# K080918: Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of Size #2-0

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek
- Decided: Apr 23, 2008 after 22 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990088 (1999). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040004: Orthocord Suture, Depuy Mitek (2004)
- K043298: Blue Orthocord Suture, Depuy Mitek (2004) Summary page 1.
- K071622: Arthrex Fiberwire, Arthrex, Inc. (2007) Summary page 1.
- K021434: Arthrex Fiberwire in Usp Sizes, Arthrex, Inc. (2002) Summary page 1.

## Indications for use
Orthocord #2-0 suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.

Source page: https://510kreport.com/device/K080918
Methodology: https://510kreport.com/methodology