# K210871: PDO Max Suture with Dual Needle

- Pathway: 510(k) (Traditional)
- Applicant: Pdo Max, Inc.
- Decided: Dec 17, 2021 after 268 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: 10 generations back to K014153 (2002). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120827: Quill Pdo Knotless Tissue-Closure Device (Polydixanone), Angiotech (2012) Summary page 4.

## Indications for use
The PDO Max Suture with Dual Needle is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

Source page: https://510kreport.com/device/K210871
Methodology: https://510kreport.com/methodology