510(k) Report

510(k) · Cleared

Cleared

Comporus

K062691510(k) TraditionalCleared Apr 15, 2008582-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

Takiron Co., Ltd. · MQV Filler, Bone Void, Calcium Compound

Cleared on Apr 15, 2008 as substantially equivalent to K980817 (Interpore Intl., 1998) and 3 other predicates after a 582-day review. Its family tree reaches back 3 generations to 1996.

Decided
Apr 15, 2008
Review
582 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K960978 (1996). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 2 other ancestors2002: 1 other ancestor1997: 1 other ancestorK960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 1996K980817 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L · Interpore Intl. · 1998K030288 · Polygraft Bone Graft Substitute · Osteobiologics, Inc. · 20031995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K030288 · Polygraft Bone Graft Substitute · Osteobiologics, Inc. · 2003K980817 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L · Interpore Intl. · 1998K960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 19960
  1. Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. 1 generation backK030288 Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
  4. This deviceK062691 ComporusTakiron Co., Ltd. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−2K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
−1K030288Polygraft Bone Graft SubstituteOsteobiologics, Inc.2003—
0 (this device)K062691ComporusTakiron Co., Ltd.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200320
FIG. 1 — Lineage of K062691, 1996–2008Source: 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? (4)

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
*K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…
Summary page 1
…. has not yet obtained an Establishment Registration Number. Legally Marketed Predicate Devices: INTERPORE International; Pro Osteon ® 50OR Resorbable Bone Void Filler (K980817) Orthovita, Inc.; Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409) OsteoBiologics, Inc.; PolyGraftTM BGS; Bone Gr…
Interpore Intl.1998—
*K032409Vitoss Scaffold Synthetic Cancellous Bone Void Filler
Summary page 1
…dicate Devices: INTERPORE International; Pro Osteon ® 50OR Resorbable Bone Void Filler (K980817) Orthovita, Inc.; Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409) OsteoBiologics, Inc.; PolyGraftTM BGS; Bone Graft Substitute (K030288) Berkeley Advanced Biomaterials, INC.; Bi-OsteticTM (K0237…
Orthovita, Inc.2003—
*K030288Polygraft Bone Graft Substitute
Summary page 1
…one Void Filler (K980817) Orthovita, Inc.; Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409) OsteoBiologics, Inc.; PolyGraftTM BGS; Bone Graft Substitute (K030288) Berkeley Advanced Biomaterials, INC.; Bi-OsteticTM (K023703)…
Osteobiologics, Inc.2003—
*K023703BI-Ostetic
Summary page 1
…ynthetic Cancellous Bone Void Filler (K032409) OsteoBiologics, Inc.; PolyGraftTM BGS; Bone Graft Substitute (K030288) Berkeley Advanced Biomaterials, INC.; Bi-OsteticTM (K023703) 5-1 Intended Us…
Berkeley Advanced Biomaterials, Inc.2003—

Also cleared against K980817: 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 12 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
  • None of the 7 ancestors has a recall.
  • 10 other devices also cite its predicate K980817.

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?

Comporus TM is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus TM 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 resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new bone during the healing process.

Indications for use as stated in the FDA summary.

Also cleared against K980817

10 other devices cite the same predicate.

  • K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd. · 2007
  • K063346Pro Osteon 500REbi, L.P. · 2007
  • K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004
  • K033611Calcigen -Nap Bone Void FillerBiomet, Inc. · 2004
  • K030288Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
  • K030131Ossatura BCP Bone Void FillerIsotis NV · 2003

More from Takiron Co., Ltd.

6 FDA decisions under this applicant name. See the company

  • K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd. · 2008
  • K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
  • K073311Osteotrans-OT PinTakiron Co., Ltd. · 2008
  • K073312Osteotrans-OT ScrewTakiron Co., Ltd. · 2008
  • K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007

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/K062691 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062691: Comporus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062691

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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