510(k) · Cleared

Recalled · Class II · 2011

Mozaik Bone Regeneration Matrix - Putty

K062353510(k) TraditionalCleared Dec 20, 2006131-day reviewClass II21 CFR 888.3045Recalls 3

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

Integra LifeSciences Corporation · MQV Filler, Bone Void, Calcium Compound

Cleared on Dec 20, 2006 as substantially equivalent to K032288 (Orthovita, Inc., 2003) after a 131-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it. It has been recalled 3 times.

Decided: Dec 20, 2006
Review: 131 days
Class: Class II
Product code: MQV
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K032288 (2003). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK032288 Vitoss Scaffold Foam Bone Graft MaterialOrthovita, Inc. · 2003
This deviceK062353 Mozaik Bone Regeneration Matrix - PuttyIntegra LifeSciences Corporation · 2006
Descendant · cites it directly · 0 of its ownK231030 Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 2023
Descendant · cites it directly · 0 of its ownK091302 Integra Mozaik and OS Moldable MorselsIntegra LifeSciences Corporation · 2009

Most influential descendants

Showing 2 of 2 · See all

K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 2023 · cites it directly0descendants
K091302Integra Mozaik and OS Moldable MorselsIntegra LifeSciences Corporation · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032288	Vitoss Scaffold Foam Bone Graft Material	Orthovita, Inc.	2003	—
0 (this device)	K062353	Mozaik Bone Regeneration Matrix - Putty	Integra LifeSciences Corporation	2006	—
+1	K231030	Cove Putty, OsteoCove Putty	SeaSpine Orthopedics Corporation	2023	—
+1	K091302	Integra Mozaik and OS Moldable Morsels	Integra LifeSciences Corporation	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2023	1	0

FIG. 1 — Lineage of K062353, 2003–2023Source: 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? (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
*	K032288	Vitoss Scaffold Foam Bone Graft Material Summary page 1 …equivalent in function and intended use to VITOSS10 Scaffold Foam Bone Graft Matrix which has been cleared to market under Premnarket Notification 5 10(k) K032288. Device Description: The Integra MOZAIK Osteoconductive Scaffold - Putty is a resorbable bone void filler made from…	Orthovita, Inc.	2003	—

Also cleared against K032288: 16 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
K231030	Cove Putty, OsteoCove Putty	SeaSpine Orthopedics Corporation	2023	0
K091302	Integra Mozaik and OS Moldable Morsels	Integra LifeSciences Corporation	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 11, 2011	Class II	Z-1796-2012	Employee error	The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly…
Oct 7, 2011	Not classified	Z-0986-2012	Error in labeling	Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
Jan 16, 2009	Not classified	Z-1034-2009	Pending	Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K231030 (SeaSpine Orthopedics Corporation, 2023) has gone furthest, with 0 descendants of its own.
16 other devices also cite its predicate K032288.

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?

Integra MOZAIKTM Osteoconductive Scaffold - Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK Putty is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIK Putty is resorbed and replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062353 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062353: Mozaik Bone Regeneration 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/K062353

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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