510(k) Report

510(k) · Cleared

Cleared

Allomatrix Putty

K041168510(k) TraditionalCleared Aug 2, 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 Aug 2, 2004 after a 90-day review. The FDA summary names no predicate by number. 55 later devices descend from it.

Decided
Aug 2, 2004
Review
90 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
0

55 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2008: 7 descendants cleared2010: 5 descendants cleared2025: 2 descendants cleared2005: 4 descendants cleared2006: 1 descendant cleared2019: 2 descendants cleared2009: 4 descendants cleared2007: 1 descendant cleared2024: 3 descendants cleared2015: 4 descendants cleared2011: 4 descendants cleared2012: 2 descendants cleared2017: 2 descendants cleared2013: 3 descendants cleared2022: 2 descendants cleared2018: 2 descendants cleared2014: 2 descendants cleared2016: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK041168 Allomatrix PuttyWrightmedicaltechnologyinc · 2004
  2. Descendant · cites it directly · 39 of its ownK053098 Optium DBM Gel and PuttyLifenet · 2005
  3. Descendant · 2 generations on · 34 of its ownK063050 Cap PlusEtex Corp. · 2007
  4. Descendant · 2 generations on · 29 of its ownK080329 Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008
  5. Descendant · 3 generations on · 28 of its ownK090310 EquivaboneEtex Corp. · 2009
  6. Descendant · 3 generations on · 25 of its ownK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2005: 42006: 12007: 12008: 72009: 42010: 52011: 42012: 22013: 32014: 22015: 42016: 12017: 22018: 22019: 22020: 12021: 12022: 22023: 22024: 32025: 2
2005high 7 (2008) · low 0 (2026)2026

Most influential descendants

Showing 5 of 55 · See all
  • K053098Optium DBM Gel and PuttyLifenet · 2005 · cites it directly39descendants
  • K063050Cap PlusEtex Corp. · 2007 · 2 generations on34descendants
  • K080329Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008 · 2 generations on29descendants
  • K090310EquivaboneEtex Corp. · 2009 · 3 generations on28descendants
  • K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009 · 3 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041168Allomatrix PuttyWrightmedicaltechnologyinc2004—
+1K053098Optium DBM Gel and PuttyLifenet2005—
+2K063050Cap PlusEtex Corp.2007—
+2K080329Cap Plus, Equivabone, Cap/DBMEtex Corp.2008—
+3K090310EquivaboneEtex Corp.2009—
+3K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200540
200610
200710
200870
200940
201050
201140
201220
201330
201420
201540
201610
201720
201820
201920
202010
202110
202220
202320
202430
202520
FIG. 1 — Lineage of K041168, 2004–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (55)

See all 55

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

NumberDeviceApplicantDecidedDescendants
K053098Optium DBM Gel and PuttyLifenet200539
K043048Grafton Plus DBM PasteOsteotech, Inc.200510
K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek20069
K072265Progenix DMB PuttyMedtronic Sofamor Danek20084
K091912B-Genin and R-GeninBerkeley Advanced Biomaterials, Inc.20101
K071849Allofuse Gel and PuttyAllosource, Inc.20081
K052913Ignite Bone Void Filler KitWrightmedicaltechnologyinc20051
K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)Wright Medical Technology, Inc. (Stryker Corporation)20250
K043209Viagraf DBM PasteOsteotech, Inc.20050

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, K053098 (Lifenet, 2005) has gone furthest, with 39 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® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Putty is 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.

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

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/K041168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041168: Allomatrix Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041168

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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