510(k) · Cleared
ClearedPore-SI Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apatech, Ltd. · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 4, 2004 as substantially equivalent to K030131 (Isotis NV, 2003) and 1 other predicate after a 202-day review. Its family tree reaches back 3 generations to 1996. 113 later devices descend from it.
- Decided
- Aug 4, 2004
- Review
- 202 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960978 (1996). 6 ancestors in all. 113 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 1 generation backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- This deviceK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- Descendant · cites it directly · 111 of its ownK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
- Descendant · 2 generations on · 79 of its ownK080736 Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008
- Descendant · 3 generations on · 76 of its ownK151584 AttraX PuttyProgentix Orthobiology BV · 2015
- Descendant · 3 generations on · 71 of its ownK191974 NuVasive AttraX PuttyNu Vasive, Incorporated · 2019
- Descendant · 4 generations on · 66 of its ownK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K071206Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · cites it directly111descendants
- K080736Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008 · 2 generations on79descendants
- K151584AttraX PuttyProgentix Orthobiology BV · 2015 · 3 generations on76descendants
- K191974NuVasive AttraX PuttyNu Vasive, Incorporated · 2019 · 3 generations on71descendants
- K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated · 2021 · 4 generations on66descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −2 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −1 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| 0 (this device) | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| +1 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
| +2 | K080736 | Actifuse Shape Bone Graft Substitute | Apatech, Ltd. | 2008 | — |
| +3 | K151584 | AttraX Putty | Progentix Orthobiology BV | 2015 | — |
| +3 | K191974 | NuVasive AttraX Putty | Nu Vasive, Incorporated | 2019 | — |
| +4 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar… | Nu Vasive, Incorporated | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 13 | 0 |
| 2024 | 25 | 0 |
| 2025 | 20 | 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? (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 |
|---|---|---|---|
| * | K030131 | Ossatura BCP Bone Void FillerSummary page 1…T Isotis NV OsSatura M BCP Bone Void Filler Isotis S.A. K030131 - cleared May 20, 2003 Skelite TM Synthetic Resorbable Bone Void… | 2003 |
| * | K011726 | Millenium's Skelite Synthetic Resorbable Bone Void FillerSummary page 1…1 - cleared May 20, 2003 Skelite TM Synthetic Resorbable Bone Void Filler (K011726), Milleniurn Biologix, Inc. - cleared May 16, 2002 Intended use: Pore-Si is a… | 2002 |
What descends from it? (113)
See all 1133 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 8 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K071206 (Apatech, Ltd., 2007) has gone furthest, with 111 descendants of its own.
- 5 other devices also cite its predicate K030131.
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.
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?
Pore-Si is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Pore-Si is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040082 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040082: Pore-SI Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040082
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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