# K212380: PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Feb 22, 2022 after 204 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960653 (1996). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061037: PDS Plus Antibacterial Suture, ETHICON, Inc. (2006) Summary page 4.

## Most influential descendants
- K243897: PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture (2025), 0 descendants of its own
- K251414: Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (2025), 0 descendants of its own

## Recalls of this device
- May 10, 2024 · Class II · Z-2147-2024: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

## Indications for use
PDSTM Plus Suture is indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur. PDSTM Plus Suture is not indicated in adult cardiovascular and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

Source page: https://510kreport.com/device/K212380
Methodology: https://510kreport.com/methodology