# K982751: Implex Screw and Washer System

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Feb 1, 1999 after 179 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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) Implex Continuum® Bone Screw: named in the summary without a submission number
- (no number) MDLI Soft Tissue Screw and Washer System: named in the summary without a submission number
- (no number) Mitek Screw and Washer System: named in the summary without a submission number

## Indications for use
The Implex Screw and Washer System is indicated for use in the attachment of ligaments, tendons and other soft tissue to bone.

Source page: https://510kreport.com/device/K982751
Methodology: https://510kreport.com/methodology