# K081001: PD Synth, Absorbable (Poly Dioxanone) Suture

- Pathway: 510(k) (Traditional)
- Applicant: Sutures India Pvt., Ltd.
- Decided: Jun 9, 2008 after 62 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 K042285 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042285: Unicryl M, United Medical Industries Co., Ltd. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- P018331: PDS II Absorbable Monofilament 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
- K161737: RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed (2017), 0 descendants of its own

## Indications for use
PD SYNTH IS SYNTHETIC ABSORBABLE (MONOFILAMENT POLYDIOXANONE) SURGICAL SUTURE, STERILE AND FLEXIBLE STRAND, PREPARED FROM THE POLYMER, POLYDIOXANONE, (HOMO POLYMER OF DI OXANONE 100%) AND IS INDICATED FOR USE IN SOFT TISSUE APPROXIMATION, INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIO VASCULAR AND NEUROLOGICAL TISSUES

Source page: https://510kreport.com/device/K081001
Methodology: https://510kreport.com/methodology