# K080259: Jmea Cannulated Bone Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Jmea Corporation
- Decided: Aug 20, 2008 after 202 days
- Product code: HWC (Screw, Fixation, Bone)
- 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) Arthrex Cannulated Interference Screw (Smith & Nephew Dyonics): named in the summary without a submission number
- (no number) Cannulated Interference Screw System (Linvatec): named in the summary without a submission number
- (no number) Titanium Cannulated Interference Screw (Future Medical Systems): named in the summary without a submission number
- (no number) Acufex Sterile Cannulated Interference Screws (Acufex Microsurgical): named in the summary without a submission number

## Indications for use
The JMEA cannulated bone screws are used to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy.

Source page: https://510kreport.com/device/K080259
Methodology: https://510kreport.com/methodology