# K012908: Bioplate Resorbable Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Bioplate, Inc.
- Decided: Nov 28, 2001 after 90 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 its predicate without a number.
- (no number) Bioplate® Bone Plating System for Craniomaxillofacial Surgery, Biolactate™: named in the summary without a submission number

## Most influential descendants
- K051845: The Bioplate Resorbable Endobrow Fixation System (2005), 1 descendant of its own
- K061507: Sonicweld RX Endobrow Fixation (2006), 0 descendants of its own

## Indications for use
Bioplate Resorbable Bone Screws are intended for use in conjunction with Codman CRANIOSORB™ plates and meshes in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton in which resorbable fixation is desired. The plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs. The Bioplate Resorbable Bone Screws are intended for minimally load bearing fixation for the following indications: Reconstructive procedures of the craniomaxillofacial skeleton Repair of Craniofacial fractures Cranial bone fixation Brow lift procedures

Source page: https://510kreport.com/device/K012908
Methodology: https://510kreport.com/methodology