510(k) · Cleared

Cleared

Mastergraft Strip

K082166510(k) TraditionalCleared Jun 2, 2009306-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

Medtronic Sofamor Danek · MQV Filler, Bone Void, Calcium Compound

Cleared on Jun 2, 2009 as substantially equivalent to K023553 (Medtronic Sofamor Danek, Inc., 2003) and 4 other predicates after a 306-day review. Its family tree reaches back 7 generations to 1996. 38 later devices descend from it.

Decided: Jun 2, 2009
Review: 306 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 5

Its longest line of descent runs back 7 generations to K960978 (1996). 32 ancestors in all, the oldest K871773 (1987). 38 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
5 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
4 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
3 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
2 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
1 generation backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
This deviceK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
Descendant · cites it directly · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
Descendant · 2 generations on · 6 of its ownK181225 AltaporeBaxter Healthcare Corporation · 2018
Descendant · 2 generations on · 4 of its ownK193075 Osteo3 ZP PuttySirakoss, Ltd. · 2020
Descendant · 2 generations on · 4 of its ownK192363 AltaporeBaxter Healthcare Corporation · 2020
Descendant · 3 generations on · 3 of its ownK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2011high 7 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 38 · See all

K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · cites it directly30descendants
K181225AltaporeBaxter Healthcare Corporation · 2018 · 2 generations on6descendants
K193075Osteo3 ZP PuttySirakoss, Ltd. · 2020 · 2 generations on4descendants
K192363AltaporeBaxter Healthcare Corporation · 2020 · 2 generations on4descendants
K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K960978	Wright Plaster of Paris Pellets (Subject to Revision)	Wrightmedicaltechnologyinc	1996	—
−6	K980817	Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…	Interpore Intl.	1998	—
−5	K000515	Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101…	Interpore Cross Intl.	2000	—
−4	K012751	Healos Bone Graft Material	Orquest, Inc.	2001	—
−3	K043308	Modification to: Healos Bone Graft Material	Depuy Spine, Inc.	2005	—
−2	K051386	Mastergraft Putty Bone Void Filler	Medtronic Vascular	2005	—
−1	K071813	Mastergraft Putty	Medtronic Sofamor Danek	2007	—
0 (this device)	K082166	Mastergraft Strip	Medtronic Sofamor Danek	2009	—
+1	K140375	Mastergraft Putty, Mastergraft Strip	Medtronic Sofamor Danek USA, Inc.	2014	—
+2	K181225	Altapore	Baxter Healthcare Corporation	2018	—
+2	K193075	Osteo3 ZP Putty	Sirakoss, Ltd.	2020	—
+2	K192363	Altapore	Baxter Healthcare Corporation	2020	—
+3	K211201	MagnetOs Easypack Putty	Kuros Biosciences B.V	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1992	1	0
1995	2	0
1997	1	0
1998	2	0
1999	1	0
2000	2	0
2001	2	0
2002	3	0
2003	3	0
2004	2	0
2005	2	0
2006	2	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0
2014	3	0
2015	1	0
2017	1	0
2018	3	0
2019	3	0
2020	4	0
2021	1	0
2022	5	0
2023	6	0
2024	7	0
2025	2	0

FIG. 1 — Lineage of K082166, 1996–2025Source: 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? (5)

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
*	K023553	Mastergraft Matrix Summary page 2 …S2 MASTERGRAFT Strip K082 166 predicates, MASTERGRAFT® Matrix (K023553, SE 0412212003, bone void filler) and MASTERGRAFT® Putty (K071813, SE 11/09/07, autograft extender), the subject syst…	Medtronic Sofamor Danek, Inc.	2003	—
*	K071813	Mastergraft Putty Summary page 2 …K082 166 predicates, MASTERGRAFT® Matrix (K023553, SE 0412212003, bone void filler) and MASTERGRAFT® Putty (K071813, SE 11/09/07, autograft extender), the subject system is intended to be combined with autogenous bone marrow as a bon…	Medtronic Sofamor Danek	2007	—
*	K052812	Ossimend (TM) Bone Graft Material Summary page 2 …rip to be substantially equivalent to the previously cleared MASTERGRAFT® Matrix (K023553), MASTERGRAFT® Putty (K071813), OssiMend Bone Graft Material (K052812), Collagraft Strip Bone Graft Material (K000122) and Integra MOZAIK T M Osteoconductive Scaffold - Strip (K063124). MAS…	Collagen Matrix, Inc.	2006	—
*	K000122	Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6… Summary page 2 …previously cleared MASTERGRAFT® Matrix (K023553), MASTERGRAFT® Putty (K071813), OssiMend Bone Graft Material (K052812), Collagraft Strip Bone Graft Material (K000122) and Integra MOZAIK T M Osteoconductive Scaffold - Strip (K063124). MASTERGRAFT Strip…	Neucoll, Inc.	2001	—
*	K063124	Integra Mozaik Bone Regeneration Matrix - Strips Summary page 2 …ty (K071813), OssiMend Bone Graft Material (K052812), Collagraft Strip Bone Graft Material (K000122) and Integra MOZAIK T M Osteoconductive Scaffold - Strip (K063124). MASTERGRAFT Strip K082166 DEPARTMENT OF HEA…	Integra Lifesciences Corp.	2007	1

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K140375	Mastergraft Putty, Mastergraft Strip	Medtronic Sofamor Danek USA, Inc.	2014	30
K130335	Mastergraft Strip; Mastergraft Ultramatrix	Medtronic Sofamor Danek USA, Inc.	2013	2
K111944	NB3D Bone Void Filler	Pioneer Surgical Technology, Inc.	2011	1
K221726	Uni-FuZe-C Bone Strip	Zavation Medical Products, LLC	2023	0
K213959	MagnetOs Flex Matrix	Kuros Biosciences B.V	2022	0
K191074	Sorrento Bone Graft Substitute	Xenco Medical, LLC	2019	0
K151172	MASTERGRAFT Contain	Medtronic Sofamor Danek USA, Inc.	2015	0

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 13 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
3 of the 32 ancestors have a recall of any class.
Of its descendants, K140375 (Medtronic Sofamor Danek USA, Inc., 2014) has gone furthest, with 30 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. 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?

MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082166 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082166: Mastergraft Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082166

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