510(k) Report

510(k) · Cleared

Cleared

Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6 Strips Per Box)

K000122510(k) TraditionalCleared Sep 20, 2001611-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

Neucoll, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Sep 20, 2001 after a 611-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 253 later devices descend from it.

Decided
Sep 20, 2001
Review
611 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
0

253 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2009: 13 descendants cleared2005: 7 descendants cleared2006: 8 descendants cleared2008: 20 descendants cleared2001: 1 descendant cleared2004: 3 descendants cleared2007: 8 descendants cleared2015: 10 descendants cleared2014: 15 descendants cleared2017: 10 descendants cleared2010: 11 descendants cleared2011: 10 descendants cleared2022: 13 descendants cleared2013: 5 descendants cleared2023: 20 descendants cleared2019: 7 descendants cleared2020: 8 descendants cleared2024: 23 descendants cleared2016: 4 descendants cleared2026: 12 descendants cleared2018: 13 descendants cleared2021: 10 descendants cleared2025: 19 descendants cleared2012: 3 descendants cleared200020052010201520202025
  1. This deviceK000122 Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model…Neucoll, Inc. · 2001
  2. Descendant · cites it directly · 186 of its ownK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
  3. Descendant · 2 generations on · 120 of its ownK060728 Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006
  4. Descendant · cites it directly · 84 of its ownK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
  5. Descendant · 3 generations on · 71 of its ownK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
  6. Descendant · 2 generations on · 67 of its ownK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005

Showing 5 of 253 descendants. See all descendants

Descendants cleared per year

2001: 12004: 32005: 72006: 82007: 82008: 202009: 132010: 112011: 102012: 32013: 52014: 152015: 102016: 42017: 102018: 132019: 72020: 82021: 102022: 132023: 202024: 232025: 192026: 12
2001high 23 (2024) · low 0 (2002)2026

Most influential descendants

Showing 5 of 253 · See all
  • K020078Exactech Resorbable Bone PasteExactech, Inc. · 2004 · cites it directly186descendants
  • K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006 · 2 generations on120descendants
  • K012751Healos Bone Graft MaterialOrquest, Inc. · 2001 · cites it directly84descendants
  • K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008 · 3 generations on71descendants
  • K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005 · 2 generations on67descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000122Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X…Neucoll, Inc.2001—
+1K020078Exactech Resorbable Bone PasteExactech, Inc.2004—
+2K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006—
+1K012751Healos Bone Graft MaterialOrquest, Inc.2001—
+3K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC2008—
+2K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200430
200570
200680
200780
2008200
2009130
2010110
2011100
201230
201350
2014150
2015100
201640
2017100
2018130
201970
202080
2021100
2022130
2023200
2024230
2025190
2026120
FIG. 1 — Lineage of K000122, 2001–2026Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (253)

See all 253

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

NumberDeviceApplicantDecidedDescendants
K020078Exactech Resorbable Bone PasteExactech, Inc.2004186
K012751Healos Bone Graft MaterialOrquest, Inc.200184
K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640
K082166Mastergraft StripMedtronic Sofamor Danek200938
K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511
K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083
K051722Tricos TBaxter Healthcare Corp20053

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, K020078 (Exactech, Inc., 2004) has gone furthest, with 186 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—

More from Neucoll, Inc.

15 FDA decisions under this applicant name. See the company

  • P900039/S015Collagraft Strip Bone Graft MatrixNeucoll, Inc. · 2005
  • P900039/S013NeugraftNeucoll, Inc. · 2004
  • P900039/S012Collagraft Strip Bone Graft MatrixNeucoll, Inc. · 2002
  • P900039/S011Collagraft Strip Bone Graft MatrixNeucoll, Inc. · 2002
  • P900039/S010Collagraft Strip Bone Graft MatrixNeucoll, Inc. · 1998

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/K000122 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000122: Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6 Strips Per Box).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000122

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026