510(k) · Cleared
ClearedUltrafuse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · MQV Filler, Bone Void, Calcium Compound
Cleared on Apr 8, 2014 as substantially equivalent to K071206 (Apatech, Ltd., 2007) and 2 other predicates after a 403-day review. Its family tree reaches back 5 generations to 1996. 7 later devices descend from it.
- Decided
- Apr 8, 2014
- Review
- 403 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K960978 (1996). 10 ancestors in all. 7 later devices descend 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 backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 2 generations backK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- 1 generation backK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
- This deviceK130531 UltrafuseBaxter Healthcare Corp · 2014
- Descendant · cites it directly · 6 of its ownK181225 AltaporeBaxter Healthcare Corporation · 2018
- Descendant · 2 generations on · 4 of its ownK192363 AltaporeBaxter Healthcare Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK191513 Altapore ShapeBaxter Healthcare Corporation · 2019
- Descendant · 3 generations on · 1 of its ownK201464 Altapore MISBaxter Healthcare Corporation · 2020
- Descendant · 3 generations on · 1 of its ownK200640 Altapore ShapeBaxter Healthcare Corporation · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K181225AltaporeBaxter Healthcare Corporation · 2018 · cites it directly6descendants
- K192363AltaporeBaxter Healthcare Corporation · 2020 · 2 generations on4descendants
- K191513Altapore ShapeBaxter Healthcare Corporation · 2019 · 2 generations on2descendants
- K201464Altapore MISBaxter Healthcare Corporation · 2020 · 3 generations on1descendant
- K200640Altapore ShapeBaxter Healthcare Corporation · 2020 · 3 generations on1descendant
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 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −2 | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −1 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
| 0 (this device) | K130531 | Ultrafuse | Baxter Healthcare Corp | 2014 | — |
| +1 | K181225 | Altapore | Baxter Healthcare Corporation | 2018 | — |
| +2 | K192363 | Altapore | Baxter Healthcare Corporation | 2020 | — |
| +2 | K191513 | Altapore Shape | Baxter Healthcare Corporation | 2019 | — |
| +3 | K201464 | Altapore MIS | Baxter Healthcare Corporation | 2020 | — |
| +3 | K200640 | Altapore Shape | Baxter Healthcare Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteSummary page 1…Controls per 21 CFR888.3045 Class: Class 11 Product Code: MQV PREDICATE K071206 ABX E-Z-fil Putty Bone Graft Substitute Actifuse®& DEVICES… | 2007 |
| * | K081979 | Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft SubstituteSummary page 1…K071206 ABX E-Z-fil Putty Bone Graft Substitute Actifuse®& DEVICES K08 1979 Actifuiseg Bone Graft Substitute Actifuisc® ABX E-Z-fil Putty Bone Graft Su… | 2008 |
| * | K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft SubstitutesSummary page 1…Actifuise®& Flow Bone Graft Substitute K082575 Actifuiseg Bone Graft Substitute Actifuise® Microgranules Bone Graft Substit… | 2008 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181225 | Altapore | 2018 | 6 |
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 5 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K181225 (Baxter Healthcare Corporation, 2018) has gone furthest, with 6 descendants of its own.
- 11 other devices also cite its predicate K071206.
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?
ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130531: Ultrafuse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130531
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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