510(k) Report

510(k) · Cleared

Cleared

Neotis; Neotis 50

K130953510(k) SpecialCleared Jul 15, 2013101-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

Sbm Sciences For Bio Materials · MQV Filler, Bone Void, Calcium Compound

Cleared on Jul 15, 2013 as substantially equivalent to K021963 (Sciences ET Bio Materiaux (Sbm), 2003) and 1 other predicate after a 101-day review. Its family tree reaches back 2 generations to 2000.

Decided
Jul 15, 2013
Review
101 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K994337 (2000). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestorK994337 · Vitoss Scaffold Synthetic Cancellous Bone Void Filler · Orthovita Co. · 2000K021963 · Biosorb Resorbable Void Filler · Sciences ET Bio Materiaux (Sbm) · 2003 · recalled2000200520102015
Other ancestors, by generation 1 generation 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 deviceK130953 Neotis; Neotis 50Sbm Sciences For Bio Materials · 2013
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)K130953Neotis; Neotis 50Sbm Sciences For Bio Materials2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K130953, 2000–2013Source: 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
*K021963Biosorb Resorbable Void Filler
Summary page 1
…QV CFR section 888.3045 Device panel Orthopedic Legally marketed predicate BIOSORB RESORBABLE BONE VOID FILLER (K(021963 and K(071155) devices Reason for speciat 510k Extension of the range of products SC…
Sciences ET Bio Materiaux (Sbm)20031
*K071155Modification to: Biosorb Resorbable Void Filler
Summary page 3
…LER products have the same fundamental scientific technology, operating principle and intended use as previously cleared BIOSORB RESORBABLE BONE VOID FILLER K(021963 and K071155. The design modification reduces the risk of inadequate filling of the HTO opening with concern to former wedges, and does not ge…
Science For Biomaterials2007—

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 13 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
  • 1 of the 3 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. 2013, this device’s year, is highlighted.

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 Bone 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, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable BoneVoid Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue lngrowth. Rigid…

Read the full statement (117 words)

BIOSORB Resorbable Bone 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, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable BoneVoid Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue lngrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect In all plans.

In addition, when used with appropriate opening osteotomy system devices, plates and screws, BIOSORB Resorbable Bone Void Filler Is Intended to be used as a bone void filler In tibial osteotomies.

Indications for use as stated in the FDA summary.

Also cleared against K021963

7 other devices cite the same predicate.

  • K140913Nuros Bone Graft SubstituteOriental Resources Development Limited · 2015
  • K061462BF+ (PH)Ldr Spine USA · 2006
  • K061022Bio 1-Kit Biosorb Filled CartridgeScience For Biomaterials · 2006
  • K050407Ligafix Resorbable Interference Screw, Models 30 and 60Sciences For Bio Materials · 2005
  • K041421Name Bone Void FillerStryker Biotech · 20041 recall
  • K040454Biofill Bone Void FillerScient'X · 2004

More from Sbm Sciences For Bio Materials

3 FDA decisions under this applicant name. See the company

  • K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials · 2015
  • K122228Ligafix Interference ScrewSbm Sciences For Bio Materials · 2012

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/K130953 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130953: Neotis; Neotis 50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130953

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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