510(k) Report

510(k) · Cleared

Cleared

Merries K-Phate Bone Graft Substitute

K063157510(k) TraditionalCleared Mar 10, 2008510-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

Merries International, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Mar 10, 2008 as substantially equivalent to K032268 (Biomatlante, 2003) and 5 other predicates after a 510-day review. Its family tree reaches back 5 generations to 1999.

Decided
Mar 10, 2008
Review
510 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K990131 (1999). 12 ancestors in all, the oldest K963587 (1997). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1997: 2 other ancestorsK990131 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute · Interpore Cross Intl. · 1999K020986 · Mastergraft Resorbable Ceramic · Medtronic Sofamor Danek, Inc. · 2002K032268 · MBCP · Biomatlante · 2003K043005 · Modification to MBCP · Biomatlante · 2005K051774 · MBCP · Biomatlante · 20061995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors K051774 · MBCP · Biomatlante · 2006K043005 · Modification to MBCP · Biomatlante · 2005K032268 · MBCP · Biomatlante · 2003K020986 · Mastergraft Resorbable Ceramic · Medtronic Sofamor Danek, Inc. · 2002K990131 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute · Interpore Cross Intl. · 1999−50
  1. Root · 5 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
  2. 4 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
  3. 3 generations backK032268 MBCPBiomatlante · 2003
  4. 2 generations backK043005 Modification to MBCPBiomatlante · 2005
  5. 1 generation backK051774 MBCPBiomatlante · 2006
  6. This deviceK063157 Merries K-Phate Bone Graft SubstituteMerries International, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K990131Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl.1999—
−4K020986Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc.2002—
−3K032268MBCPBiomatlante2003—
−2K043005Modification to MBCPBiomatlante2005—
−1K051774MBCPBiomatlante2006—
0 (this device)K063157Merries K-Phate Bone Graft SubstituteMerries International, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720
199910
200010
200210
200310
200410
FIG. 1 — Lineage of K063157, 1999–2008Source: 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? (6)

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
*K032268MBCP
Summary page 2
…alence: Merries K-PHATE Bone graft substitute is substantially equivalent in base materials, function and intended use to the following devices: * MBCPTM (K032268, K043005, and K051774) Manufactured by Biomatlante * Pro Osteon® 500R Resorbable Bone Graft Substitute (K990131)…
Biomatlante2003—
*K043005Modification to MBCP
Summary page 2
…Merries K-PHATE Bone graft substitute is substantially equivalent in base materials, function and intended use to the following devices: * MBCPTM (K032268, K043005, and K051774) Manufactured by Biomatlante * Pro Osteon® 500R Resorbable Bone Graft Substitute (K990131)…
Biomatlante2005—
*K051774MBCP
Summary page 2
…-PHATE Bone graft substitute is substantially equivalent in base materials, function and intended use to the following devices: * MBCPTM (K032268, K043005, and K051774) Manufactured by Biomatlante * Pro Osteon® 500R Resorbable Bone Graft Substitute (K990131) Manufactured…
Biomatlante2006—
*K990131Pro Osteon Implant 500R Resorbable Bone Graft Substitute
Summary page 2
…to the following devices: * MBCPTM (K032268, K043005, and K051774) Manufactured by Biomatlante * Pro Osteon® 500R Resorbable Bone Graft Substitute (K990131) Manufactured by Interpore Cross INTL. * Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409)…
Interpore Cross Intl.1999—
*K032409Vitoss Scaffold Synthetic Cancellous Bone Void Filler
Summary page 2
…o Osteon® 500R Resorbable Bone Graft Substitute (K990131) Manufactured by Interpore Cross INTL. * Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409) Manufactured by Orthovita, Inc. * BoneSave Bone void Filler(K033258) Manufactured by Howmedica Osteonic…
Orthovita, Inc.2003—
*K033258Bonesave Bone Void Filler
Summary page 2
…terpore Cross INTL. * Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409) Manufactured by Orthovita, Inc. * BoneSave Bone void Filler(K033258) Manufactured by Howmedica Osteonics Corp. 10. Testing summary: * Chemical requirements conform to the ASTM Fl18…
Howmedica Osteonics2004—

Also cleared against K032268: 10 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?

  • The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
  • None of the 12 ancestors has a recall.
  • 10 other devices also cite its predicate K032268.

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. 2008, 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?

Merries K-PHATE is intended to be packed into bony defects of the skeletal system ( extremities, spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

Indications for use as stated in the FDA summary.

Also cleared against K032268

10 other devices cite the same predicate.

  • K172237Bicera Resorbable Bone SubstituteWiltrom Corporation Limited · 2018
  • K161859MagnetOsXpand Biotechnology BV · 2017
  • K110949Bicera (TM) Resorbable Bone SubstituteWiltrom Corporation Limited · 2012
  • K090387Kainos+Signus Medizintechnik GmbH · 2009
  • K071876Cross.BoneTriMed, Inc. · 2007
  • K051774MBCPBiomatlante · 2006

More from Merries International, Inc.

2 FDA decisions under this applicant name. See the company

  • K051698Merries Uni-Osteo, Model CS30250-CS10102Merries International, Inc. · 2005

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/K063157 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063157: Merries K-Phate Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063157

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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