510(k) Report

510(k) · Cleared

Cleared

Pro Osteon 500R

K063346510(k) TraditionalCleared Apr 18, 2007166-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

Ebi, L.P. · MQV Filler, Bone Void, Calcium Compound

Cleared on Apr 18, 2007 as substantially equivalent to K990131 (Interpore Cross Intl., 1999) and 6 other predicates after a 166-day review. Its family tree reaches back 5 generations to 1996.

Decided
Apr 18, 2007
Review
166 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K960978 (1996). 23 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 2 other ancestors2004: 1 other ancestor1999: 1 other ancestor2003: 3 other ancestors2002: 7 other ancestors1997: 1 other ancestor2001: 1 other ancestor2000: 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. · 1998K013960 · Apatight HA-Bone Graft Substitute · Cerabio, LLC · 2002K030178 · Calcigen Psi Bone Graft Substitute · Biomet, Inc. · 2003K032286 · Calcigen Psi Bone Graft Substitute · Biomet Orthopedics, Inc. · 20031996199820002002200420062008
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 6 other ancestors3 generations back: 7 other ancestors K032286 · Calcigen Psi Bone Graft Substitute · Biomet Orthopedics, Inc. · 2003K030178 · Calcigen Psi Bone Graft Substitute · Biomet, Inc. · 2003K013960 · Apatight HA-Bone Graft Substitute · Cerabio, LLC · 2002K980817 · 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 · 1996−50
  1. Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. 3 generations backK013960 Apatight HA-Bone Graft SubstituteCerabio, LLC · 2002
  4. 2 generations backK030178 Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003
  5. 1 generation backK032286 Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc. · 2003
  6. This deviceK063346 Pro Osteon 500REbi, L.P. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−4K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
−3K013960Apatight HA-Bone Graft SubstituteCerabio, LLC2002—
−2K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc.2003—
−1K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc.2003—
0 (this device)K063346Pro Osteon 500REbi, L.P.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200010
200110
200270
200330
200410
200520
200610
FIG. 1 — Lineage of K063346, 1996–2007Source: 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? (7)

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
*K990131Pro Osteon Implant 500R Resorbable Bone Graft Substitute
Summary page 1
…sslificartlon Name: Filler, Bone Void, Caldium Compound (888.3045) Legally Marketed Devices To Which Substantial Equivalence Is ClaImed: * Pro Osteon® SOOR - K990131/K980817 (Interpore Cross International) * Cakcigent " PSI - K032286 (Biomet Orthopedics) * Marrow Plus (M+T…
Interpore Cross Intl.1999—
*K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…
Summary page 1
…rtlon Name: Filler, Bone Void, Caldium Compound (888.3045) Legally Marketed Devices To Which Substantial Equivalence Is ClaImed: * Pro Osteon® SOOR - K990131/K980817 (Interpore Cross International) * Cakcigent " PSI - K032286 (Biomet Orthopedics) * Marrow Plus (M+Th) - KOS…
Interpore Intl.1998—
*K032286Calcigen Psi Bone Graft Substitute
Summary page 1
…keted Devices To Which Substantial Equivalence Is ClaImed: * Pro Osteon® SOOR - K990131/K980817 (Interpore Cross International) * Cakcigent " PSI - K032286 (Biomet Orthopedics) * Marrow Plus (M+Th) - KOS 1695 (Berkeley Advanced Blornaterials, Inc.) * PolyGraft'~'…
Biomet Orthopedics, Inc.2003—
*K051695Marrow Plus (M+)Berkeley Advanced Biomaterials, Inc.2005—
*K040047Polygraft BGS; Bone Graft Substitute
Summary page 1
…igent " PSI - K032286 (Biomet Orthopedics) * Marrow Plus (M+Th) - KOS 1695 (Berkeley Advanced Blornaterials, Inc.) * PolyGraft'~'/rufflock' m BGS - K040047 (OsteoBlologics, Inc.) * NBCPT m- K043005/K051774 (Biomatlante) Device Description: Pro Osteon® 50CR Resorbable Bone G…
Osteobiologics, Inc.20041
*K043005Modification to MBCP
Summary page 1
…* Marrow Plus (M+Th) - KOS 1695 (Berkeley Advanced Blornaterials, Inc.) * PolyGraft'~'/rufflock' m BGS - K040047 (OsteoBlologics, Inc.) * NBCPT m- K043005/K051774 (Biomatlante) Device Description: Pro Osteon® 50CR Resorbable Bone Graft Substitute isan osteoconductive porous implant s…
Biomatlante2005—
*K051774MBCP
Summary page 1
…w Plus (M+Th) - KOS 1695 (Berkeley Advanced Blornaterials, Inc.) * PolyGraft'~'/rufflock' m BGS - K040047 (OsteoBlologics, Inc.) * NBCPT m- K043005/K051774 (Biomatlante) Device Description: Pro Osteon® 50CR Resorbable Bone Graft Substitute isan osteoconductive porous implant sImilar I…
Biomatlante2006—

Also cleared against K990131: 17 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 11 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
  • 1 of the 23 ancestors has a recall of any class.
  • 17 other devices also cite its predicate K990131.

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. 2007, 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?

PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PRO OSTEON® 500R is indicated 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. PRO OSTEON® 500R can be combined with autogenous bone marrow aspirate, autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

Also cleared against K990131

17 other devices cite the same predicate.

  • K180853EP Granules™ BVFElute, Inc. · 2018
  • K093342Biogennix RPCBiogennix, LLC · 2010
  • K063157Merries K-Phate Bone Graft SubstituteMerries International, Inc. · 2008
  • K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd. · 2007
  • K070220Osteofix Bone Void FillerCalcitec, Inc. · 2007
  • K060432Novabone Porous-Bone Graft ScaffoldNovabone Products, LLC · 2006

More from Ebi, L.P.

101 FDA decisions under this applicant name. See the company

  • K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P. · 2010
  • K100220Polaris Spinal SystemEbi, L.P. · 2010
  • K093880Peanut Growth Control Plating SystemEbi, L.P. · 20101 recall
  • K092574Esl Spinal SystemEbi, L.P. · 2010
  • K093057Biomet Vision Footring SystemEbi, L.P. · 2009

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/K063346 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063346: Pro Osteon 500R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063346

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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