510(k) Report

510(k) · Cleared

Cleared

WMT-TCP Bone Graft Substitute

K022629510(k) AbbreviatedCleared Nov 5, 200290-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 Nov 5, 2002 as substantially equivalent to K013966 (Cerabio, LLC, 2002) after a 90-day review. Its family tree reaches back 1 generation to 2002. 58 later devices descend from it.

Decided
Nov 5, 2002
Review
90 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K013966 (2002). 58 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared2006: 3 descendants cleared2005: 1 descendant cleared2007: 1 descendant cleared2013: 1 descendant cleared2026: 2 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared2012: 2 descendants cleared2011: 2 descendants cleared2015: 3 descendants cleared2014: 5 descendants cleared2016: 3 descendants cleared2019: 2 descendants cleared2024: 5 descendants cleared2017: 2 descendants cleared2023: 6 descendants cleared2020: 7 descendants cleared2018: 3 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2025: 2 descendants clearedK013966 · Apatight-TCP Bone Graft Substitute · Cerabio, LLC · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 7 descendants6 generations forward: 5 descendants7 generations forward: 9 descendants8 generations forward: 15 descendants9 generations forward: 5 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K013966 · Apatight-TCP Bone Graft Substitute · Cerabio, LLC · 20020+5+10
  1. Root · 1 generation backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
  2. This deviceK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
  3. Descendant · cites it directly · 52 of its ownK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
  4. Descendant · 2 generations on · 51 of its ownK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
  5. Descendant · 3 generations on · 45 of its ownK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  6. Descendant · 4 generations on · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
  7. Descendant · 5 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2003: 22005: 12006: 32007: 12008: 12010: 12011: 22012: 22013: 12014: 52015: 32016: 32017: 22018: 32019: 22020: 72021: 22022: 22023: 62024: 52025: 22026: 2
2003high 7 (2020) · low 0 (2004)2026

Most influential descendants

Showing 5 of 58 · See all
  • K031817Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003 · cites it directly52descendants
  • K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · 2 generations on51descendants
  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010 · 3 generations on45descendants
  • K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · 4 generations on41descendants
  • K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 5 generations on40descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013966Apatight-TCP Bone Graft SubstituteCerabio, LLC2002—
0 (this device)K022629WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc2002—
+1K031817Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc2003—
+2K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.20052
+3K100754Graft Delivery System Model SA-6115Micromedics, Inc.2010—
+4K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC2011—
+5K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200510
200630
200710
200810
201010
201120
201220
201310
201450
201530
201630
201720
201830
201920
202070
202120
202220
202360
202450
202520
202620
FIG. 1 — Lineage of K022629, 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 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? (1)

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
*K013966Apatight-TCP Bone Graft SubstituteCerabio, LLC2002—

Also cleared against K013966: 1 other device →

What descends from it? (58)

See all 58

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

NumberDeviceApplicantDecidedDescendants
K031817Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc200352
K051093Osteopore PCL ScaffoldOsteopore, Inc.20062
K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc.20031

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?

  • Its one ancestor has no recall.
  • Of its descendants, K031817 (Wrightmedicaltechnologyinc, 2003) has gone furthest, with 52 descendants of its own.
  • 1 other device also cites its predicate K013966.

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?

WMT- TCP Bone Graft is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The WMT-TCP is intended 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. WMT- TCP Bone Graft Substitute can be combined with autogenous bone marrow aspirate and/or biood. The product resorbs and is replaced with bone during the healing process.

The WMT- TCP Bone Graft Substitute is provided sterile for single use only and should not be resterilized.

Indications for use as stated in the FDA summary.

Also cleared against K013966

1 other device cites the same predicate.

  • K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003

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/K022629 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022629: WMT-TCP Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022629

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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