510(k) · Cleared
Cleared3D GraftRasp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgentec · FMF Syringe, Piston
Cleared on Sep 3, 2020 as substantially equivalent to K200431 (Surgentec, 2020) after a 57-day review. Its family tree reaches back 12 generations to 2002.
- Decided
- Sep 3, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K013966 (2002). 30 ancestors in all, the oldest K994337 (2000). No later device cites it as a predicate yet.
- 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 backK200431 3D GraftRasp SystemSurgentec · 2020
- This deviceK201900 3D GraftRasp SystemSurgentec · 2020
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 backK200431 3D GraftRasp SystemSurgentec · 2020
- This deviceK201900 3D GraftRasp SystemSurgentec · 2020
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 | K200431 | 3D GraftRasp System | Surgentec | 2020 | — |
| 0 (this device) | K201900 | 3D GraftRasp System | Surgentec | 2020 | — |
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 16.2 · 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? (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 |
|---|---|---|---|
| * | K200431 | 3D GraftRasp SystemSummary page 4…rketed Predicate Device Predicate: 3D GraftRasp System Surgentec, LLC. Class II Device (K200431) 5.4 Device Description The 3D GraftRasp system contains various decortication rasps, graf… | 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 18 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 30 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. 2020, 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 3D GraftRasp System is intended to be used in orthopedic procedures to rasp or decorticate bone from the transverse processes and/or facets, and for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
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/K201900 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201900: 3D GraftRasp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201900
Report an extraction error
Are you the manufacturer?
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