# K031714: Inion Trinion Biodegradable Meniscus Screw

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Aug 16, 2004 after 441 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
Longest line of descent: 2 generations back to K925573 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980681: Innovasive Devices Meniscal Screw, Innovasive Devices, Inc. (1998) Summary page 1.
- K002020: Lactosorb Meniscal Screw, Biomet Manufacturing, Inc. (2000) Summary page 1.
- K991715: Biostinger-V Bioabsorbable Meniscal Repair Device, Linvatec Corp. (1999) Summary page 1.
- K955768: Biofix Biodegradable Meniscus Arrow System, Bioscience, Inc. (1996) Summary page 1.

## Indications for use
The Inion Trinion™ Biodegradable Meniscus Screw is indicated for use in the fixation of longitudinal vertical meniscus lesions (bucket handle) located in the vascularized area of the meniscus (red-red and red-white areas).

Source page: https://510kreport.com/device/K031714
Methodology: https://510kreport.com/methodology