510(k) · Cleared
ClearedGraftGun Universal Graft Delivery System (GDS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SurGenTec, LLC · FMF Syringe, Piston
Cleared on Feb 5, 2025 as substantially equivalent to K170675 (SurGenTec, LLC, 2017) and 1 other predicate after a 78-day review. Its family tree reaches back 12 generations to 2002. 1 later device descends from it.
- Decided
- Feb 5, 2025
- Review
- 78 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K013966 (2002). 30 ancestors in all, the oldest K994337 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 8 generations between
- 3 generations backK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- 2 generations backK170675 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017
- 1 generation backK180937 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018
- This deviceK243580 GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC · 2025
- Descendant · cites it directly · 0 of its ownK262581 GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
Show all 12 generations
- Root · 12 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 11 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 10 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 9 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 8 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 7 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 6 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 5 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 4 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 3 generations backK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- 2 generations backK170675 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017
- 1 generation backK180937 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018
- This deviceK243580 GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −11 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −10 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −9 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −8 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −7 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −6 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −5 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| −4 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| −3 | K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016 | — |
| −2 | K170675 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2017 | — |
| −1 | K180937 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2018 | — |
| 0 (this device) | K243580 | GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC | 2025 | — |
| +1 | K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170675 | Graftgun Universal Graft Delivery SystemSummary page 5…Piston / Syringe Classification: 21 CFR § 880.5860 Product Code: FMF Predicate Device: GraftGun Universal Delivery System (K170675) GraftGun Universal Delivery System (K180937) Device Description: The GraftGun Universal Graft Del… | 2017 |
| * | K180937 | Graftgun Universal Graft Delivery SystemSummary page 5…t Code: FMF Predicate Device: GraftGun Universal Delivery System (K170675) GraftGun Universal Delivery System (K180937) Device Description: The GraftGun Universal Graft Delivery System (GDS®) consists of a sterile, single-use, disposable device, a… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | 2026 | 0 |
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 23 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K262581 (SurGenTec, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K170675.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243580: GraftGun Universal 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/K243580
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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