510(k) · Cleared
ClearedInstaFill Graft Delivery System, SIGNIFY Bioactive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · FMF Syringe, Piston
Cleared on Aug 11, 2022 as substantially equivalent to K180937 (SurGenTec, LLC, 2018) and 2 other predicates after a 57-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Aug 11, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K960978 (1996). 85 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 12 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 8 generations between
- 3 generations backK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- 2 generations backK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
- 1 generation backK130977 Signify BioactiveGlobus Medical, Inc. · 2013
- This deviceK221737 InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 11 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 10 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 9 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 8 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 7 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 6 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 5 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 4 generations backK093447 CarrigenEtex Corp. · 2010
- 3 generations backK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- 2 generations backK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
- 1 generation backK130977 Signify BioactiveGlobus Medical, Inc. · 2013
- This deviceK221737 InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −11 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −10 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −9 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −8 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −7 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −6 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −5 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| −4 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| −3 | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
| −2 | K130392 | Kinex Bioactive | Globus Medical, Inc. | 2013 | — |
| −1 | K130977 | Signify Bioactive | Globus Medical, Inc. | 2013 | — |
| 0 (this device) | K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | Globus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K180937 | Graftgun Universal Graft Delivery SystemSummary page 4…Product Code: FMF Regulatory Class: II, Panel Code: 80 & 87 Predicates: Primary Graftgun Universal Graft Delivery System (K180937) Additional Graftgun Universal Graft Delivery System (K170675) SIGNIFY® Bioactive (K130977) Purpose… | 2018 |
| * | K170675 | Graftgun Universal Graft Delivery SystemSummary page 4…II, Panel Code: 80 & 87 Predicates: Primary Graftgun Universal Graft Delivery System (K180937) Additional Graftgun Universal Graft Delivery System (K170675) SIGNIFY® Bioactive (K130977) Purpose: The purpose of this submission is to request clearance for the InstaF… | 2017 |
| * | K130977 | Signify BioactiveSummary page 4…Graftgun Universal Graft Delivery System (K180937) Additional Graftgun Universal Graft Delivery System (K170675) SIGNIFY® Bioactive (K130977) Purpose: The purpose of this submission is to request clearance for the InstaFill™ Graft Delivery System and cartridges pre-fil… | 2013 |
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 26 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 85 ancestors have a recall of any class.
- 3 other devices also cite its predicate K180937.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 InstaFillm Graft Delivery System is intended to be used for the delivery of allograft, autograft, or synthetic bone
graft material to an orthopedic surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221737: InstaFill Graft Delivery System, SIGNIFY Bioactive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221737
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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