510(k) · Cleared
ClearedTrugraft BGS Syringe, Model 600-041
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteobiologics, Inc. · FMF Syringe, Piston
Cleared on Jan 7, 2005 as substantially equivalent to K011087 (Orthovita, Inc., 2001) and 2 other predicates after a 52-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jan 7, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K994337 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| −1 | K032130 | Vitoss-Filled Cartridge | Orthovita, Inc. | 2003 | — |
| 0 (this device) | K043172 | Trugraft BGS Syringe, Model 600-041 | Osteobiologics, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K011087 | Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe | 2001 |
| * | K030208 | Imbibe II SyringeSummary page 1…ringe is substantially equivalent in) desien. function, and performance to the Imbibeim Bone Marrow Aspiration Syringe [KOI 1087] onl Sep 19, 2001, IMBIBE TM Il Syringe [K030208] and Vitoss®i-Filled Cartridge [K032 130]. 510(k) Prernarket Notification: TruGraftIm BGS Syringe… | 2003 |
| * | K032130 | Vitoss-Filled CartridgeSummary page 1…sien. function, and performance to the Imbibeim Bone Marrow Aspiration Syringe [KOI 1087] onl Sep 19, 2001, IMBIBE TM Il Syringe [K030208] and Vitoss®i-Filled Cartridge [K032 130]. 510(k) Prernarket Notification: TruGraftIm BGS Syringe 4 Confidential === Page 2… | 2003 |
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 5 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K011087.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
TruGraftTM BGS Syringe is indicated for the aspiration of fluids, such as autologous blood, plasma or other blood components with preloaded bone graft substitute.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043172 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043172: Trugraft BGS Syringe, Model 600-041.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043172
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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