510(k) Report

510(k) · Cleared

Cleared

Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015

K081758510(k) TraditionalCleared Sep 3, 200875-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

Depuy Spine, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Sep 3, 2008 as substantially equivalent to K012751 (Orquest, Inc., 2001) and 5 other predicates after a 75-day review. Its family tree reaches back 6 generations to 1996.

Decided
Sep 3, 2008
Review
75 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K960978 (1996). 21 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2003: 3 other ancestors2001: 3 other ancestors2004: 1 other ancestor2002: 3 other ancestors2000: 1 other ancestor1999: 1 other ancestor1998: 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. · 1998K000515 · Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, · Interpore Cross Intl. · 2000K012751 · Healos Bone Graft Material · Orquest, Inc. · 2001K043308 · Modification to: Healos Bone Graft Material · Depuy Spine, Inc. · 2005K062495 · Healos FX Bone Graft Substitute and Graft Mixing and Delivery System · Depuy Spine, Inc. · 20061995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 9 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor K062495 · Healos FX Bone Graft Substitute and Graft Mixing and Delivery System · Depuy Spine, Inc. · 2006K043308 · Modification to: Healos Bone Graft Material · Depuy Spine, Inc. · 2005K012751 · Healos Bone Graft Material · Orquest, Inc. · 2001K000515 · Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, · Interpore Cross Intl. · 2000K980817 · 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 · 6 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 5 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. 4 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
  4. 3 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
  5. 2 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
  6. 1 generation backK062495 Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc. · 2006
  7. This deviceK081758 Healos FX Injectable Bone Graft Replacement, Models 276175002…Depuy Spine, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−5K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
−4K000515Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101…Interpore Cross Intl.2000—
−3K012751Healos Bone Graft MaterialOrquest, Inc.2001—
−2K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.2005—
−1K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.2006—
0 (this device)K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005…Depuy Spine, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200010
200130
200230
200330
200410
200510
FIG. 1 — Lineage of K081758, 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? (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
*K012751Healos Bone Graft Material
Summary page 1
…cement HEALOS® Fx Graft Mixing and Delivery System Predicate Devices: (Material) HEALOS® Bone Graft Substitute (K012751 and K043308) HEALOS® Fx Bone Graft Substitute (K062495) (Mixing/Delivery device) HEAL…
Orquest, Inc.2001—
*K043308Modification to: Healos Bone Graft Material
Summary page 1
…HEALOS® Fx Graft Mixing and Delivery System Predicate Devices: (Material) HEALOS® Bone Graft Substitute (K012751 and K043308) HEALOS® Fx Bone Graft Substitute (K062495) (Mixing/Delivery device) HEALOS® Fx Graft…
Depuy Spine, Inc.2005—
*K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery System
Summary page 1
…dicate Devices: (Material) HEALOS® Bone Graft Substitute (K012751 and K043308) HEALOS® Fx Bone Graft Substitute (K062495) (Mixing/Delivery device) HEALOS® Fx Graft Mixing and Delivery System (K062495)…
Depuy Spine, Inc.2006—
*K003286Symphony Graft Delivery System
Summary page 1
…vice) HEALOS® Fx Graft Mixing and Delivery System (K062495) Symphony® Graft Delivery System (K003286) Harvest® Graft Delivery System (K043261) Imbibe® II Syringe…
Depuyacromed2001—
*K043261Harvest Graft Delivery Syringe
Summary page 1
…(K062495) Symphony® Graft Delivery System (K003286) Harvest® Graft Delivery System (K043261) Imbibe® II Syringe (K030208) DePuy Spine, Inc. Traditional 510(k) Submission…
Harvest Technologies, Corp.20052
*K030208Imbibe II Syringe
Summary page 1
…ymphony® Graft Delivery System (K003286) Harvest® Graft Delivery System (K043261) Imbibe® II Syringe (K030208) DePuy Spine, Inc. Traditional 510(k) Submission Page 5-1 Device Descript…
Orthovita, Inc.2003—

Also cleared against K012751: 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 5 companies; a new generation was cleared every 2.0 years on median.
  • 2 of the 21 ancestors have a recall of any class.
  • 10 other devices also cite its predicate K012751.

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?

HEALOS ® Fx Injectable Bone Graft Replacement ("HEALOS Fx"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS Fx is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.

The HEALOS® Fx Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® Fx Injectable Bone Graft Replacement to a surgical site.

Indications for use as stated in the FDA summary.

Also cleared against K012751

10 other devices cite the same predicate.

  • K141725Bongold Bone Graft MaterialBeijing Allgens Medical Science & Technology Co, L · 2015
  • K081432Healos II Bone Graft SubstituteDepuy Spine, Inc. · 2008
  • K071813Mastergraft PuttyMedtronic Sofamor Danek · 2007
  • K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc. · 2006
  • K051047Colloss E Bone Void FillerOssacur AG · 2006
  • K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006

More from Depuy Spine, Inc.

86 FDA decisions under this applicant name. See the company

  • K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
  • K142185Expedium Verse Spine SystemDepuy Spine, Inc. · 2014
  • K111136Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 20121 recall
  • K121020Viper SystemDepuy Spine, Inc. · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011

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/K081758 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081758: Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081758

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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