510(k) · Cleared
ClearedOssimend (TM) Bone Graft Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collagen Matrix, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jan 25, 2006 as substantially equivalent to K012751 (Orquest, Inc., 2001) and 5 other predicates after a 113-day review. Its family tree reaches back 5 generations to 1996. 40 later devices descend from it.
- Decided
- Jan 25, 2006
- Review
- 113 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K960978 (1996). 21 ancestors in all, the oldest K871773 (1987). 40 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 3 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 2 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 1 generation backK033679 Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004
- This deviceK052812 Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc. · 2006
- Descendant · cites it directly · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 30 of its ownK140375 Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK181225 AltaporeBaxter Healthcare Corporation · 2018
- Descendant · 3 generations on · 4 of its ownK193075 Osteo3 ZP PuttySirakoss, Ltd. · 2020
- Descendant · 3 generations on · 4 of its ownK192363 AltaporeBaxter Healthcare Corporation · 2020
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · cites it directly38descendants
- K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on30descendants
- K181225AltaporeBaxter Healthcare Corporation · 2018 · 3 generations on6descendants
- K193075Osteo3 ZP PuttySirakoss, Ltd. · 2020 · 3 generations on4descendants
- K192363AltaporeBaxter Healthcare Corporation · 2020 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −4 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −3 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −2 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −1 | K033679 | Copsios Bone Void Filler (BVF) | Centerpulse Spine-Tech, Inc. | 2004 | — |
| 0 (this device) | K052812 | Ossimend (TM) Bone Graft Material | Collagen Matrix, Inc. | 2006 | — |
| +1 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
| +2 | K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +3 | K181225 | Altapore | Baxter Healthcare Corporation | 2018 | — |
| +3 | K193075 | Osteo3 ZP Putty | Sirakoss, Ltd. | 2020 | — |
| +3 | K192363 | Altapore | Baxter Healthcare Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K012751 | Healos Bone Graft MaterialSummary page 1…: 888.3045 Device Class: Class II Product Code: MQV Predicate Device(s): HEALOS® Bone Graft Material, K012751 CopiOsTM Bone Void Filler, K033679 Collagraft Strip Bone Graf… | 2001 |
| * | K033679 | Copsios Bone Void Filler (BVF)Summary page 1…Product Code: MQV Predicate Device(s): HEALOS® Bone Graft Material, K012751 CopiOsTM Bone Void Filler, K033679 Collagraft Strip Bone Graft Matrix, K000122 Vitoss® Scaffold… | 2004 |
| * | K000122 | Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6…Summary page 1…® Bone Graft Material, K012751 CopiOsTM Bone Void Filler, K033679 Collagraft Strip Bone Graft Matrix, K000122 Vitoss® Scaffold Foam Bone Graft Material, K032288 ORTHOSSTM… | 2001 |
| * | K032288 | Vitoss Scaffold Foam Bone Graft MaterialSummary page 1…iller, K033679 Collagraft Strip Bone Graft Matrix, K000122 Vitoss® Scaffold Foam Bone Graft Material, K032288 ORTHOSSTM Resorbable Bone Void Filler, K014289 OsteoGuide® An… | 2003 |
| * | K014289 | Orthoss Resorbable Bone Void FillerSummary page 1…ix, K000122 Vitoss® Scaffold Foam Bone Graft Material, K032288 ORTHOSSTM Resorbable Bone Void Filler, K014289 OsteoGuide® Anorganic Bone Mineral Products, K043034 Description of the Device OssiMendTM Bo… | 2002 |
| * | K043034 | Osteoguide Anorganic Bone Mineral ProductsSummary page 1…, K032288 ORTHOSSTM Resorbable Bone Void Filler, K014289 OsteoGuide® Anorganic Bone Mineral Products, K043034 Description of the Device OssiMendTM Bone Graft Material (OssiMend) is a collagen mineral composite matrix processed into str… | 2005 |
What descends from it? (40)
See all 402 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 10 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K082166 (Medtronic Sofamor Danek, 2009) has gone furthest, with 38 descendants of its own.
- 10 other devices also cite its predicate K012751.
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?
OssiMend, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., extiemities, 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 resulting from traumatic injury to the bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052812: Ossimend (TM) Bone Graft Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052812
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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