510(k) Report

510(k) · Cleared

Cleared

Bio 1-Kit Biosorb Filled Cartridge

K061022510(k) TraditionalCleared May 24, 200641-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

Science For Biomaterials · MQV Filler, Bone Void, Calcium Compound

Cleared on May 24, 2006 as substantially equivalent to K032130 (Orthovita, Inc., 2003) and 1 other predicate after a 41-day review. Its family tree reaches back 2 generations to 2000.

Decided
May 24, 2006
Review
41 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K994337 (2000). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 2 other ancestorsK994337 · Vitoss Scaffold Synthetic Cancellous Bone Void Filler · Orthovita Co. · 2000K021963 · Biosorb Resorbable Void Filler · Sciences ET Bio Materiaux (Sbm) · 2003 · recalled20002002200420062008
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K021963 · Biosorb Resorbable Void Filler · Sciences ET Bio Materiaux (Sbm) · 2003 · recalledK994337 · Vitoss Scaffold Synthetic Cancellous Bone Void Filler · Orthovita Co. · 20000
  1. Root · 2 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
  2. 1 generation backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
  3. This deviceK061022 Bio 1-Kit Biosorb Filled CartridgeScience For Biomaterials · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K994337Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co.2000—
−1K021963Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm)20031
0 (this device)K061022Bio 1-Kit Biosorb Filled CartridgeScience For Biomaterials2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200320
FIG. 1 — Lineage of K061022, 2000–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K032130Vitoss-Filled Cartridge
Summary page 1
…panel Orthopedic Legally marketed BIOSORB ® Resorbable Void Filler K021963 (SBM) predicate devices VITOSS-Fitled cartridge K032130 (Orthovita Inc) Submitter SCIENCE FOR BIOMATERIALS Sciences et Bio Mat6riau…
Orthovita, Inc.2003—
*K021963Biosorb Resorbable Void Filler
Summary page 1
…MQV CFR section 21CFR 888.3045 Device panel Orthopedic Legally marketed BIOSORB ® Resorbable Void Filler K021963 (SBM) predicate devices VITOSS-Fitled cartridge K032130 (Orthovita Inc) Submitter SCIENCE FOR…
Sciences ET Bio Materiaux (Sbm)20031

Also cleared against K032130: 2 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 6 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K032130.

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

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
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

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

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…

Read the full statement (142 words)

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.

The BIO 1-KIT ®BIOSORB filled cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with the BIOSORB * Resorbable Void Filler and deliver the material to the orthopedic surgical site.

Indications for use as stated in the FDA summary.

Also cleared against K032130

2 other devices cite the same predicate.

  • K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft…Orthovita, Inc. · 2008
  • K043172Trugraft BGS Syringe, Model 600-041Osteobiologics, Inc. · 2005

More from Science For Biomaterials

6 FDA decisions under this applicant name. See the company

  • K140226Otis-C-Plus, Neotis Plate, Screw 06.5Science For Biomaterials · 2014
  • K120818Otis-C PlusScience For Biomaterials · 2012
  • K090994Ligafix Interface ScrewScience For Biomaterials · 2009
  • K071155Modification to: Biosorb Resorbable Void FillerScience For Biomaterials · 2007
  • K070507Modification to: Ligafix Interference ScrewScience For Biomaterials · 20071 recall

Recent decisions in MQV

The MQV category page

  • K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 2026
  • K260364Device 300419 StripGeistlich Pharma AG · 2026
  • K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd. · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K253524Adaptos®Fuse Bone GraftBiomendex OY · 2026

https://510kreport.com/device/K061022 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061022: Bio 1-Kit Biosorb Filled Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061022

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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