510(k) · Cleared

Cleared

Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe

K011087510(k) TraditionalCleared Sep 19, 2001162-day reviewClass II21 CFR 880.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Sep 19, 2001 after a 162-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.

Decided: Sep 19, 2001
Review: 162 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 0

40 later devices descend from it, 3 citing it directly.

This deviceK011087 Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration SyringeOrthovita, Inc. · 2001
Descendant · cites it directly · 38 of its ownK023074 Imbibe Bone Marrow Aspiration SyringeOrthovita, Inc. · 2003
Descendant · cites it directly · 37 of its ownK062986 Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006
Descendant · 2 generations on · 36 of its ownK121124 Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012
Descendant · 3 generations on · 32 of its ownK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
Descendant · 3 generations on · 31 of its ownK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2003high 7 (2020) · low 0 (2004)2026

Most influential descendants

Showing 5 of 40 · See all

K023074Imbibe Bone Marrow Aspiration SyringeOrthovita, Inc. · 2003 · cites it directly38descendants
K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006 · cites it directly37descendants
K121124Arthrex Mixing and Delivery SystemArthrex, Inc. · 2012 · 2 generations on36descendants
K133021Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014 · 3 generations on32descendants
K141245Etex Mixing and Delivery SystemEtex Corporation · 2014 · 3 generations on31descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011087	Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe	Orthovita, Inc.	2001	—
+1	K023074	Imbibe Bone Marrow Aspiration Syringe	Orthovita, Inc.	2003	—
+1	K062986	Medtronic Graft Delivery Syringe	Medtronic Sofamor Danek USA, Inc.	2006	—
+2	K121124	Arthrex Mixing and Delivery System	Arthrex, Inc.	2012	—
+3	K133021	Mixing Syringe System	Zimmer Knee Creations, Inc.	2014	—
+3	K141245	Etex Mixing and Delivery System	Etex Corporation	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	1	0
2012	1	0
2014	3	0
2015	1	0
2016	3	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

FIG. 1 — Lineage of K011087, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (40)

See all 40

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023074	Imbibe Bone Marrow Aspiration Syringe	Orthovita, Inc.	2003	38
K062986	Medtronic Graft Delivery Syringe	Medtronic Sofamor Danek USA, Inc.	2006	37
K043172	Trugraft BGS Syringe, Model 600-041	Osteobiologics, Inc.	2005	0

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?

Of its descendants, K023074 (Orthovita, Inc., 2003) has gone furthest, with 38 descendants of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007high 5,874 (2021) · low 186 (2011)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)	—

https://510kreport.com/device/K011087 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011087: Orthovita Piston Syringe or Imbibe Bone Marrow Aspiration Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011087

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026