510(k) · Cleared
ClearedBonemedik, and Bonemedik-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Biomed Co., Ltd. · MQV Filler, Bone Void, Calcium Compound
Cleared on Sep 17, 2007 as substantially equivalent to P860005 (Interpore Intl., 1992) and 4 other predicates after a 168-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Sep 17, 2007
- Review
- 168 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K960978 (1996). 21 ancestors in all, the oldest P860005 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 5 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
- 4 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
- 3 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
- 2 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
- 1 generation backK060917 Kensey Nash Bone Void FillerKensey Nash Corporation · 2006
- This deviceK070897 Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −6 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −5 | K000515 | Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101… | Interpore Cross Intl. | 2000 | — |
| −4 | K012751 | Healos Bone Graft Material | Orquest, Inc. | 2001 | — |
| −3 | K043308 | Modification to: Healos Bone Graft Material | Depuy Spine, Inc. | 2005 | — |
| −2 | K051386 | Mastergraft Putty Bone Void Filler | Medtronic Vascular | 2005 | — |
| −1 | K060917 | Kensey Nash Bone Void Filler | Kensey Nash Corporation | 2006 | — |
| 0 (this device) | K070897 | Bonemedik, and Bonemedik-S | Meta Biomed Co., Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | P860005 | Pro Osteon Implant 500 Hydroxyapatite Bone Void FillerSummary page 2…bstantially equivalent (and nearly identical) to the Interpore, Intl. product, "Pro Osteon Implant 500 products originally cleared under the Premarket Approval system as P860005 and after reclassification cleared under 510(k)s K990131, K980817 and others. Like Pro Osteon 500, BoneMedik and BoneMedik-S are… | 1992 |
| * | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft SubstituteSummary page 2…rpore, Intl. product, "Pro Osteon Implant 500 products originally cleared under the Premarket Approval system as P860005 and after reclassification cleared under 510(k)s K990131, K980817 and others. Like Pro Osteon 500, BoneMedik and BoneMedik-S are based on natural product that provides the unique structu… | 1999 |
| * | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…Summary page 2…tl. product, "Pro Osteon Implant 500 products originally cleared under the Premarket Approval system as P860005 and after reclassification cleared under 510(k)s K990131, K980817 and others. Like Pro Osteon 500, BoneMedik and BoneMedik-S are based on natural product that provides the unique structure. BoneM… | 1998 |
| * | K060917 | Kensey Nash Bone Void FillerSummary page 2…that provides the unique structure. BoneMedik and BoneMedik-S are also substantially equivalent to the Kensey- Nash Bone Void Filler, cleared by the Kensey Nash Corp. in K060917 and K033679, and several others. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memo… | 2006 |
| * | K033679 | Copsios Bone Void Filler (BVF)Summary page 2…s the unique structure. BoneMedik and BoneMedik-S are also substantially equivalent to the Kensey- Nash Bone Void Filler, cleared by the Kensey Nash Corp. in K060917 and K033679, and several others. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3… | 2004 |
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 8 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 21 ancestors have a recall of any class.
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. 2007, 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?
BoneMedik and BoneMedik-S are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide 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/K070897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070897: Bonemedik, and Bonemedik-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070897
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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