# K980679: Endobon

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 3, 1998 after 42 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K102872: Osbone Dental (2011), 1 descendant of its own
- K202675: InRoad® Dental Synthetic Bone Graft (2022), 0 descendants of its own
- K090793: Bongros HA (2009), 0 descendants of its own

## Recalls of this device
- Oct 3, 2013 · Class III · Z-1233-2014: Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.

## Indications for use
Endobon is used in the following dental and/or oral surgical procedures: - alveolar ridge augmentation/reconstruction - filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall - filling of periodontal bone pockets in the jaw (granules I) - filling bone defects after apicetomy - filling alveoli after after tooth axtraction This product should not be used in non-periodontal mandibular applications.

Source page: https://510kreport.com/device/K980679
Methodology: https://510kreport.com/methodology