# K983685: Bone Band

- Pathway: 510(k) (Traditional)
- Applicant: Chapel and Assoc.
- Decided: Dec 4, 1998 after 45 days
- Product code: LYT (Fixation Accessory)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- 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) Parham Band: named in the summary without a submission number

## Indications for use
This bone band is indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates.

Source page: https://510kreport.com/device/K983685
Methodology: https://510kreport.com/methodology