510(k) · Cleared

Recalled · Class II · 2013

Osteoselect Demineralized Bone Matrix Putty

K091321510(k) TraditionalCleared Sep 11, 2009129-day reviewClass II21 CFR 888.3045Recalls 2

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

Bacterin International, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Sep 11, 2009 as substantially equivalent to K040262 (Musculoskeletal Transplant Foundation, 2005) and 1 other predicate after a 129-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it. It has been recalled 2 times.

Decided: Sep 11, 2009
Review: 129 days
Class: Class II
Product code: MQV
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K040262 (2005). 2 ancestors in all. 2 later devices descend from it, 2 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 deviceK091321 Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 2009
Descendant · cites it directly · 1 of its ownK130498 Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 2013 · Recalled
Descendant · cites it directly · 0 of its ownK150621 OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K130498Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 2013 · cites it directly1descendant
K150621OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc. · 2015 · cites it directly0descendants

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)	K091321	Osteoselect Demineralized Bone Matrix Putty	Bacterin International, Inc.	2009	—
+1	K130498	Osteoselect Demineralized Bone Matrix Putty	Bacterin International, Inc.	2013	1
+1	K150621	OsteoSelect PLUS Demineralized Bone Matrix Putty	Bacterin International, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0

FIG. 1 — Lineage of K091321, 2005–2015Source: 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
*	K040262	DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix Summary page 1 …11 Predicate Devices DBXO Demineralized Bone Matrix Putty Musculoskeletal Transplant Foundation 51 0(k) K040262 Grafton® DBM Osteotech, Inc. 51 0(k) K051195 Description OsteoSel…	Musculoskeletal Transplant Foundation	2005	2
*	K051195	Grafton DBM Summary page 1 …loskeletal Transplant Foundation 51 0(k) K040262 Grafton® DBM Osteotech, Inc. 51 0(k) K051195 Description OsteoSeleCtTm Demineralized Bone Matrix Putty is processed human bone that has been demineralized and combined with…	Osteotech, Inc.	2005	30

Also cleared against K040262: 12 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
K130498	Osteoselect Demineralized Bone Matrix Putty	Bacterin International, Inc.	2013	1
K150621	OsteoSelect PLUS Demineralized Bone Matrix Putty	Bacterin International, Inc.	2015	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 21, 2013	Class II	Z-1138-2013	Process control	The firm's retesting procedure was not validated.
Apr 18, 2012	Class II	Z-0800-2013	Incorrect or no expiration date	Expired product was shipped to two customers.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K130498 (Bacterin International, Inc., 2013) 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. 2009, 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?

OsteoSelectTM (DBM) Putty is indicated for use as a bone'void filler and bone graft substitute for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of bony structure. It is indicated for treatment of surgically created Osseous defects or osseous defects from traumatic injury to the bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091321 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091321: Osteoselect Demineralized Bone Matrix Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091321

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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