510(k) · Cleared
ClearedOsteoFlo® HydroPutty™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SurGenTec, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 2, 2023 as substantially equivalent to K110368 (Novabone Products, LLC, 2011) and 1 other predicate after a 111-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Oct 2, 2023
- Review
- 111 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K960978 (1996). 25 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations between
- 3 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 2 generations backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 1 generation backK200064 OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC · 2020
- This deviceK231716 OsteoFlo® HydroPutty™SurGenTec, LLC · 2023
Show all 9 generations
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 8 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 7 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 6 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 5 generations backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 4 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 3 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 2 generations backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 1 generation backK200064 OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC · 2020
- This deviceK231716 OsteoFlo® HydroPutty™SurGenTec, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −8 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −7 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −6 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −5 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −4 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −3 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| −2 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| −1 | K200064 | OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft | SurGenTec, LLC | 2020 | — |
| 0 (this device) | K231716 | OsteoFlo® HydroPutty™ | SurGenTec, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
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 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110368 | Novabone Putty - Bioactive Synthetic Bone GraftSummary page 4…45: Resorbable calcium salt bone void filler device Product Codes: MQV Primary Predicate: NovaBone Putty (K110368) Additional Predicate: OsteoFlo NanoPutty (K200064) Indications For Use: OsteoFlo® HydroPutty™ is indicated to fill b… | 2011 |
| * | K200064 | OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSummary page 4…filler device Product Codes: MQV Primary Predicate: NovaBone Putty (K110368) Additional Predicate: OsteoFlo NanoPutty (K200064) Indications For Use: OsteoFlo® HydroPutty™ is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities… | 2020 |
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 27 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 25 ancestors has a recall of any class.
- 6 other devices also cite its predicate K110368.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
OsteoFlo® HydroPutty™ is indicated for bony voids or gaps of the skeletal system (i.e., the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231716: OsteoFlo® HydroPutty™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231716
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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