510(k) · Cleared

Cleared

DBX Demineralized Bone Matrix Putty/Paste/Mix

K053218510(k) TraditionalCleared Dec 28, 2006406-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

Musculoskeletal Transplant Foundation · MQV Filler, Bone Void, Calcium Compound

Cleared on Dec 28, 2006 as substantially equivalent to K040262 (Musculoskeletal Transplant Foundation, 2005) after a 406-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.

Decided: Dec 28, 2006
Review: 406 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K040262 (2005). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK040262 DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone…Musculoskeletal Transplant Foundation · 2005 · Recalled
This deviceK053218 DBX Demineralized Bone Matrix Putty/Paste/MixMusculoskeletal Transplant Foundation · 2006
Descendant · cites it directly · 1 of its ownK121989 Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC)…Exactech, Inc. · 2012
Descendant · 2 generations on · 0 of its ownK241555 Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025

Most influential descendants

Showing 2 of 2 · See all

K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc. · 2012 · cites it directly1descendant
K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K040262	DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix	Musculoskeletal Transplant Foundation	2005	2
0 (this device)	K053218	DBX Demineralized Bone Matrix Putty/Paste/Mix	Musculoskeletal Transplant Foundation	2006	—
+1	K121989	Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure +…	Exactech, Inc.	2012	—
+2	K241555	Moldable Bone Void Filler and Moldable Bone Void Filler + CCC	Rti Surgical, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2025	1	0

FIG. 1 — Lineage of K053218, 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? (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
*	K040262	DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix Summary page 2 …Putty, using in vitro testing as an alternative for in vivo testing for osteoinductivity, is the same as the technology for the unmodified predicate, DBX® (FDA cleared, K040262). Biocompatibility of DBX® materials has been established through their long history of safe and effective clinical use, further…	Musculoskeletal Transplant Foundation	2005	2

Also cleared against K040262: 12 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121989	Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…	Exactech, Inc.	2012	1

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 a recall.
Of its descendants, K121989 (Exactech, Inc., 2012) has gone furthest, with 1 descendant of its own.
12 other devices also cite its predicate K040262.

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?

DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the:

Paste and Mix: Extremities, Pelvis

Putty: Extremities, Pelvis, Posterolateral spine, Cranium

DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autografi. DBX® can be used with bone marrow.

DBX® is for single patient use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053218 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053218: DBX Demineralized Bone Matrix Putty/Paste/Mix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053218

Report an extraction error

Are you the manufacturer?

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