510(k) · Cleared
ClearedAltapore
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 31, 2018 as substantially equivalent to K140375 (Medtronic Sofamor Danek USA, Inc., 2014) and 1 other predicate after a 115-day review. Its family tree reaches back 9 generations to 1996. 6 later devices descend from it.
- Decided
- Aug 31, 2018
- Review
- 115 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K960978 (1996). 41 ancestors in all, the oldest K871773 (1987). 6 later devices descend from it, 2 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 deviceK181225 AltaporeBaxter Healthcare Corporation · 2018
- Descendant · cites it directly · 4 of its ownK192363 AltaporeBaxter Healthcare Corporation · 2020
- Descendant · cites it directly · 2 of its ownK191513 Altapore ShapeBaxter Healthcare Corporation · 2019
- Descendant · 2 generations on · 1 of its ownK201464 Altapore MISBaxter Healthcare Corporation · 2020
- Descendant · 2 generations on · 1 of its ownK200640 Altapore ShapeBaxter Healthcare Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK241564 Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE…Baxter Healthcare Corporation · 2024
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 deviceK181225 AltaporeBaxter Healthcare Corporation · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192363AltaporeBaxter Healthcare Corporation · 2020 · cites it directly4descendants
- K191513Altapore ShapeBaxter Healthcare Corporation · 2019 · cites it directly2descendants
- K201464Altapore MISBaxter Healthcare Corporation · 2020 · 2 generations on1descendant
- K200640Altapore ShapeBaxter Healthcare Corporation · 2020 · 2 generations on1descendant
- K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation · 2024 · 2 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) | K181225 | Altapore | Baxter Healthcare Corporation | 2018 | — |
| +1 | K192363 | Altapore | Baxter Healthcare Corporation | 2020 | — |
| +1 | K191513 | Altapore Shape | Baxter Healthcare Corporation | 2019 | — |
| +2 | K201464 | Altapore MIS | Baxter Healthcare Corporation | 2020 | — |
| +2 | K200640 | Altapore Shape | Baxter Healthcare Corporation | 2020 | — |
| +2 | K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE… | Baxter Healthcare Corporation | 2024 | — |
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 |
| 2008 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 5…Device Company Predicate 510(k) Clearance Date ® MASTERGRAFT Medtronic Sofamor K140375 April 18, 2014 Putty Danek USA, Inc. (Primary predicate) ULTRAFUSEa Baxt… | 2014 |
| * | K130531 | UltrafuseSummary page 5…K140375 April 18, 2014 Putty Danek USA, Inc. (Primary predicate) ULTRAFUSEa Baxter Healthcare K130531 April 8, 2014 (Secondary predicate) Corporation a Device name changed to ALTAPORE during FDA review of K13… | 2014 |
What descends from it? (6)
2 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)
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 22 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 41 ancestors have a recall of any class.
- Of its descendants, K192363 (Baxter Healthcare Corporation, 2020) has gone furthest, with 4 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. 2018, 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, pelvis and posterolateral spine). ALTAPORE may be used with autograft as a bone graft extender or bone marrow aspirate in
extremities, and pelvis. ALTAPORE must be used in combination with autograft as a bone graft extender or autogenous bone marrow aspirate in posterolateral spinal fusion procedures. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181225: Altapore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181225
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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