510(k) · Cleared

Cleared

Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901, Ossaplast Ortho, 3.0ML, Model# 221 903

K042305510(k) AbbreviatedCleared Oct 21, 200457-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

Ossacur AG · MQV Filler, Bone Void, Calcium Compound

Cleared on Oct 21, 2004 as substantially equivalent to K014156 (Curasan AG, 2002) after a 57-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.

Decided: Oct 21, 2004
Review: 57 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K014156 (2002). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK014156 Cerasorb OrthoCurasan AG · 2002
This deviceK042305 Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML…Ossacur AG · 2004
Descendant · cites it directly · 1 of its ownK050416 Ossaplast OrthoOssacur AG · 2005
Descendant · cites it directly · 0 of its ownK051047 Colloss E Bone Void FillerOssacur AG · 2006

Most influential descendants

Showing 2 of 2 · See all

K050416Ossaplast OrthoOssacur AG · 2005 · cites it directly1descendant
K051047Colloss E Bone Void FillerOssacur AG · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K014156	Cerasorb Ortho	Curasan AG	2002	—
0 (this device)	K042305	Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221…	Ossacur AG	2004	—
+1	K050416	Ossaplast Ortho	Ossacur AG	2005	—
+1	K051047	Colloss E Bone Void Filler	Ossacur AG	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0

FIG. 1 — Lineage of K042305, 2002–2006Source: 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? (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	Applicant	Decided	Recalls
*	K014156	Cerasorb Ortho Summary page 1 …d filler device, §888.3045 (Product Code: MOV) C. Predicate Device Trade Name: Cerasorb® ORTIHO (K0141 56) D. Device Description OSSAPLAST ORTHO is a synthetic, implantable, resorbable, radiopaque f3-trical…	Curasan AG	2002	—

Also cleared against K014156: 7 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K050416	Ossaplast Ortho	Ossacur AG	2005	1
K051047	Colloss E Bone Void Filler	Ossacur AG	2006	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?

Its one ancestor has no recall.
Of its descendants, K050416 (Ossacur AG, 2005) has gone furthest, with 1 descendant of its own.
7 other devices also cite its predicate K014156.

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?

OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042305 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042305: Ossaplast Ortho, O.5ML, Model# 221 900, Ossaplast Ortho, 1.0ML, Model# 221 901, Ossaplast Ortho, 3.0ML, Model# 221 903.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042305

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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