510(k) · Cleared
ClearedTactoset® Injectable Bone Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anika Therapeutics, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 20, 2023 as substantially equivalent to K212083 (Anika Therapeutics, Inc., 2021) and 2 other predicates after a 170-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Dec 20, 2023
- Review
- 170 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K960978 (1996). 141 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 15 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 11 generations between
- 3 generations backK190956 SCS 17-01Anika Therapeutics, Inc. · 2020
- 2 generations backK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- 1 generation backK223915 TactosetAnika Therapeutics, Inc. · 2023
- This deviceK231968 Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc. · 2023
Show all 15 generations
- Root · 15 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 14 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 13 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 12 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 11 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 10 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 9 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 8 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 7 generations backK093447 CarrigenEtex Corp. · 2010
- 6 generations backK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- 5 generations backK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
- 4 generations backK173008 SCS 17-01Anika Therapeutics, Inc. · 2017
- 3 generations backK190956 SCS 17-01Anika Therapeutics, Inc. · 2020
- 2 generations backK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- 1 generation backK223915 TactosetAnika Therapeutics, Inc. · 2023
- This deviceK231968 Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −14 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −13 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −12 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −11 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −10 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −9 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −8 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| −7 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| −6 | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
| −5 | K130392 | Kinex Bioactive | Globus Medical, Inc. | 2013 | — |
| −4 | K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017 | — |
| −3 | K190956 | SCS 17-01 | Anika Therapeutics, Inc. | 2020 | — |
| −2 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| −1 | K223915 | Tactoset | Anika Therapeutics, Inc. | 2023 | — |
| 0 (this device) | K231968 | Tactoset® Injectable Bone Substitute | Anika Therapeutics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 14 | 0 |
| 2002 | 12 | 0 |
| 2003 | 13 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 12 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K212083 | Tactoset Injectable Bone SubstituteSummary page 5…80.3045, Resorbable calcium salt bone void filler device Class: II Product Codes: MQV Primary Predicate: Tactoset (K212083) Additional Predicates: Tactoset (K223915) Cerament Bone Void Filler (K201535) Indicati… | 2021 |
| * | K223915 | TactosetSummary page 5…evice Class: II Product Codes: MQV Primary Predicate: Tactoset (K212083) Additional Predicates: Tactoset (K223915) Cerament Bone Void Filler (K201535) Indications For Use: Tactoset® Injectable Bone Substitute i… | 2023 |
| * | K201535 | Cerament Bone Void FillerSummary page 5…MQV Primary Predicate: Tactoset (K212083) Additional Predicates: Tactoset (K223915) Cerament Bone Void Filler (K201535) Indications For Use: Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that ha… | 2020 |
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 27 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 11 of the 141 ancestors have a recall of any class.
- 1 other device also cites its predicate K212083.
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. 2023, 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?
Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically-created osseous defects or defects created from traumatic injury to the bone.…
Read the full statement (129 words)
Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically-created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.
Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231968: Tactoset® Injectable Bone Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231968
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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