510(k) Report

510(k) · Cleared

Cleared

Oss Bone Graft System and Oss Rapidset Bone Graft System

K041089510(k) TraditionalCleared Aug 31, 2004127-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

Biomet Manufacturing, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Aug 31, 2004 as substantially equivalent to K990290 (Biomet, Inc., 1999) and 6 other predicates after a 127-day review. Its family tree reaches back 2 generations to 1999.

Decided
Aug 31, 2004
Review
127 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K990290 (1999). 7 ancestors in all, the oldest K990131 (1999). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 3 other ancestors1999: 1 other ancestorK990290 · Craniofacial Calcium Phosphate Ceramic Bone Filler · Biomet, Inc. · 1999K012569 · Modification to: Injectable Mimix · Biomet, Inc. · 2001199619982000200220042006
Other ancestors, by generation 1 generation back: 5 other ancestors K012569 · Modification to: Injectable Mimix · Biomet, Inc. · 2001K990290 · Craniofacial Calcium Phosphate Ceramic Bone Filler · Biomet, Inc. · 19990
  1. Root · 2 generations backK990290 Craniofacial Calcium Phosphate Ceramic Bone FillerBiomet, Inc. · 1999
  2. 1 generation backK012569 Modification to: Injectable MimixBiomet, Inc. · 2001
  3. This deviceK041089 Oss Bone Graft System and Oss Rapidset Bone Graft SystemBiomet Manufacturing, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K990290Craniofacial Calcium Phosphate Ceramic Bone FillerBiomet, Inc.1999—
−1K012569Modification to: Injectable MimixBiomet, Inc.2001—
0 (this device)K041089Oss Bone Graft System and Oss Rapidset Bone Graft SystemBiomet Manufacturing, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200130
200210
FIG. 1 — Lineage of K041089, 1999–2004Source: 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
*K990290Craniofacial Calcium Phosphate Ceramic Bone Filler
Summary page 1
…FR 888.3045) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The current product is identical to the material previously cleared through 510(k)s K'990290, K012569 and K023718 for craniofacial applications and K003494 for dental applications. Products cleared for orthopedic applicat…
Biomet, Inc.1999—
*K012569Modification to: Injectable Mimix
Summary page 1
…045) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The current product is identical to the material previously cleared through 510(k)s K'990290, K012569 and K023718 for craniofacial applications and K003494 for dental applications. Products cleared for orthopedic applications incl…
Biomet, Inc.2001—
*K023718Quickset Mimix Bone Void Filler
Summary page 1
…y Marketed Devices To Which Substantial Equivalence Is Claimed: The current product is identical to the material previously cleared through 510(k)s K'990290, K012569 and K023718 for craniofacial applications and K003494 for dental applications. Products cleared for orthopedic applications include: cx-BSM®…
Walter Lorenz Surgical, Inc.2002—
*K003494Mimix Bone Replacement System
Summary page 1
…uivalence Is Claimed: The current product is identical to the material previously cleared through 510(k)s K'990290, K012569 and K023718 for craniofacial applications and K003494 for dental applications. Products cleared for orthopedic applications include: cx-BSM® Bone Substitute Material (K0l 1048), Nori…
Biomet, Inc.2001—
*K011048BSM Bone Substitute MaterialDePuy Orthopaedics, Inc.2001—
*K011897Norian SRS Bone Void Filler
Summary page 1
…s and K003494 for dental applications. Products cleared for orthopedic applications include: cx-BSM® Bone Substitute Material (K0l 1048), Norian® SRS® Bone Void Filler (K01 1897) and Pro Osteon® 500OR Resorbable Bone Graft Substitute (K990131). Device Description: OSS Bone Graft System and 055 RapidSet Bo…
Synthes (Usa)2001—
*K990131Pro Osteon Implant 500R Resorbable Bone Graft Substitute
Summary page 1
…pedic applications include: cx-BSM® Bone Substitute Material (K0l 1048), Norian® SRS® Bone Void Filler (K01 1897) and Pro Osteon® 500OR Resorbable Bone Graft Substitute (K990131). Device Description: OSS Bone Graft System and 055 RapidSet Bone Graft System are packaged as separate, pre-measured powder and…
Interpore Cross Intl.1999—

Also cleared against K990290: 4 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 5 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
  • None of the 7 ancestors has a recall.
  • 4 other devices also cite its predicate K990290.

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?

The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Indications for use as stated in the FDA summary.

Also cleared against K990290

4 other devices cite the same predicate.

  • K042516OtomimixWalter Lorenz Surgical, Inc. · 2004
  • K023718Quickset Mimix Bone Void FillerWalter Lorenz Surgical, Inc. · 2002
  • K021440Bonesource HacStryker Instruments · 2002
  • K012569Modification to: Injectable MimixBiomet, Inc. · 2001

More from Biomet Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  • K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 20084 recalls
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls

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/K041089 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041089: Oss Bone Graft System and Oss Rapidset Bone Graft System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041089

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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