# K992367: Ebi Xfix Dynafix System HA Coated Screws

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Sep 23, 1999 after 70 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Orthofix® External Fixation Screw with Hydroxapatite Coating-Orthofix Srl: named in the summary without a submission number

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0528-2020: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- Apr 1, 2016 · Class II · Z-1823-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non

## Indications for use
The EBI X FIX DynaFix® Hydroxyapatite® (HA) Coated Screws are intended for use in external fixation for the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K992367
Methodology: https://510kreport.com/methodology