510(k) · Cleared
ClearedBonemedik-DM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Biomed Co., Ltd. · LYC Bone Grafting Material, Synthetic
Cleared on Jun 3, 2008 as substantially equivalent to K060732 (Biomatlante, 2006) and 2 other predicates after a 76-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Jun 3, 2008
- Review
- 76 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K990131 (1999). 16 ancestors in all, the oldest K871773 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 5 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK032268 MBCPBiomatlante · 2003
- 3 generations backK043005 Modification to MBCPBiomatlante · 2005
- 2 generations backK051885 MBCPBiomatlante · 2005
- 1 generation backK060732 MBCP GelBiomatlante · 2006
- This deviceK080772 Bonemedik-DMMeta Biomed Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −5 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K032268 | MBCP | Biomatlante | 2003 | — |
| −3 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −2 | K051885 | MBCP | Biomatlante | 2005 | — |
| −1 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| 0 (this device) | K080772 | Bonemedik-DM | Meta Biomed Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K060732 | MBCP GelSummary page 2…K072397. 2. OsteoGraf/N-300, cleared by Dentsply, Intl., in K071817, 3. Odoncer, cleared by Teknimed SA in K062102, 4. MBCP Gel, cleared by Biomatlante in K060732, 5. MBCP, cleared by Biomatlante in K051885, 6. OssaPlast Dental, cleared by Ossacur AG in K053374, 7. OsteoGuide Anorga… | 2006 |
| * | K051885 | MBCPSummary page 2…y Dentsply, Intl., in K071817, 3. Odoncer, cleared by Teknimed SA in K062102, 4. MBCP Gel, cleared by Biomatlante in K060732, 5. MBCP, cleared by Biomatlante in K051885, 6. OssaPlast Dental, cleared by Ossacur AG in K053374, 7. OsteoGuide Anorganic Bone ....cleared by Collagen Matrix in K043… | 2005 |
| * | K043034 | Osteoguide Anorganic Bone Mineral ProductsSummary page 2…5. MBCP, cleared by Biomatlante in K051885, 6. OssaPlast Dental, cleared by Ossacur AG in K053374, 7. OsteoGuide Anorganic Bone ....cleared by Collagen Matrix in K043034, 8. OsteoGraf/LD-300 Hydroxyapatite, cleared by Ceramed Corp in K960353. Several of the above cleared bone growth materials… | 2005 |
| † | K070897 | Bonemedik, and Bonemedik-S | 2007 |
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 9 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 2 other devices also cite its predicate K060732.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
BoneMedik-DM is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects, in particular in periodontal or oral/maxillofacial application. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product may be used in surgical procedures such as: Augmentation or reconstructive treatment of the alveolar ridge Filling of periodontal defects Filling of…
Read the full statement (111 words)
BoneMedik-DM is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects, in particular in periodontal or oral/maxillofacial application. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product may be used in surgical procedures such as:
Augmentation or reconstructive treatment of the alveolar ridge
Filling of periodontal defects
Filling of defects after root resection, apicocectomy and cystectomy
Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue regeneration (GTR) and Guided Bone Regeneration (GBR)
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080772 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080772: Bonemedik-DM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080772
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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