510(k) · Cleared
ClearedFIBERGRAFT BG Matrix 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 Jun 30, 2017 as substantially equivalent to K103173 (Orthovita, Inc., 2011) after a 60-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Jun 30, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K960978 (1996). 32 ancestors in all, the oldest K852682 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 6 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 5 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 4 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 3 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 2 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 1 generation backK103173 Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc. · 2011
- This deviceK171284 FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK182670 FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −7 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −6 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −5 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −4 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −3 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −2 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −1 | K103173 | Vitoss BA Bimodal Bioactive Bone Graft Substitute | Orthovita, Inc. | 2011 | — |
| 0 (this device) | K171284 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | 2017 | — |
| +1 | K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute | Prosidyan, Inc. | 2018 | — |
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 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (1)
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 |
|---|---|---|---|
| * | K103173 | Vitoss BA Bimodal Bioactive Bone Graft SubstituteSummary page 4…ation/Product Code Resorbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV Predicate Device • Stryker/Orthovita Inc, Vitoss Bioactive Bimodal (K103173) Reference Device • NovaBone Products LLC, Novabone MacroFORM (K140946) Intended Use / Indications for Use FIBERGRAFT® B… | 2011 |
| † | K140946 | Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive Composite | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute | 2018 | 0 |
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 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 32 ancestors have a recall of any class.
- Of its descendants, K182670 (Prosidyan, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K103173.
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 Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). 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 Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171284: FIBERGRAFT BG Matrix 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/K171284
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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