510(k) · Cleared

Cleared

Novabone-Bioactive Synthetic Graft

K052494510(k) TraditionalCleared Nov 3, 200552-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

Novabone Products, LLC · MQV Filler, Bone Void, Calcium Compound

Cleared on Nov 3, 2005 as substantially equivalent to K021336 (Novabone Products, LLC, 2002) after a 52-day review. Its family tree reaches back 3 generations to 1996. 123 later devices descend from it.

Decided: Nov 3, 2005
Review: 52 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K960978 (1996). 4 ancestors in all. 123 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
1 generation backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
This deviceK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
Descendant · cites it directly · 71 of its ownK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
Descendant · 2 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
Descendant · cites it directly · 51 of its ownK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
Descendant · 2 generations on · 50 of its ownK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
Descendant · 2 generations on · 47 of its ownK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010

Showing 5 of 123 descendants. See all descendants

Descendants cleared per year

2006high 13 (2025) · low 1 (2006)2026

Most influential descendants

Showing 5 of 123 · See all

K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008 · cites it directly71descendants
K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 2 generations on59descendants
K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007 · cites it directly51descendants
K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008 · 2 generations on50descendants
K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010 · 2 generations on47descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K960978	Wright Plaster of Paris Pellets (Subject to Revision)	Wrightmedicaltechnologyinc	1996	—
−2	K980817	Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…	Interpore Intl.	1998	—
−1	K021336	Novabone-Resorbable Bone Graft Substitute	Novabone Products, LLC	2002	—
0 (this device)	K052494	Novabone-Bioactive Synthetic Graft	Novabone Products, LLC	2005	—
+1	K080009	Novabone Putty- Bioactive Synthetic Graft	Novabone Products, LLC	2008	—
+2	K082672	Novabone Putty-Bioactive Synthetic Bone Graft	Novabone Products, LLC	2008	—
+1	K072184	Vitoss Bioactive Foam Bone Graft Substitute	Orthovita, Inc.	2007	—
+2	K081439	Vitoss Bioactive Foam Pack Bone Graft Substitute	Orthovita, Inc.	2008	—
+2	K101860	Novabone Putty- Bioactive Synthetic Bone Graft	Novabone Products, LLC	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	6	0
2008	5	0
2009	6	0
2010	7	0
2011	9	0
2012	2	0
2013	3	0
2014	8	0
2015	7	0
2016	3	0
2017	5	0
2018	5	0
2019	4	0
2020	2	0
2021	2	0
2022	5	0
2023	10	0
2024	12	0
2025	13	0
2026	8	0

FIG. 1 — Lineage of K052494, 1996–2026Source: 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
*	K021336	Novabone-Resorbable Bone Graft Substitute Summary page 1 …Classification Name: Unknown 3. Legally Marketed Predicate Device: Predicate #1: NovaBone - Resorbable Bone Graft Substitute [K021336] 4. Device Description NovaBone is a one-component resorbable bone void filler composed of a synthetic calcium phosp…	Novabone Products, LLC	2002	—

Also cleared against K021336: 12 other devices →

What descends from it? (123)

See all 123

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

Number	Device	Applicant	Decided	Descendants
K080009	Novabone Putty- Bioactive Synthetic Graft	Novabone Products, LLC	2008	71
K072184	Vitoss Bioactive Foam Bone Graft Substitute	Orthovita, Inc.	2007	51
K132805	BG Morsels	Prosidyan, Inc.	2014	33
K053387	Perioglas Bone Graft Particulate	Novabone Products, LLC	2006	13
K070998	Inion Biorestore	Inion OY	2007	4

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 9 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K080009 (Novabone Products, LLC, 2008) has gone furthest, with 71 descendants of its own.
12 other devices also cite its predicate K021336.

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?

NovaBone Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052494 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052494: Novabone-Bioactive Synthetic Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052494

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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