# 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

- Pathway: 510(k) (Traditional)
- Applicant: M/s. Meril Endo Surgery Private Limited.
- Decided: Apr 25, 2024 after 272 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: 15 generations back to K014153 (2002). 47 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182873: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices, ETHICON, Inc. (2019) Summary page 6.
- K151200: STRATAFIX  Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device, ETHICON, Inc. (2015) Summary page 6.
- K221744: STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device, ETHICON, Inc. (2022) Summary page 6.

## Most influential descendants
- K252644: PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture (2025), 0 descendants of its own

## Indications for use
1. PINIONTM PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate. 2. PINIONT M PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K232246
Methodology: https://510kreport.com/methodology