510(k) · Cleared
ClearedCoaxial Applicator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · FMF Syringe, Piston
Cleared on Mar 12, 2010 as substantially equivalent to K011032 (Harvest Technologies, Corp., 2001) and 2 other predicates after a 274-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Mar 12, 2010
- Review
- 274 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K011032 (2001). 3 ancestors in all, the oldest K883338 (1988). No later device cites it as a predicate yet.
- Root · 2 generations backK011032 Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S…Harvest Technologies, Corp. · 2001
- 1 generation backK020252 Smartjet Grafting Liquid Applicator, Models SK/S & LK/2Harvest Technologies, Corp. · 2002
- This deviceK091722 Coaxial Applicator SystemBiomet, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone… | Harvest Technologies, Corp. | 2001 | — |
| −1 | K020252 | Smartjet Grafting Liquid Applicator, Models SK/S & LK/2 | Harvest Technologies, Corp. | 2002 | — |
| 0 (this device) | K091722 | Coaxial Applicator System | Biomet, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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? (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 |
|---|---|---|---|
| * | K011032 | Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone Graft… | 2001 |
| * | K020252 | Smartjet Grafting Liquid Applicator, Models SK/S & LK/2Summary page 1…___ ____ ____ ____ ___ ____ ___ Plymouth, MA 02360 K020252 SmartJetTm Liquid Grafting Applicator Harvest Technologies… | 2002 |
| * | K883338 | Surgical Sealant ApplicatorSummary page 1…Harvest Technologies Corp. _ __ __ _ __ __ __ _ __ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ P y mo th, MA 2 3 6 0 _K883338 Surgical Sealant Applicator (Fibriiet®) Micromedics, Inc.… | 1988 |
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 9 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K011032.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 CoAxial Applicator System is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials for application to an orthopedic surgical site,,with autologous blood, plasma, platelet-rich plasma, or other specific blood component(s) as deemed necessary by the clinical use requirements. In addition, the CoAxial Applicator System is intended for the application of autologous blood, plasma, platelet-rich plasma, or other…
Read the full statement (99 words)
The CoAxial Applicator System is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials for application to an orthopedic surgical site,,with autologous blood, plasma, platelet-rich plasma, or other specific blood component(s) as deemed necessary by the clinical use requirements.
In addition, the CoAxial Applicator System is intended for the application of autologous blood, plasma, platelet-rich plasma, or other specific blood component(s), as deemed necessary by the surgeon's determination of the clinical use requirements to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091722: Coaxial Applicator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091722
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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