510(k) · Cleared

Cleared

Biofill Bone Void Filler

K040454510(k) TraditionalCleared May 7, 200474-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

Scient'X · MQV Filler, Bone Void, Calcium Compound

Cleared on May 7, 2004 as substantially equivalent to K021963 (Sciences ET Bio Materiaux (Sbm), 2003) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 2000.

Decided: May 7, 2004
Review: 74 days
Class: Class II
Product code: MQV
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K994337 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
1 generation backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
This deviceK040454 Biofill Bone Void FillerScient'X · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K994337	Vitoss Scaffold Synthetic Cancellous Bone Void Filler	Orthovita Co.	2000	—
−1	K021963	Biosorb Resorbable Void Filler	Sciences ET Bio Materiaux (Sbm)	2003	1
0 (this device)	K040454	Biofill Bone Void Filler	Scient'X	2004	—

FIG. 1 — Lineage of K040454, 2000–2004Source: 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
*	K021963	Biosorb Resorbable Void Filler Summary page 1 …me Bone void filler Classification name Filler, calcium sulfate, preformed pellets Equivalent Device Biofill is equivalent in material, indications and use as BIOSORB (K021963) (Scienccs et Bio Matcriaux, Lourdes, France) and VitossTM Scaffold (K994337) (Orthovita, Inc. (Malvern PA). Device Description…	Sciences ET Bio Materiaux (Sbm)	2003	1
*	K994337	Vitoss Scaffold Synthetic Cancellous Bone Void Filler Summary page 1 …ellets Equivalent Device Biofill is equivalent in material, indications and use as BIOSORB (K021963) (Scienccs et Bio Matcriaux, Lourdes, France) and VitossTM Scaffold (K994337) (Orthovita, Inc. (Malvern PA). Device Description Biofill Bone Void Filler is a tricalcium phosphate bone void filler. It is s…	Orthovita Co.	2000	—

Also cleared against K021963: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 4 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
1 of the 2 ancestors has a recall of any class.
7 other devices also cite its predicate K021963.

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?

Biofill is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Biofill is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Biofill should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Biofill is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040454 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040454: Biofill Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040454

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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