510(k) · Cleared

Cleared

Osmosys Calcium Phosphate Ceramic Bone Filler

K050490510(k) TraditionalCleared Apr 11, 200545-day reviewClass II21 CFR 888.3045

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

Medicrea · MQV Filler, Bone Void, Calcium Compound

Cleared on Apr 11, 2005 as substantially equivalent to K030178 (Biomet, Inc., 2003) and 1 other predicate after a 45-day review. Its family tree reaches back 4 generations to 1996.

Decided: Apr 11, 2005
Review: 45 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K960978 (1996). 14 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
2 generations backK013960 Apatight HA-Bone Graft SubstituteCerabio, LLC · 2002
1 generation backK030178 Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003
This deviceK050490 Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K960978	Wright Plaster of Paris Pellets (Subject to Revision)	Wrightmedicaltechnologyinc	1996	—
−3	K980817	Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…	Interpore Intl.	1998	—
−2	K013960	Apatight HA-Bone Graft Substitute	Cerabio, LLC	2002	—
−1	K030178	Calcigen Psi Bone Graft Substitute	Biomet, Inc.	2003	—
0 (this device)	K050490	Osmosys Calcium Phosphate Ceramic Bone Filler	Medicrea	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2000	1	0
2001	1	0
2002	6	0

FIG. 1 — Lineage of K050490, 1996–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MQV? 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 MQV device

#1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 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? (2)

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	Applicant	Decided	Recalls
*	K030178	Calcigen Psi Bone Graft Substitute Summary page 1 …Filler, calciumr sulfite, preformed pellets Class II per 21 CFR section 888.3045 Product Code MQV Equivalent I)evice Calcigen (K030178) (Biomet - Warsaw, IN) Maslergrafi Resorbable Ceramic (K020986) (Medtronic Sofamor Danek -…	Biomet, Inc.	2003	—
*	K020986	Mastergraft Resorbable Ceramic Summary page 1 …R section 888.3045 Product Code MQV Equivalent I)evice Calcigen (K030178) (Biomet - Warsaw, IN) Maslergrafi Resorbable Ceramic (K020986) (Medtronic Sofamor Danek - Memphis.TN ). I)evice l)escription OSMOSYS is a synthetic bone substitute co…	Medtronic Sofamor Danek, Inc.	2002	—

Also cleared against K030178: 1 other device →

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 5 companies; a new generation was cleared every 2.3 years on median.
None of the 14 ancestors has a recall.
1 other device also cites its predicate K030178.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQV

14in 2025

2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007high 214 (2016) · low 55 (2024)2026

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

Recalls per year · MQV

1in 2025

2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQV

57in 2025

2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, 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	35	144	5	67
2008	32	102	3	71
2009	23	180	1	81
2010	17	147	0	68
2011	16	92	6	114
2012	9	107	3	149
2013	12	197	2	223
2014	20	153	0	111
2015	18	184	0	125
2016	8	214	1	106
2017	17	124	1	107
2018	23	124	2	86
2019	13	90	0	65
2020	15	132	1	126
2021	8	88	0	101
2022	9	118	0	47
2023	21	74	3	120
2024	28	55	2	68
2025	14	57	1	57
2026	5	96	4	—

What is it indicated for?

OSMOSYS is intended for use as a bone void filler to fill bony void gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. OSMOSYS is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Following placement in the bony voids or gap, OSMOSYS resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050490 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050490: Osmosys Calcium Phosphate Ceramic Bone Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050490

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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