# K181582: DemeTECH DemeDIOX absorbable surgical suture

- Pathway: 510(k) (Special)
- Applicant: Demetech Corporation
- Decided: Aug 27, 2018 after 73 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: 2 generations back to K013274 (2001). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082097: Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture, Demetech Corp. (2010) Summary page 4.

## Most influential descendants
- K254238: MINT MONO Sutures (2026), 0 descendants of its own
- K251414: Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (2025), 0 descendants of its own

## Indications for use
DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.

Source page: https://510kreport.com/device/K181582
Methodology: https://510kreport.com/methodology