# K994060: The Bioplate Resorbable Bone Plating System for Craniomaxillofacial Surgery, Biolactate

- Pathway: 510(k) (Traditional)
- Applicant: Bioplate, Inc.
- Decided: Jan 24, 2001 after 421 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955729 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955729: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 1.
- K974554: Synthes Resorbable Fixation System, Synthes (Usa) (1998) Summary page 1.
- K982531: Howmedica Leibinger Resorbable Fixation System, Howmedica Corp. (1998) Summary page 1.
- K980983: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1998) Summary page 1.

## Indications for use
The Bioplate Resorbable Bone Plating System is intended for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for craniomaxillofacial indications in which resorbable fixation is desired. Plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs. The resorbable plates and screws are intended for minimally load bearing fixation for the following indications: Craniofacial fractures Reconstructive procedures of the craniomaxillofacial skeleton Cranial bone fixation Brow lift procedures

Source page: https://510kreport.com/device/K994060
Methodology: https://510kreport.com/methodology