510(k) · Cleared
ClearedOsteoFlo HydroFiber
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 May 28, 2025 as substantially equivalent to K140375 (Medtronic Sofamor Danek USA, Inc., 2014) and 2 other predicates after a 156-day review. Its family tree reaches back 28 generations to 1984. 1 of the 439 devices in its family, counting itself, has a Class I recall.
- Decided
- May 28, 2025
- Review
- 156 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 28 generations to K841189 (1984). 438 ancestors in all. No later device cites it as a predicate yet. 1 of the 439 devices in this family, counting this one, has a Class I recall.
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations between
- 3 generations backK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- 2 generations backK240458 Synthetic Bone PuttyVentris Medical · 2024
- 1 generation backK242797 OsteoFlo HydroFiberSurGenTec, LLC · 2024
- This deviceK243949 OsteoFlo HydroFiberSurGenTec, LLC · 2025
Show all 28 generations
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 26 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 25 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 22 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 21 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 18 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 17 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 16 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 15 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 14 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 13 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 12 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 11 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 10 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 9 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 8 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 7 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 6 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 5 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 4 generations backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- 3 generations backK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- 2 generations backK240458 Synthetic Bone PuttyVentris Medical · 2024
- 1 generation backK242797 OsteoFlo HydroFiberSurGenTec, LLC · 2024
- This deviceK243949 OsteoFlo HydroFiberSurGenTec, LLC · 2025
Class I recalls in this family
- K073202 Ardis Spacer8 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −27 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −26 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −25 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −22 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −21 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −18 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −17 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −16 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −15 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −14 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −13 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −12 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −11 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −10 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −9 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −8 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −5 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −4 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar… | Nu Vasive, Incorporated | 2021 | — |
| −3 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| −2 | K240458 | Synthetic Bone Putty | Ventris Medical | 2024 | — |
| −1 | K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024 | — |
| 0 (this device) | K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 16 | 0 |
| 2002 | 16 | 0 |
| 2003 | 25 | 0 |
| 2004 | 32 | 0 |
| 2005 | 33 | 0 |
| 2006 | 12 | 0 |
| 2007 | 22 | 0 |
| 2008 | 49 | 1 |
| 2009 | 31 | 0 |
| 2010 | 22 | 0 |
| 2011 | 29 | 0 |
| 2012 | 11 | 0 |
| 2013 | 16 | 0 |
| 2014 | 25 | 0 |
| 2015 | 18 | 0 |
| 2016 | 6 | 0 |
| 2017 | 10 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K140375 | Mastergraft Putty, Mastergraft StripSummary page 5….3045: Resorbable Calcium Salt Bone Void Filler Class: II Product Codes: MQV Primary Predicate: MASTERGRAFT Putty (K140375) Additional Predicate: Vitoss (K163621), OsteoFlo HydroFiber (K242797) Indications For Use: OsteoFlo HydroFiber is a b… | 2014 |
| * | K163621 | Vitoss Bioactive (BA) InjectableSummary page 5…Class: II Product Codes: MQV Primary Predicate: MASTERGRAFT Putty (K140375) Additional Predicate: Vitoss (K163621), OsteoFlo HydroFiber (K242797) Indications For Use: OsteoFlo HydroFiber is a bone void filler intended for use in osseous defec… | 2017 |
| * | K242797 | OsteoFlo HydroFiberSummary page 5…II Product Codes: MQV Primary Predicate: MASTERGRAFT Putty (K140375) Additional Predicate: Vitoss (K163621), OsteoFlo HydroFiber (K242797) Indications For Use: OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 8 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 15 companies; a new generation was cleared every 10 months on median.
- 48 of the 438 ancestors have a recall of any class; 1 has a Class I recall.
- 16 other devices also cite its predicate K140375.
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. 2025, 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 HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the extremities, pelvis, posterolateral…
Read the full statement (133 words)
OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the extremities, pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, OsteoFlo HydroFiber must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243949: OsteoFlo HydroFiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243949
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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