510(k) · Cleared

Recalled · 2007

Intergro DBM

K031399510(k) TraditionalCleared Feb 18, 2005655-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

Interpore Cross Intl. · MQV Filler, Bone Void, Calcium Compound

Cleared on Feb 18, 2005 after a 655-day review. The FDA summary names no predicate by number. 69 later devices descend from it. It has been recalled once.

Decided: Feb 18, 2005
Review: 655 days
Class: Class II
Product code: MQV
Recalls: 1
Predicates: 0

69 later devices descend from it, 6 citing it directly.

This deviceK031399 Intergro DBMInterpore Cross Intl. · 2005
Descendant · cites it directly · 34 of its ownK063050 Cap PlusEtex Corp. · 2007
Descendant · 2 generations on · 29 of its ownK080329 Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008
Descendant · 2 generations on · 28 of its ownK090310 EquivaboneEtex Corp. · 2009
Descendant · cites it directly · 28 of its ownK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
Descendant · 2 generations on · 25 of its ownK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

2005high 8 (2008) · low 0 (2026)2026

Most influential descendants

Showing 5 of 69 · See all

K063050Cap PlusEtex Corp. · 2007 · cites it directly34descendants
K080329Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008 · 2 generations on29descendants
K090310EquivaboneEtex Corp. · 2009 · 2 generations on28descendants
K040419Dynagraft IIIsotis Orthobiologics, Inc. · 2005 · cites it directly28descendants
K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009 · 2 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K031399	Intergro DBM	Interpore Cross Intl.	2005	—
+1	K063050	Cap Plus	Etex Corp.	2007	—
+2	K080329	Cap Plus, Equivabone, Cap/DBM	Etex Corp.	2008	—
+2	K090310	Equivabone	Etex Corp.	2009	—
+1	K040419	Dynagraft II	Isotis Orthobiologics, Inc.	2005	—
+2	K090855	Equivabone Osteoinductive Bone Graft Substitute	Etex Corp.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	4	0
2006	2	0
2007	3	0
2008	8	0
2009	5	0
2010	4	0
2011	5	0
2012	3	0
2013	4	0
2014	4	0
2015	4	0
2016	3	0
2017	2	0
2018	5	0
2019	1	0
2020	1	0
2021	2	0
2022	2	0
2023	3	0
2024	2	0
2025	2	0

FIG. 1 — Lineage of K031399, 2005–2025Source: 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

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (69)

See all 69

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

Number	Device	Applicant	Decided	Descendants
K063050	Cap Plus	Etex Corp.	2007	34
K040419	Dynagraft II	Isotis Orthobiologics, Inc.	2005	28
K050690	Connexus	Isotis Orthobiologics, Inc.	2005	6
K061880	Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC	Isotis NV	2007	5
K122868	Biosphere Bioactive Bone Graft Putty	Synergy Biomedical, LLC	2013	3
K051047	Colloss E Bone Void Filler	Ossacur AG	2006	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 15, 2007	Not classified	Z-0618-2008	Nonconforming Material/Component	Unapproved Testing:Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K063050 (Etex Corp., 2007) has gone furthest, with 34 descendants of its own.

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?

InterGro DBM products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The device may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm 2. The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031399 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031399: Intergro DBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031399

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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