510(k) · Cleared
ClearedOsteo3 ZP Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirakoss, Ltd. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jun 9, 2020 as substantially equivalent to K140375 (Medtronic Sofamor Danek USA, Inc., 2014) and 1 other predicate after a 218-day review. Its family tree reaches back 9 generations to 1996. 4 later devices descend from it.
- Decided
- Jun 9, 2020
- Review
- 218 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K960978 (1996). 38 ancestors in all, the oldest K871773 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations between
- 3 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 2 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 1 generation backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK193075 Osteo3 ZP PuttySirakoss, Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
- Descendant · 2 generations on · 2 of its ownK233607 MagnetOs Easypack PuttyKuros Biosciences B.V · 2023
- Descendant · 3 generations on · 1 of its ownK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
- Descendant · 4 generations on · 0 of its ownK243474 MagnetOs MISKuros Biosciences B.V · 2025
Show all 9 generations
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 8 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 7 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 6 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 5 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 4 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 3 generations backK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- 2 generations backK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- 1 generation backK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK193075 Osteo3 ZP PuttySirakoss, Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · cites it directly3descendants
- K233607MagnetOs Easypack PuttyKuros Biosciences B.V · 2023 · 2 generations on2descendants
- K241212MagnetOs Easypack PuttyKuros Biosciences · 2024 · 3 generations on1descendant
- K243474MagnetOs MISKuros Biosciences B.V · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −8 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −7 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −6 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −5 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −4 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −3 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| −2 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| −1 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| 0 (this device) | K193075 | Osteo3 ZP Putty | Sirakoss, Ltd. | 2020 | — |
| +1 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +2 | K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023 | — |
| +3 | K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024 | — |
| +4 | K243474 | MagnetOs MIS | Kuros Biosciences B.V | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (2)
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 4…on Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc. Additional Predicate Device K071206, Actifuse ™ ABX E-… | 2014 |
| * | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteSummary page 4…es) PREDICATE DEVICE INFORMATION Primary Predicate Device K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc. Additional Predicate Device K071206, Actifuse ™ ABX E-Z-fil Bone Graft Substitute, ApaTech Limited Reference Device K173525, NovoGro, OsteoNovus, Inc.… | 2007 |
| † | K173525 | NovoGro | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211201 | MagnetOs Easypack Putty | 2021 | 3 |
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 24 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 38 ancestors have a recall of any class.
- Of its descendants, K211201 (Kuros Biosciences B.V, 2021) has gone furthest, with 3 descendants of its own.
- 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. 2020, 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?
Osteo3 ZP Putty is indicated for filling bone voids or defects of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or as a result of traumatic injury to the bone. Osteo3 ZP Putty is a bone graft putty that is resorbed and replaced with bone during the healing process. Osteo3 ZP Putty must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193075 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193075: Osteo3 ZP Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193075
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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