510(k) · Cleared
ClearedPro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 15, 2000 as substantially equivalent to K980817 (Interpore Intl., 1998) after a 212-day review. Its family tree reaches back 2 generations to 1996. 85 later devices descend from it.
- Decided
- Sep 15, 2000
- Review
- 212 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960978 (1996). 3 ancestors in all. 85 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 1 generation backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- This deviceK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- Descendant · cites it directly · 84 of its ownK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- Descendant · 2 generations on · 67 of its ownK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- Descendant · 2 generations on · 59 of its ownK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- Descendant · cites it directly · 54 of its ownK033679 Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004
- Descendant · 2 generations on · 47 of its ownK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K012751Healos Bone Graft MaterialOrquest, Inc. · 2001 · cites it directly84descendants
- K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005 · 2 generations on67descendants
- K051386Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005 · 2 generations on59descendants
- K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004 · cites it directly54descendants
- K071813Mastergraft PuttyMedtronic Sofamor Danek · 2007 · 2 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −1 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| 0 (this device) | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| +1 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| +2 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| +2 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| +1 | K033679 | Copsios Bone Void Filler (BVF) | Centerpulse Spine-Tech, Inc. | 2004 | — |
| +2 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…Summary page 1…Substitute PREDICATE DEVICE Interpore Cross International's Pro Osteon 5008 Resorbable Bone Graft Substitute [reference 510(k) K980817] This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements… | 1998 |
What descends from it? (85)
See all 852 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 4 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K012751 (Orquest, Inc., 2001) has gone furthest, with 84 descendants of its own.
- 10 other devices also cite its predicate K980817.
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?
Pro Osteon® 2008 Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 2008 is indicated to be gently packed into bony voids or gaps of the 'skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Theproduct provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K000515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000515: Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000515
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026