510(k) · Cleared
ClearedBiosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synergy Biomedical, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jul 16, 2014 as substantially equivalent to K122868 (Synergy Biomedical, LLC, 2013) and 2 other predicates after a 105-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jul 16, 2014
- Review
- 105 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K960978 (1996). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 3 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 2 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 1 generation backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- This deviceK140844 Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK173301 BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −4 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −3 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −2 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −1 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| 0 (this device) | K140844 | Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CC | Synergy Biomedical, Inc. | 2014 | — |
| +1 | K173301 | BioSphere MIS Putty (BioSphere MIS) | Synergy Biomedical, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K122868 | Biosphere Bioactive Bone Graft PuttySummary page 1…45 Classification Panel Orthopedic Product Code MQV Device Class. Class 11 4. Predicate Device(s) BioSphere Putty (K122868) Novabone Putty - Bioactive Synthetic Graft (K080009) lnterGro DBM (K082793) 5. Device Description BioSphere Putty Bioa… | 2013 |
| * | K080009 | Novabone Putty- Bioactive Synthetic GraftSummary page 1…t Code MQV Device Class. Class 11 4. Predicate Device(s) BioSphere Putty (K122868) Novabone Putty - Bioactive Synthetic Graft (K080009) lnterGro DBM (K082793) 5. Device Description BioSphere Putty Bioactive Bone Graft (BioSphere Putty) is an osteoconductive… | 2008 |
| * | K082793 | Intergro DBMSummary page 1…V Device Class. Class 11 4. Predicate Device(s) BioSphere Putty (K122868) Novabone Putty - Bioactive Synthetic Graft (K080009) lnterGro DBM (K082793) 5. Device Description BioSphere Putty Bioactive Bone Graft (BioSphere Putty) is an osteoconductive, bioactive bone void f… | 2009 |
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 |
|---|---|---|---|
| K173301 | BioSphere MIS Putty (BioSphere MIS) | 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 18 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K173301 (Synergy Biomedical, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K122868.
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. 2014, 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?
BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140844: Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140844
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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