# K182881: Bone Screw, Bone Tack

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Aug 9, 2019 after 298 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- 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 K894844 (1990). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011698: Straumann GBR System, Institut Straumann AG (2001) Summary page 4.
- K050669: Jeil Bone Fixation System, Jeil Medical Corporation (2005) Summary page 4.
- K080074: Ace Surigical Tru-Fix Implant System, Model 454-180X-XX, Ace Surgical Supply Co., Inc. (2008) Summary page 4.

## Most influential descendants
- K251569: Bone Screw (2025), 0 descendants of its own

## Indications for use
Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. Bone Tack is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

Source page: https://510kreport.com/device/K182881
Methodology: https://510kreport.com/methodology