510(k) · Cleared
ClearedCalcigen Psi Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 26, 2003 as substantially equivalent to K013072 (Synthes, 2002) and 8 other predicates after a 40-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Feb 26, 2003
- Review
- 40 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 3 generations to K960978 (1996). 12 ancestors in all. 3 later devices descend from it, 2 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 backK013960 Apatight HA-Bone Graft SubstituteCerabio, LLC · 2002
- This deviceK030178 Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK032286 Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK063346 Pro Osteon 500REbi, L.P. · 2007
- Descendant · cites it directly · 0 of its ownK050490 Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea · 2005
Most influential descendants
Showing 3 of 3 · See allView 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 | K013960 | Apatight HA-Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| 0 (this device) | K030178 | Calcigen Psi Bone Graft Substitute | Biomet, Inc. | 2003 | — |
| +1 | K032286 | Calcigen Psi Bone Graft Substitute | Biomet Orthopedics, Inc. | 2003 | — |
| +2 | K063346 | Pro Osteon 500R | Ebi, L.P. | 2007 | — |
| +1 | K050490 | Osmosys Calcium Phosphate Ceramic Bone Filler | Medicrea | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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? (10)
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 |
|---|---|---|---|
| * | K013072 | Chronos Tricalcium Prosphate (Chronos TCP) | 2002 |
| * | K011531 | Calcium Phosphate Granular Bone Void Filler | 2002 |
| * | K013960 | Apatight HA-Bone Graft Substitute | 2002 |
| * | K013966 | Apatight-TCP Bone Graft Substitute | 2002 |
| * | K014156 | Cerasorb Ortho | 2002 |
| * | K014053 | Conduit TCP Granules | 2002 |
| * | K011048 | BSM Bone Substitute Material | 2001 |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…Depuy Orthopaedics, Inc. KO1 IO48 Orthovita Co. 1 K994337 Interpore Cross Intl.… | 2000 |
| * | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft SubstituteSummary page 1…Interpore Cross Intl. I K990131 Device Description CalcigenTM PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 6Oy0 hydroxyapatit… | 1999 |
| * | — | Mastergraft Resorbable Ceramic Named without a submission number |
What descends from it? (3)
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 7 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K032286 (Biomet Orthopedics, Inc., 2003) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K013072.
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?
CalcigenTMPSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e,, the extremities, spine and 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 disease or traumatic iiijury to the bone. CalcigenTMPSI resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030178 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030178: Calcigen Psi 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/K030178
Report an extraction error
Are you the manufacturer?
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