510(k) · Cleared
ClearedCarrigen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etex Corp. · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 18, 2010 as substantially equivalent to K062630 (Etex Corp., 2007) and 2 other predicates after a 105-day review. Its family tree reaches back 8 generations to 1996. 21 later devices descend from it.
- Decided
- Feb 18, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K960978 (1996). 37 ancestors in all. 21 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 6 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 5 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 4 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 3 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 2 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 1 generation backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- This deviceK093447 CarrigenEtex Corp. · 2010
- Descendant · cites it directly · 10 of its ownK101557 Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010
- Descendant · cites it directly · 9 of its ownK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK102528 N-Force Fixation SystemInnovision, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK173008 SCS 17-01Anika Therapeutics, Inc. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010 · cites it directly10descendants
- K103799Inqu Paste Mix PlusIsto Technologies, Inc. · 2011 · cites it directly9descendants
- K130392Kinex BioactiveGlobus Medical, Inc. · 2013 · 2 generations on8descendants
- K102528N-Force Fixation SystemInnovision, Inc. · 2011 · 2 generations on5descendants
- K173008SCS 17-01Anika Therapeutics, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −7 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −6 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −5 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −4 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −3 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −2 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −1 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| 0 (this device) | K093447 | Carrigen | Etex Corp. | 2010 | — |
| +1 | K101557 | Gamma-BSM, Beta-BSM, Equivabone, Carigen | Etex Corp. | 2010 | — |
| +1 | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
| +2 | K130392 | Kinex Bioactive | Globus Medical, Inc. | 2013 | — |
| +2 | K102528 | N-Force Fixation System | Innovision, Inc. | 2011 | — |
| +3 | K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K062630 | Ossipro Bone Substitute MaterialSummary page 1…Calcium Compound (21 CFR 888.3045) Proprietary Name: CarriGen® Porous Bone Substitute Material Predicate Device(s): OssiPro (ETEX Corp., K062630) EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corp… | 2007 |
| * | K090855 | Equivabone Osteoinductive Bone Graft SubstituteSummary page 1…ce(s): OssiPro (ETEX Corp., K062630) EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corp., K090855) G~amma-bsm Moldable Bone Substitute Material (ETEX Corp.,… | 2009 |
| * | K091607 | Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneSummary page 1…Corp., K090855) G~amma-bsm Moldable Bone Substitute Material (ETEX Corp., K09 1607) Device Description: CarriGen Porous Bone Substitute Material is a synthetic, biocom… | 2009 |
What descends from it? (21)
See all 214 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 14 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 37 ancestors have a recall of any class.
- Of its descendants, K101557 (Etex Corp., 2010) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K062630.
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. 2010, 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?
CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093447 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093447: Carrigen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093447
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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