510(k) · Cleared

Cleared

Osteomimetic Synthetic Bone Matrix

K051775510(k) TraditionalCleared Sep 6, 200567-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

Biomimetic Pharmaceuticals, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Sep 6, 2005 as substantially equivalent to K014053 (Depuyacromed, 2002) and 2 other predicates after a 67-day review. Its family tree reaches back 2 generations to 1999.

Decided: Sep 6, 2005
Review: 67 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K990131 (1999). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
1 generation backK014053 Conduit TCP GranulesDepuyacromed · 2002
This deviceK051775 Osteomimetic Synthetic Bone MatrixBiomimetic Pharmaceuticals, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990131	Pro Osteon Implant 500R Resorbable Bone Graft Substitute	Interpore Cross Intl.	1999	—
−1	K014053	Conduit TCP Granules	Depuyacromed	2002	—
0 (this device)	K051775	Osteomimetic Synthetic Bone Matrix	Biomimetic Pharmaceuticals, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0

FIG. 1 — Lineage of K051775, 1999–2005Source: 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? (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	Applicant	Decided	Recalls
*	K014053	Conduit TCP Granules Summary page 1 …salt bone void filler device CLASSIFICATION: Class II; 21 CFR 888.3045 (ProCode MQV) PREDICATE DEVICE: Depuy ConduitTM TCP Granules, K014053 Synthes chronOS, K013072 OrthoVita VitOssTM Scaffold Synthe…	Depuyacromed	2002	—
*	K013072	Chronos Tricalcium Prosphate (Chronos TCP) Summary page 1 …Class II; 21 CFR 888.3045 (ProCode MQV) PREDICATE DEVICE: Depuy ConduitTM TCP Granules, K014053 Synthes chronOS, K013072 OrthoVita VitOssTM Scaffold Synthetic Cancellous Bone Void…	Synthes	2002	—
*	K994337	Vitoss Scaffold Synthetic Cancellous Bone Void Filler Summary page 1 …Synthes chronOS, K013072 OrthoVita VitOssTM Scaffold Synthetic Cancellous Bone Void Filler, K994337 DEVICE DESCRIPTION: OsteoMimetic Synthetic Bone Matrix is a synthetic, multicry…	Orthovita Co.	2000	—

Also cleared against K014053: 2 other devices →

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 6 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K014053.

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?

OsteoMimetic™ Synthetic Bone Matrix is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. The OsteoMimetic matrix is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone in conjunction with standard measures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051775 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051775: Osteomimetic Synthetic Bone Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051775

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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