510(k) · Cleared
ClearedKainos+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 28, 2009 as substantially equivalent to K020986 (Medtronic Sofamor Danek, Inc., 2002) and 4 other predicates after a 223-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Sep 28, 2009
- Review
- 223 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K960978 (1996). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 4 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 3 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 2 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 1 generation backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- This deviceK090387 Kainos+Signus Medizintechnik GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −5 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −4 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −3 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −2 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −1 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| 0 (this device) | K090387 | Kainos+ | Signus Medizintechnik GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (5)
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 |
|---|---|---|---|
| * | K020986 | Mastergraft Resorbable CeramicSummary page 1…alence: substantially equivalent to previously cleared devices. These include: MasterGraft TM (Medtronic Sofamor Danek USA - K020986), MCBPTM (Biomatlante - K032268), PLEXUR P (Osteotech, Inc. - K08051 1) and… | 2002 |
| * | K032268 | MBCPSummary page 1…devices. These include: MasterGraft TM (Medtronic Sofamor Danek USA - K020986), MCBPTM (Biomatlante - K032268), PLEXUR P (Osteotech, Inc. - K08051 1) and VitossTM (Orthovita, Inc. - K0994337 and K081439).… | 2003 |
| * | K080511 | Plexur-PSummary page 1…MasterGraft TM (Medtronic Sofamor Danek USA - K020986), MCBPTM (Biomatlante - K032268), PLEXUR P (Osteotech, Inc. - K08051 1) and VitossTM (Orthovita, Inc. - K0994337 and K081439). The substantial… | 2008 |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler Our reading of the summary gave K094337, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Vitoss”. | 2000 |
| * | K081439 | Vitoss Bioactive Foam Pack Bone Graft SubstituteSummary page 1…(Biomatlante - K032268), PLEXUR P (Osteotech, Inc. - K08051 1) and VitossTM (Orthovita, Inc. - K0994337 and K081439). The substantial equivalence is based upon equivalence in material, basic design/size,… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 20 ancestors have a recall of any class.
- 8 other devices also cite its predicate K020986.
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. 2009, 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?
KAINOS®+ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. KAINOS®+ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, KAINOS®+ gradually resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090387: Kainos+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090387
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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