510(k) · Cleared
ClearedEtex Mixing and Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etex Corporation · FMF Syringe, Piston
Cleared on Jul 9, 2014 as substantially equivalent to K133021 (Zimmer Knee Creations, Inc., 2014) and 1 other predicate after a 56-day review. Its family tree reaches back 8 generations to 2002. 31 later devices descend from it.
- Decided
- Jul 9, 2014
- Review
- 56 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K013966 (2002). 25 ancestors in all, the oldest K994337 (2000). 31 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 7 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 6 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 5 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 4 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 3 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 2 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 1 generation backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- This deviceK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- Descendant · cites it directly · 21 of its ownK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- Descendant · 2 generations on · 11 of its ownK170675 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017
- Descendant · cites it directly · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 7 of its ownK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- Descendant · 3 generations on · 6 of its ownK180937 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016 · cites it directly21descendants
- K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017 · 2 generations on11descendants
- K161447HydroSet XTOrthovita, Inc. · 2016 · cites it directly10descendants
- K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · 2 generations on7descendants
- K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −7 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −6 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −5 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −4 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −3 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −2 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −1 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| 0 (this device) | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| +1 | K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016 | — |
| +2 | K170675 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2017 | — |
| +1 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
| +2 | K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| +3 | K180937 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 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 |
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? (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 |
|---|---|---|---|
| * | K133021 | Mixing Syringe SystemSummary page 2…d Delivery System has the same indications for use, design, function, materials, and is substantially equivalent to the Zimmer Knee Creations Inc. Mixing Syringe System (K1 33021) and the Arthrex Mixing and Delivery System (K121 124) Performance Standards: All necessary testing has been performed for the… | 2014 |
| * | K121124 | Arthrex Mixing and Delivery SystemSummary page 2…sign, function, materials, and is substantially equivalent to the Zimmer Knee Creations Inc. Mixing Syringe System (K1 33021) and the Arthrex Mixing and Delivery System (K121 124) Performance Standards: All necessary testing has been performed for the ETEX Mixing and Delivery System to assure substantial… | 2012 |
What descends from it? (31)
See all 313 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K161568 (Bone Solutions, Inc., 2016) has gone furthest, with 21 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ETEX Mixing and Delivery System is intended to be used for the delivery of hydrated 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/K141245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141245: Etex Mixing and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141245
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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