510(k) · Cleared
ClearedProgenix Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 24, 2008 as substantially equivalent to K072265 (Medtronic Sofamor Danek, 2008) and 1 other predicate after a 133-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Nov 24, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K963562 (1997). 24 ancestors in all, the oldest K960978 (1996). No later device cites it as a predicate yet.
- Root · 6 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 5 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 4 generations backK040755 Exactech Resorbable Room Temperature Bone PasteExactech, Inc. · 2004
- 3 generations backK043048 Grafton Plus DBM PasteOsteotech, Inc. · 2005 · Recalled
- 2 generations backK060794 Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
- 1 generation backK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008
- This deviceK082002 Progenix PlusMedtronic Sofamor Danek · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −5 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| −4 | K040755 | Exactech Resorbable Room Temperature Bone Paste | Exactech, Inc. | 2004 | — |
| −3 | K043048 | Grafton Plus DBM Paste | Osteotech, Inc. | 2005 | 15 |
| −2 | K060794 | Progenix DBM Putty and Paste | Medtronic Sofamor Danek | 2006 | — |
| −1 | K072265 | Progenix DMB Putty | Medtronic Sofamor Danek | 2008 | — |
| 0 (this device) | K082002 | Progenix Plus | Medtronic Sofamor Danek | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 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? (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 |
|---|---|---|---|
| * | K072265 | Progenix DMB PuttySummary page 2…icles as well as a change in the amount of sodium alginate. The indications for PROGENIX® Plus will be identical to the previously cleared PROGENIX® product (K072265, SE 01/09108). IV. Indications PROGENIX® Plus is intended for use as a bone graft substitute in bony voids or gaps… | 2008 |
| * | K051195 | Grafton DBMSummary page 2…to previously cleared bone void fillers such as PROGENIX® DBM Putty (Medtronic Sofamor Danek, K072265, SE 01/09/08)and GRAFTON® DBM Crunch (Osteotech, Inc., K051195, SE 12/16/05). VI. Osteoinductivity Potential All DBM used in the preparation of PROGENIX® Plus must induce bone f… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K072265.
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. 2008, 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?
PROGENIX® Plus is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (i.e. spine, pelvis and extremities). The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® Plus provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. The device may either be use alone or mixed with autograft bone and used as a bone graft extender.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082002 · printed Nov 3, 2026
Cite this page
510(k) Report. “K082002: Progenix Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K082002
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