510(k) · Cleared
ClearedAllograft Delivery Device (OFAC-C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioventus, LLC · FMF Syringe, Piston
Cleared on Jun 25, 2024 as substantially equivalent to K142661 (Spinal Surgical Strategies, LLC, 2014) after a 267-day review. Its family tree reaches back 8 generations to 2002.
- Decided
- Jun 25, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K013966 (2002). 19 ancestors in all, the oldest K994337 (2000). No later device cites it as a predicate yet.
- 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 backK142661 Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC · 2014
- This deviceK233368 Allograft Delivery Device (OFAC-C)Bioventus, LLC · 2024
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 | K142661 | Bi-Portal Bone Graft Delivery Device | Spinal Surgical Strategies, LLC | 2014 | — |
| 0 (this device) | K233368 | Allograft Delivery Device (OFAC-C) | Bioventus, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K142661 | Bi-Portal Bone Graft Delivery DeviceSummary page 4…Delivery Canula) Manufacturer: Spinal Surgical Strategies, LLC (Kleiner Device Labs) 510(k): K142661 Page 1 of 5 Device Descri… | 2014 |
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 22 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 3 other devices also cite its predicate K142661.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Allograft Delivery Device is intended to be used for the delivery of hydrated allograft to an orthopedic surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233368 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233368: Allograft Delivery Device (OFAC-C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233368
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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