1	4
2010	—	0	4
2011	—	0	11
2012	—	1	14
2013	—	2	901
2014	—	0	738
2015	—	0	2,013
2016	—	0	1,943
2017	—	0	2,119
2018	—	0	1,288
2019	—	0	1,131
2020	—	0	952
2021	—	0	1,145
2022	—	0	1,360
2023	—	0	1,444
2024	—	0	1,447
2025	—	0	965
2026	—	0	—

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 1.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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012738 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012738: Symphony Graft Delivery System (GDS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012738

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026