510(k) · Cleared
ClearedBone Solutions Mixing and Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bone Solutions, Inc. · FMF Syringe, Piston
Cleared on Sep 16, 2016 as substantially equivalent to K141245 (Etex Corporation, 2014) after a 101-day review. Its family tree reaches back 9 generations to 2002. 21 later devices descend from it.
- Decided
- Sep 16, 2016
- Review
- 101 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K013966 (2002). 26 ancestors in all, the oldest K994337 (2000). 21 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 5 generations between
- 3 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 2 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 1 generation backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- This deviceK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- Descendant · cites it directly · 11 of its ownK170675 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017
- Descendant · cites it directly · 7 of its ownK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- Descendant · 2 generations on · 6 of its ownK180937 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018
- Descendant · 2 generations on · 5 of its ownK182823 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- Descendant · 3 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 8 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 7 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 6 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 5 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 4 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 3 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 2 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 1 generation backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- This deviceK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017 · cites it directly11descendants
- K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · cites it directly7descendants
- K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018 · 2 generations on6descendants
- K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · 2 generations on5descendants
- K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −8 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −7 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −6 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −5 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −4 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −3 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −2 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| −1 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| 0 (this device) | K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016 | — |
| +1 | K170675 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2017 | — |
| +1 | K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| +2 | K180937 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2018 | — |
| +2 | K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| +3 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K141245 | Etex Mixing and Delivery SystemSummary page 4…Corporation th Address: 675 Massachusetts Ave., 12 Floor, Cambridge, MA 02139 510(k) number: K141245 Submitted Device Description The Bone Solutions Mixing and Delivery System is comprised of a commercially available disposable m… | 2014 |
What descends from it? (21)
See all 213 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 14 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K170675 (SurGenTec, LLC, 2017) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K141245.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Bone Solutions 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/K161568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161568: Bone Solutions 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/K161568
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