# K082097: Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Demetech Corp.
- Decided: Jan 8, 2010 after 533 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: 1 generation back to K013274 (2001). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013274: Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile, Cp Medical (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- P018331: Ethicon PDS II Synthetic Absorbable Monofilament Suture Polydioxanone Suture. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K181582: DemeTECH DemeDIOX absorbable surgical suture (2018), 2 descendants of its own
- K254238: MINT MONO Sutures (2026), 0 descendants of its own
- K251414: Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (2025), 0 descendants of its own
- K191361: DemeDIOX Barbed Absorbable Surgical Suture (2019), 0 descendants of its own

## Indications for use
Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in all types of 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/K082097
Methodology: https://510kreport.com/methodology