# K983885: Burr Hole Covers, Craniomaxillofacial Plates

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Jan 29, 1999 after 88 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
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) Wurzburg Titanium Mini Bone Plating System: named in the summary without a submission number
- (no number) Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates: named in the summary without a submission number
- (no number) Titanium Rigid Fixation & Bone Grafting — TiMesh Inc.: named in the summary without a submission number
- (no number) Luhr® Pan Fixation System: named in the summary without a submission number

## Most influential descendants
- K160739: Cranial COVER (2016), 1 descendant of its own
- K192310: Flap Fixator, Burr Hole Cover (2020), 0 descendants of its own

## Indications for use
The Covers are intended for use in patients requiring craniofacial reconstruction to cover burr holes of various diameters in the craniofacial skeleton in order to provide good cosmetic results and protection of the underlying soft tissues and brain. This device can also be used to secure cranial bone flaps. The Plates are intended for use in patients requiring craniofacial fixation of small bones, craniofacial skeleton, midface bones and hand. These plates provide structure and support following elective osteotomies and internal fixation of fractures of the hand. The Plates are intended for use in patients requiring reconstruction of the cranial area, including the sub-temporal regions. These plates provids fixation and stabilization of cranial bone flaps.

Source page: https://510kreport.com/device/K983885
Methodology: https://510kreport.com/methodology