510(k) Report

510(k) · Cleared

Cleared

Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)

K252085510(k) TraditionalCleared Sep 30, 202590-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

Wright Medical Technology, Inc. (Stryker Corporation) · MQV Filler, Bone Void, Calcium Compound

Cleared on Sep 30, 2025 as substantially equivalent to K041168 (Wrightmedicaltechnologyinc, 2004) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 2004.

Decided
Sep 30, 2025
Review
90 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K040980 (2004). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2004: 1 other ancestorK040980 · Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T · Wrightmedicaltechnologyinc · 2004200020052010201520202025
Other ancestors, by generation 1 generation back: 2 other ancestors K040980 · Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T · Wrightmedicaltechnologyinc · 20040
  1. Root · 1 generation backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
  2. This deviceK252085 Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix…Wright Medical Technology, Inc. (Stryker Corporation) · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K040980Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite…Wrightmedicaltechnologyinc2004—
0 (this device)K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR…Wright Medical Technology, Inc. (Stryker Corporation)2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
FIG. 1 — Lineage of K252085, 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? (3)

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
*K041168Allomatrix Putty
Summary page 5
…21 CFR 888.3045 – Class II Device Product Code, Device Panel: MQV, MBP (a)(3). Primary Predicate Device(s): Allomatrix® Putty (K041168), Allomatrix® C (K040980), Allomatrix® DR (K040980),…
Wrightmedicaltechnologyinc2004—
*K040980Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold…
Summary page 5
…MQV, MBP (a)(3). Primary Predicate Device(s): Allomatrix® Putty (K041168), Allomatrix® C (K040980), Allomatrix® DR (K040980), Allomatrix® Custom (K061939) (a)(4). Device Des…
Wrightmedicaltechnologyinc2004—
*K061939Modification to Allomatrix Custom
Summary page 5
…rix® C (K040980), Allomatrix® DR (K040980), Allomatrix® Custom (K061939) (a)(4). Device Description The Allomatrix® family of bone void fillers are comprised of demineralized bone matrix…
Wrightmedicaltechnologyinc2006—

Also cleared against K041168: 8 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?

  • None of the 3 ancestors has a recall.
  • 8 other devices also cite its predicate K041168.

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. 2025, 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?

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

Read the full statement (142 words)

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

AlloMatrix® Custom Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of bony structure. AlloMatrix® Custom Putty is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine), and as a bone void filler in 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K041168

8 other devices cite the same predicate.

  • K091912B-Genin and R-GeninBerkeley Advanced Biomaterials, Inc. · 2010
  • K071849Allofuse Gel and PuttyAllosource, Inc. · 20081 recall
  • K072265Progenix DMB PuttyMedtronic Sofamor Danek · 2008
  • K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
  • K043209Viagraf DBM PasteOsteotech, Inc. · 2005
  • K053098Optium DBM Gel and PuttyLifenet · 2005

More from Wright Medical Technology, Inc.…

2 FDA decisions under this applicant name. See the company

  • K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation) · 2025

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/K252085 · printed Nov 4, 2026

Cite this page

510(k) Report. “K252085: Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252085

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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