# K252644: PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

- Pathway: 510(k) (Special)
- Applicant: M/s. Meril Endo Surgery Private Limited.
- Decided: Sep 23, 2025 after 33 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: 16 generations back to K014153 (2002). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232246: 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture, M/s. Meril Endo Surgery Private Limited. (2024) Summary page 4.

## Indications for use
PINION™ PGA-PCL Knotless Sutures are indicated for use in soft tissue approximation where use of an absorbable suture is appropriate. PINION™ PDO Knotless Suture is indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K252644
Methodology: https://510kreport.com/methodology