510(k) · Cleared
ClearedGPS Advanced; GPS Advanced Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosidyan, Inc. · FMF Syringe, Piston
Cleared on Jun 24, 2025 as substantially equivalent to K241426 (Prosidyan, Inc., 2024) after a 26-day review. Its family tree reaches back 14 generations to 2002.
- Decided
- Jun 24, 2025
- Review
- 26 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K013966 (2002). 32 ancestors in all, the oldest K994337 (2000). No later device cites it as a predicate yet.
- Root · 14 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 10 generations between
- 3 generations backK180937 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018
- 2 generations backK201338 Allograft MIS Delivery SystemLifenet Health · 2020
- 1 generation backK241426 GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc. · 2024
- This deviceK251648 GPS Advanced; GPS Advanced CannulaProsidyan, Inc. · 2025
Show all 14 generations
- Root · 14 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 13 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 12 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 11 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 10 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 9 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 8 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 7 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 6 generations backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- 5 generations backK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- 4 generations backK170675 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017
- 3 generations backK180937 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018
- 2 generations backK201338 Allograft MIS Delivery SystemLifenet Health · 2020
- 1 generation backK241426 GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc. · 2024
- This deviceK251648 GPS Advanced; GPS Advanced CannulaProsidyan, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −13 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −12 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −11 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −10 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −9 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −8 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −7 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| −6 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| −5 | K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016 | — |
| −4 | K170675 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2017 | — |
| −3 | K180937 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2018 | — |
| −2 | K201338 | Allograft MIS Delivery System | Lifenet Health | 2020 | — |
| −1 | K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | Prosidyan, Inc. | 2024 | — |
| 0 (this device) | K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | 2025 | — |
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 |
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 16.1 · 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? (1)
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 |
|---|---|---|---|
| * | K241426 | GPS Advanced; 5 cc GPS Advanced CannulaSummary page 5…Code: FMF – General Hospital & Personal Use D. Predicate Device Names Primary Predicate Device: GPS Advanced and GPS Advanced Cannula (K241426), FMF Reference Device: Allograft MIS Delivery System (K201338), FMF E. Device Description GPS Advan… | 2024 |
| † | K201338 | Allograft MIS Delivery System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 32 ancestors have a recall of any class.
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?
GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251648 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251648: GPS Advanced; GPS Advanced Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251648
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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