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 Mar 25, 2015 as substantially equivalent to K141956 (Prosidyan, Inc., 2014) and 6 other predicates after a 103-day review. Its family tree reaches back 10 generations to 1996. 31 later devices descend from it.
- Decided
- Mar 25, 2015
- Review
- 103 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K960978 (1996). 27 ancestors in all, the oldest K852682 (1985). 31 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations between
- 3 generations backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 2 generations backK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 1 generation backK132805 BG MorselsProsidyan, Inc. · 2014
- This deviceK143533 Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc. · 2015
- Descendant · cites it directly · 30 of its ownK170306 FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc. · 2017
- Descendant · 2 generations on · 29 of its ownK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- Descendant · 3 generations on · 11 of its ownK223731 NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023
- Descendant · 4 generations on · 9 of its ownK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- Descendant · 3 generations on · 4 of its ownK231076 VariLift®-C Interbody Fusion SystemWenzel Spine, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 9 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 8 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 7 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 6 generations backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 5 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 4 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 3 generations backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 2 generations backK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 1 generation backK132805 BG MorselsProsidyan, Inc. · 2014
- This deviceK143533 Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc. · 2015
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc. · 2017 · cites it directly30descendants
- K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022 · 2 generations on29descendants
- K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023 · 3 generations on11descendants
- K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated · 2023 · 4 generations on9descendants
- K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc. · 2023 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −9 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −8 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −7 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −6 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −5 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −4 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| −3 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| −2 | K112773 | Novabne Putty Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| −1 | K132805 | BG Morsels | Prosidyan, Inc. | 2014 | — |
| 0 (this device) | K143533 | Fibergraft BG Putty Bone Graft Substitute | Prosidyan, Inc. | 2015 | — |
| +1 | K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan, Inc. | 2017 | — |
| +2 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| +3 | K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | 2023 | — |
| +4 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured… | Nu Vasive, Incorporated | 2023 | — |
| +3 | K231076 | VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. | 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 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141956 | Fibergraft BG MorselsSummary page 4…orbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV Predicate Devices x Prosidyan, Inc.’s FIBERGRAFT™ BG Morsels Bone Graft Substitute (K141956, K132805). x NovaBone Products, LLC’s NovaBone Putty- Bioactive Synthetic Bone Graft (K06072… | 2014 |
| * | K132805 | BG MorselsSummary page 4…one Void Filler, 21 CFR 888.3045, product code MQV Predicate Devices x Prosidyan, Inc.’s FIBERGRAFT™ BG Morsels Bone Graft Substitute (K141956, K132805). x NovaBone Products, LLC’s NovaBone Putty- Bioactive Synthetic Bone Graft (K060728, K080009, K101860, K… | 2014 |
| * | K060728 | Novabone Putty - Bioactive Synthetic GraftSummary page 4…AFT™ BG Morsels Bone Graft Substitute (K141956, K132805). x 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… | 2006 |
| * | K080009 | Novabone Putty- Bioactive Synthetic GraftSummary page 4…orsels Bone Graft Substitute (K141956, K132805). x 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 indicate… | 2008 |
| * | K101860 | Novabone Putty- Bioactive Synthetic Bone GraftSummary page 4…ne Graft Substitute (K141956, K132805). x 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…Substitute (K141956, K132805). x 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…e (K141956, K132805). x 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? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | 2017 | 30 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K170306 (Prosidyan, Inc., 2017) has gone furthest, with 30 descendants of its own.
- 2 other devices also cite its predicate K141956.
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. 2015, 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 Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the 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…
Read the full statement (110 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 Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the 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 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 as stated in the FDA summary.
https://510kreport.com/device/K143533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143533: Fibergraft BG Putty Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143533
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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