510(k) · Cleared

Recalled · Class II · 2025

Biosorb Resorbable Void Filler

K021963510(k) TraditionalCleared Jan 28, 2003228-day reviewClass II21 CFR 888.3045Recalls 1

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

Sciences ET Bio Materiaux (Sbm) · MQV Filler, Bone Void, Calcium Compound

Cleared on Jan 28, 2003 as substantially equivalent to K994337 (Orthovita Co., 2000) after a 228-day review. Its family tree reaches back 1 generation to 2000. 21 later devices descend from it. It has been recalled once.

Decided: Jan 28, 2003
Review: 228 days
Class: Class II
Product code: MQV
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K994337 (2000). 21 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
This deviceK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003
Descendant · cites it directly · 7 of its ownK050407 Ligafix Resorbable Interference Screw, Models 30 and 60Sciences For Bio Materials · 2005
Descendant · 2 generations on · 6 of its ownK061262 Ligafix Interference ScrewSciences For Bio Materials · 2006
Descendant · cites it directly · 4 of its ownK041421 Name Bone Void FillerStryker Biotech · 2004 · Recalled
Descendant · 2 generations on · 3 of its ownK070507 Modification to: Ligafix Interference ScrewScience For Biomaterials · 2007 · Recalled
Descendant · 2 generations on · 3 of its ownK051722 Tricos TBaxter Healthcare Corp · 2005

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2003high 4 (2004) · low 0 (2010)2026

Most influential descendants

Showing 5 of 21 · See all

K050407Ligafix Resorbable Interference Screw, Models 30 and 60Sciences For Bio Materials · 2005 · cites it directly7descendants
K061262Ligafix Interference ScrewSciences For Bio Materials · 2006 · 2 generations on6descendants
K041421Name Bone Void FillerStryker Biotech · 2004 · cites it directly4descendants
K070507Modification to: Ligafix Interference ScrewScience For Biomaterials · 2007 · 2 generations on3descendants
K051722Tricos TBaxter Healthcare Corp · 2005 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K994337	Vitoss Scaffold Synthetic Cancellous Bone Void Filler	Orthovita Co.	2000	—
0 (this device)	K021963	Biosorb Resorbable Void Filler	Sciences ET Bio Materiaux (Sbm)	2003	—
+1	K050407	Ligafix Resorbable Interference Screw, Models 30 and 60	Sciences For Bio Materials	2005	—
+2	K061262	Ligafix Interference Screw	Sciences For Bio Materials	2006	—
+1	K041421	Name Bone Void Filler	Stryker Biotech	2004	1
+2	K070507	Modification to: Ligafix Interference Screw	Science For Biomaterials	2007	1
+2	K051722	Tricos T	Baxter Healthcare Corp	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	4	0
2005	2	0
2006	3	0
2007	2	0
2008	3	0
2009	1	0
2012	1	0
2013	1	0
2015	1	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K021963, 2000–2023Source: 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

Get a 510(k) Report

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K994337	Vitoss Scaffold Synthetic Cancellous Bone Void Filler Summary page 1 …October 20,2002 2. PREDICATE DEVICES Trade Name VITOSS scaffold synthetic cancellous bone void filler K 994337 @ PRO OSTEON 500R Resorbable Bone void filler…	Orthovita Co.	2000	—
Kept off the family tree	K098017	PRO OSTEON 500R Resorbable Bone void filler Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

Also cleared against K994337: 25 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K050407	Ligafix Resorbable Interference Screw, Models 30 and 60	Sciences For Bio Materials	2005	7
K041421	Name Bone Void Filler	Stryker Biotech	2004	4
K031826	TRIHA +	Teknimed, S.A.	2003	2
K140913	Nuros Bone Graft Substitute	Oriental Resources Development Limited	2015	0
K130953	Neotis; Neotis 50	Sbm Sciences For Bio Materials	2013	0
K061462	BF+ (PH)	Ldr Spine USA	2006	0
K061022	Bio 1-Kit Biosorb Filled Cartridge	Science For Biomaterials	2006	0
K040454	Biofill Bone Void Filler	Scient'X	2004	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 7, 2025	Class II	Z-1718-2025	Process control	Vials of implant bone granules may contain less product then specified on labeling.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K050407 (Sciences For Bio Materials, 2005) has gone furthest, with 7 descendants of its own.
25 other devices also cite its predicate K994337.

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?

BIOSORB® Resorbable Void Filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

BIOSORB® Resorbable Void Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021963 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021963: Biosorb Resorbable 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/K021963

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