510(k) · Cleared
Recalled · Class II · 2018HydroSet XT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovita, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 6, 2016 as substantially equivalent to K060061 (Stryker Corp., 2006) and 1 other predicate after a 134-day review. Its family tree reaches back 9 generations to 2002. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 6, 2016
- Review
- 134 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 9 generations to K013966 (2002). 44 ancestors in all, the oldest K861369 (1986). 10 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 5 generations between
- 3 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 2 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 1 generation backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- This deviceK161447 HydroSet XTOrthovita, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK173008 SCS 17-01Anika Therapeutics, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK222063 MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK190956 SCS 17-01Anika Therapeutics, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK233566 Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 8 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 7 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 6 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 5 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- 4 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- 3 generations backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- 2 generations backK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- 1 generation backK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- This deviceK161447 HydroSet XTOrthovita, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K173008SCS 17-01Anika Therapeutics, Inc. · 2017 · cites it directly4descendants
- K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023 · cites it directly3descendants
- K190956SCS 17-01Anika Therapeutics, Inc. · 2020 · 2 generations on3descendants
- K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 2 generations on2descendants
- K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −8 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −7 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −6 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −5 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| −4 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| −3 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| −2 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| −1 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| 0 (this device) | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | — |
| +1 | K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017 | — |
| +1 | K222063 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023 | — |
| +2 | K190956 | SCS 17-01 | Anika Therapeutics, Inc. | 2020 | — |
| +2 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| +2 | K233566 | Montage-XT Settable, Resorbable Bone Putty | Orthocon, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K060061 | Stryker Injectable CementSummary page 4…21 CFR §880.5860 Product Code MQV, FMF Predicate Devices Predicate Device: Stryker Injectable Cement (K060061) ETEX MIXING AND DELIVERY SYSTEM (K141245) Device Description HydroSet XT is a se… | 2006 |
| * | K141245 | Etex Mixing and Delivery SystemSummary page 4…s Predicate Device: Stryker Injectable Cement (K060061) ETEX MIXING AND DELIVERY SYSTEM (K141245) Device Description HydroSet XT is a self-setting calcium phosphate cement. The device includes a pre-… | 2014 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2018 | Class II | Z-0678-2019 | Labeling mix-ups | Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19 |
| Nov 15, 2018 | Class II | Z-0677-2019 | Labeling mix-ups | Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 44 ancestors have a recall of any class.
- Of its descendants, K173008 (Anika Therapeutics, Inc., 2017) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K060061.
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. 2016, 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?
The Hydroset XT Mixing and Delivery System is intended to be used for the delivery of Hydroset XT to an orthopedic surgical site. HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system(i.e. extremities, craniofacial, posterolateral spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet XT is indicated only for bony voids…
Read the full statement (133 words)
The Hydroset XT Mixing and Delivery System is intended to be used for the delivery of Hydroset XT to an orthopedic surgical site.
HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system(i.e. extremities, craniofacial, posterolateral spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet XT is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
HydroSet XT cured in-situ provides an open void/gap filler that can augment provisional hardware (e.g. k-wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporarysupport medium 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/K161447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161447: HydroSet XT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161447
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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