510(k) · Cleared
ClearedNuVasive AttraX Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 3, 2019 as substantially equivalent to K151584 (Progentix Orthobiology BV, 2015) and 3 other predicates after a 102-day review. Its family tree reaches back 7 generations to 1996. 71 later devices descend from it.
- Decided
- Nov 3, 2019
- Review
- 102 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K960978 (1996). 13 ancestors in all. 71 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 5 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 4 generations backK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- 3 generations backK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
- 2 generations backK080736 Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008
- 1 generation backK151584 AttraX PuttyProgentix Orthobiology BV · 2015
- This deviceK191974 NuVasive AttraX PuttyNu Vasive, Incorporated · 2019
- Descendant · cites it directly · 66 of its ownK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- Descendant · 2 generations on · 29 of its ownK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- Descendant · 2 generations on · 11 of its ownK223731 NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023
- Descendant · 3 generations on · 9 of its ownK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- Descendant · 2 generations on · 7 of its ownK232315 Catalyst Bone Void FillerOssdsign AB · 2023
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated · 2021 · cites it directly66descendants
- K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022 · 2 generations on29descendants
- K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023 · 2 generations on11descendants
- K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated · 2023 · 3 generations on9descendants
- K232315Catalyst Bone Void FillerOssdsign AB · 2023 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −6 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −5 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −4 | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −3 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
| −2 | K080736 | Actifuse Shape Bone Graft Substitute | Apatech, Ltd. | 2008 | — |
| −1 | K151584 | AttraX Putty | Progentix Orthobiology BV | 2015 | — |
| 0 (this device) | K191974 | NuVasive AttraX Putty | Nu Vasive, Incorporated | 2019 | — |
| +1 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar… | Nu Vasive, Incorporated | 2021 | — |
| +2 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| +2 | K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | 2023 | — |
| +3 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured… | Nu Vasive, Incorporated | 2023 | — |
| +2 | K232315 | Catalyst Bone Void Filler | Ossdsign AB | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 13 | 0 |
| 2024 | 24 | 0 |
| 2025 | 19 | 0 |
| 2026 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | K151584 | AttraX PuttySummary page 4…Code: MQV C. Predicate Devices The subject AttraX Putty is substantially equivalent to multiple predicate devices. Progentix AttraX Putty (K151584) serves as the primary predicate device, CuriOs (AttraX Granules) (K090641), Actifuse Shape (K080736), and the OSferion (K06… | 2015 |
| * | K090641 | CuriosSummary page 4…y is substantially equivalent to multiple predicate devices. Progentix AttraX Putty (K151584) serves as the primary predicate device, CuriOs (AttraX Granules) (K090641), Actifuse Shape (K080736), and the OSferion (K061499) serve as additional predicates. D. Device Description NuVasiv… | 2009 |
| * | K080736 | Actifuse Shape Bone Graft SubstituteSummary page 4…ent to multiple predicate devices. Progentix AttraX Putty (K151584) serves as the primary predicate device, CuriOs (AttraX Granules) (K090641), Actifuse Shape (K080736), and the OSferion (K061499) serve as additional predicates. D. Device Description NuVasive AttraX Putty is a synthe… | 2008 |
| * | K061499 | OsferionSummary page 4…vices. Progentix AttraX Putty (K151584) serves as the primary predicate device, CuriOs (AttraX Granules) (K090641), Actifuse Shape (K080736), and the OSferion (K061499) serve as additional predicates. D. Device Description NuVasive AttraX Putty is a synthetic, osteoconductive and res… | 2007 |
What descends from it? (71)
See all 713 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 23 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K203714 (Nu Vasive, Incorporated, 2021) has gone furthest, with 66 descendants of its own.
- 3 other devices also cite its predicate K151584.
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. 2019, 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?
AttraX® Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. posterolateral spine and pelvis)
and may be used in combination with autogenous bone. These osseous defects may be surgically created or the result of
traumatic injury to the bone and are not instrinsic to the stability of the bony structure. AttraX Putty resorbs and is
replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191974: NuVasive AttraX Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191974
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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