# K031216: Monoplus Poly-P-Dioxanone Monofilament Absorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap
- Decided: Jul 17, 2003 after 91 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K183331: Parcus GFS BTB, Parcus Medical, LLC (2019). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K160705: Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, (2016), 0 descendants of its own

## Indications for use
MonoPlus Poly-p-dioxanone absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in pediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, micrcisurgery and neural tissue.

Source page: https://510kreport.com/device/K031216
Methodology: https://510kreport.com/methodology