# K080772: Bonemedik-DM

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Jun 3, 2008 after 76 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990131 (1999). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060732: MBCP Gel, Biomatlante (2006) Summary page 2.
- K051885: MBCP, Biomatlante (2005) Summary page 2.
- K043034: Osteoguide Anorganic Bone Mineral Products, Collagen Matrix, Inc. (2005) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K080772
Methodology: https://510kreport.com/methodology