510(k) Report

510(k) · Cleared

Cleared

Millenium's Skelite Synthetic Resorbable Bone Void Filler

K011726510(k) TraditionalCleared May 16, 2002346-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

Millenium Biologix, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on May 16, 2002 after a 346-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 114 later devices descend from it.

Decided
May 16, 2002
Review
346 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
0

114 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 1 descendant cleared2015: 3 descendants cleared2009: 2 descendants cleared2008: 7 descendants cleared2017: 4 descendants cleared2014: 4 descendants cleared2020: 6 descendants cleared2016: 1 descendant cleared2019: 4 descendants cleared2018: 3 descendants cleared2011: 1 descendant cleared2022: 5 descendants cleared2021: 3 descendants cleared2025: 20 descendants cleared2023: 13 descendants cleared2024: 25 descendants cleared2026: 11 descendants cleared200020052010201520202025
  1. This deviceK011726 Millenium's Skelite Synthetic Resorbable Bone Void FillerMillenium Biologix, Inc. · 2002
  2. Descendant · cites it directly · 113 of its ownK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
  3. Descendant · 2 generations on · 111 of its ownK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
  4. Descendant · 3 generations on · 79 of its ownK080736 Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008
  5. Descendant · 4 generations on · 76 of its ownK151584 AttraX PuttyProgentix Orthobiology BV · 2015
  6. Descendant · 4 generations on · 71 of its ownK191974 NuVasive AttraX PuttyNu Vasive, Incorporated · 2019

Showing 5 of 114 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12008: 72009: 22011: 12014: 42015: 32016: 12017: 42018: 32019: 42020: 62021: 32022: 52023: 132024: 252025: 202026: 11
2004high 25 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 114 · See all
  • K040082Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004 · cites it directly113descendants
  • K071206Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · 2 generations on111descendants
  • K080736Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008 · 3 generations on79descendants
  • K151584AttraX PuttyProgentix Orthobiology BV · 2015 · 4 generations on76descendants
  • K191974NuVasive AttraX PuttyNu Vasive, Incorporated · 2019 · 4 generations on71descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011726Millenium's Skelite Synthetic Resorbable Bone Void FillerMillenium Biologix, Inc.2002—
+1K040082Pore-SI Bone Graft SubstituteApatech, Ltd.2004—
+2K071206Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd.20071
+3K080736Actifuse Shape Bone Graft SubstituteApatech, Ltd.2008—
+4K151584AttraX PuttyProgentix Orthobiology BV2015—
+4K191974NuVasive AttraX PuttyNu Vasive, Incorporated2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
200870
200920
201110
201440
201530
201610
201740
201830
201940
202060
202130
202250
2023130
2024250
2025200
2026110
FIG. 1 — Lineage of K011726, 2002–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (114)

See all 114

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040082Pore-SI Bone Graft SubstituteApatech, Ltd.2004113

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?

  • Of its descendants, K040082 (Apatech, Ltd., 2004) has gone furthest, with 113 descendants of its own.

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?

The Skelite™ Synthetic Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intringic to the stability of the bony structure. Skelite M 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. The product can be mixed with bone marrow.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Millenium Biologix, Inc.

2 FDA decisions under this applicant name. See the company

  • K051836Skelite Resorbable Cement RestrictorMillenium Biologix, Inc. · 2005

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/K011726 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011726: Millenium's Skelite Synthetic Resorbable 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/K011726

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026