510(k) Report

510(k) · Cleared

Cleared

Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T

K040980510(k) TraditionalCleared Jul 14, 200490-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

Wrightmedicaltechnologyinc · MQV Filler, Bone Void, Calcium Compound

Cleared on Jul 14, 2004 after a 90-day review. The FDA summary names no predicate by number. 30 later devices descend from it.

Decided
Jul 14, 2004
Review
90 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
0

30 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2005: 4 descendants cleared2025: 2 descendants cleared2009: 2 descendants cleared2008: 7 descendants cleared2012: 2 descendants cleared2011: 3 descendants cleared2006: 1 descendant cleared2021: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2016: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
  2. Descendant · cites it directly · 28 of its ownK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
  3. Descendant · 2 generations on · 8 of its ownK050642 Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005
  4. Descendant · cites it directly · 6 of its ownK050690 ConnexusIsotis Orthobiologics, Inc. · 2005
  5. Descendant · cites it directly · 5 of its ownK061880 Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV · 2007
  6. Descendant · 2 generations on · 4 of its ownK113728 Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp. · 2012

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2005: 42006: 12007: 22008: 72009: 22011: 32012: 22014: 12016: 22018: 12021: 12022: 12023: 12025: 2
2005high 7 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 30 · See all
  • K040419Dynagraft IIIsotis Orthobiologics, Inc. · 2005 · cites it directly28descendants
  • K050642Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005 · 2 generations on8descendants
  • K050690ConnexusIsotis Orthobiologics, Inc. · 2005 · cites it directly6descendants
  • K061880Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV · 2007 · cites it directly5descendants
  • K113728Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp. · 2012 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040980Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite…Wrightmedicaltechnologyinc2004—
+1K040419Dynagraft IIIsotis Orthobiologics, Inc.2005—
+2K050642Orthoblast II Putty and PasteIsotis Orthobiologics, Inc.2005—
+1K050690ConnexusIsotis Orthobiologics, Inc.2005—
+1K061880Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV2007—
+2K113728Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200540
200610
200720
200870
200920
201130
201220
201410
201620
201810
202110
202210
202310
202520
FIG. 1 — Lineage of K040980, 2004–2025Source: 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?

The FDA summary names no predicate by number.

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K040419Dynagraft IIIsotis Orthobiologics, Inc.200528
K050690ConnexusIsotis Orthobiologics, Inc.20056
K061880Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV20075
K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)Wright Medical Technology, Inc. (Stryker Corporation)20250

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, K040419 (Isotis Orthobiologics, Inc., 2005) has gone furthest, with 28 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?

ALLOMATRIX® C Putty, ALLOMATRIX® Custom Putty and ALLOMATRIX® DR Putty are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

ALLOMATRIX® C Putty, ALLOMATRIX® Custom Putty and ALLOMATRIX® DR Putty are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Indications for use as stated in the FDA summary.

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311 FDA decisions under this applicant name. See the company

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Recent decisions in MQV

The MQV category page

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  • 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
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https://510kreport.com/device/K040980 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040980: Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040980

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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