510(k) · Cleared
ClearedFIBERGRAFT BG Putty Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosidyan, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on May 24, 2017 as substantially equivalent to K151154 (Prosidyan, Inc., 2015) and 8 other predicates after a 113-day review. Its family tree reaches back 11 generations to 1996. 30 later devices descend from it.
- Decided
- May 24, 2017
- Review
- 113 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 11 generations to K960978 (1996). 29 ancestors in all, the oldest K852682 (1985). 30 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations between
- 3 generations backK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 2 generations backK132805 BG MorselsProsidyan, Inc. · 2014
- 1 generation backK143533 Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc. · 2015
- This deviceK170306 FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc. · 2017
- Descendant · cites it directly · 29 of its ownK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- Descendant · 2 generations on · 11 of its ownK223731 NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023
- Descendant · 3 generations on · 9 of its ownK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- Descendant · 2 generations on · 4 of its ownK231076 VariLift®-C Interbody Fusion SystemWenzel Spine, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
Show all 11 generations
- Root · 11 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 10 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 9 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 8 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 7 generations backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 6 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 5 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 4 generations backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 3 generations backK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 2 generations backK132805 BG MorselsProsidyan, Inc. · 2014
- 1 generation backK143533 Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc. · 2015
- This deviceK170306 FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc. · 2017
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022 · cites it directly29descendants
- K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023 · 2 generations on11descendants
- K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated · 2023 · 3 generations on9descendants
- K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc. · 2023 · 2 generations on4descendants
- K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine · 2025 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −10 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −9 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −8 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −7 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −6 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −5 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| −4 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| −3 | K112773 | Novabne Putty Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| −2 | K132805 | BG Morsels | Prosidyan, Inc. | 2014 | — |
| −1 | K143533 | Fibergraft BG Putty Bone Graft Substitute | Prosidyan, Inc. | 2015 | — |
| 0 (this device) | K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan, Inc. | 2017 | — |
| +1 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| +2 | K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | 2023 | — |
| +3 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured… | Nu Vasive, Incorporated | 2023 | — |
| +2 | K231076 | VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. | 2023 | — |
| +2 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System… | Alphatec Spine | 2025 | — |
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 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 13 | 0 |
| 2026 | 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.
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? (9)
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 |
|---|---|---|---|
| * | K151154 | FIBERGRAFT BG MorselsSummary page 4…de Resorbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV Predicate Devices • Prosidyan, Inc.’s FIBERGRAFT® BG Morsels Bone Graft Substitute (K151154, K141956, K132805) (Primary Predicate) • Prosidyan, Inc.’s FIBERGRAFT® BG Putty Bone Graft Substitute (K143533)… | 2015 |
| * | K141956 | Fibergraft BG MorselsSummary page 4…orbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV Predicate Devices • Prosidyan, Inc.’s FIBERGRAFT® BG Morsels Bone Graft Substitute (K151154, K141956, K132805) (Primary Predicate) • Prosidyan, Inc.’s FIBERGRAFT® BG Putty Bone Graft Substitute (K143533) • NovaB… | 2014 |
| * | K132805 | BG MorselsSummary page 4…alcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV Predicate Devices • Prosidyan, Inc.’s FIBERGRAFT® BG Morsels Bone Graft Substitute (K151154, K141956, K132805) (Primary Predicate) • Prosidyan, Inc.’s FIBERGRAFT® BG Putty Bone Graft Substitute (K143533) • NovaBone Produ… | 2014 |
| * | K143533 | Fibergraft BG Putty Bone Graft SubstituteSummary page 4…FIBERGRAFT® BG Morsels Bone Graft Substitute (K151154, K141956, K132805) (Primary Predicate) • Prosidyan, Inc.’s FIBERGRAFT® BG Putty Bone Graft Substitute (K143533) • NovaBone Products, LLC’s NovaBone Putty- Bioactive Synthetic Bone Graft (K060728, K080009, K101860, K110368, K112… | 2015 |
| * | K060728 | Novabone Putty - Bioactive Synthetic GraftSummary page 4…redicate) • Prosidyan, Inc.’s FIBERGRAFT® BG Putty Bone Graft Substitute (K143533) • NovaBone Products, LLC’s NovaBone Putty- Bioactive Synthetic Bone Graft (K060728, K080009, K101860, K110368, K112773) Intended Use / Indications for Use FIBERGRAFT® BG Putty - Bone Graft Substi… | 2006 |
| * | K080009 | Novabone Putty- Bioactive Synthetic GraftSummary page 4…• Prosidyan, Inc.’s FIBERGRAFT® BG Putty Bone Graft Substitute (K143533) • NovaBone Products, LLC’s NovaBone Putty- Bioactive Synthetic Bone Graft (K060728, K080009, K101860, K110368, K112773) Intended Use / Indications for Use FIBERGRAFT® BG Putty - Bone Graft Substitute is i… | 2008 |
| * | K101860 | Novabone Putty- Bioactive Synthetic Bone GraftSummary page 4…an, Inc.’s FIBERGRAFT® BG Putty Bone Graft Substitute (K143533) • NovaBone Products, LLC’s NovaBone Putty- Bioactive Synthetic Bone Graft (K060728, K080009, K101860, K110368, K112773) Intended Use / Indications for Use FIBERGRAFT® BG Putty - Bone Graft Substitute is indicated only fo… | 2010 |
| * | K110368 | Novabone Putty - Bioactive Synthetic Bone GraftSummary page 4…s FIBERGRAFT® BG Putty Bone Graft Substitute (K143533) • NovaBone Products, LLC’s NovaBone Putty- Bioactive Synthetic Bone Graft (K060728, K080009, K101860, K110368, K112773) Intended Use / Indications for Use FIBERGRAFT® BG Putty - Bone Graft Substitute is indicated only for bony vo… | 2011 |
| * | K112773 | Novabne Putty Bioactive Synthetic Bone GraftSummary page 4…AFT® BG Putty Bone Graft Substitute (K143533) • NovaBone Products, LLC’s NovaBone Putty- Bioactive Synthetic Bone Graft (K060728, K080009, K101860, K110368, K112773) Intended Use / Indications for Use FIBERGRAFT® BG Putty - Bone Graft Substitute is indicated only for bony voids or ga… | 2011 |
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | 2022 | 29 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K222276 (Depuy Spine, 2022) has gone furthest, with 29 descendants of its own.
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. 2017, 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?
FIBERGRAFT® BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Pultty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void…
Read the full statement (123 words)
FIBERGRAFT® BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Pultty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® BG Putty must be used with autograft in the posterolateral spine.
FIBERGRAFT® BG Pultty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170306: FIBERGRAFT BG Putty Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170306
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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