510(k) · Cleared

Recalled · 2011

MBCP+

K063527510(k) TraditionalCleared Jul 30, 2007250-day reviewClass II21 CFR 888.3045Recalls 1

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

Biomatlante · MQV Filler, Bone Void, Calcium Compound

Cleared on Jul 30, 2007 as substantially equivalent to K040514 (Ortho Tec, LLC, 2004) and 1 other predicate after a 250-day review. Its family tree reaches back 3 generations to 1997. It has been recalled once.

Decided: Jul 30, 2007
Review: 250 days
Class: Class II
Product code: MQV
Recalls: 1
Predicates: 2

Its longest line of descent runs back 3 generations to K963587 (1997). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK963587 Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc · 1997
2 generations backK991854 Osteoplast, Model POP200Interpore Cross Intl. · 1999
1 generation backK033258 Bonesave Bone Void FillerHowmedica Osteonics · 2004
This deviceK063527 MBCP+Biomatlante · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K963587	Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)	Wrightmedicaltechnologyinc	1997	—
−2	K991854	Osteoplast, Model POP200	Interpore Cross Intl.	1999	—
−1	K033258	Bonesave Bone Void Filler	Howmedica Osteonics	2004	—
0 (this device)	K063527	MBCP+	Biomatlante	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2002	1	0
2004	1	0

FIG. 1 — Lineage of K063527, 1997–2007Source: 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
*	K040514	Eovia Calcium Phosphate Ceramic Summary page 1 …888.3045 2. PREDICATE DEVICES Product Code Manufacturer 510(k) Product MQV ______ Orthotec K040514 EOVIA MQV Howmedica Osteonics K033258 BONESAVE 3. DEVICE DE…	Ortho Tec, LLC	2004	—
*	K033258	Bonesave Bone Void Filler Summary page 1 …510(k) Product MQV ______ Orthotec K040514 EOVIA MQV Howmedica Osteonics K033258 BONESAVE 3. DEVICE DESCRIPTION MBCP+TM is a non structural bone graft substitute, which is resorbable…	Howmedica Osteonics	2004	—

Also cleared against K040514: 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 31, 2011	Not classified	Z-1677-2011	Other	The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
None of the 7 ancestors has a recall.
2 other devices also cite its predicate K040514.

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. 2007, this device’s year, is highlighted.

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?

MBCP+ TM is intended for use as bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP+Tm is provided sterile for single patient use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063527 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063527: MBCP+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063527

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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