STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device— 510(k) K252743

Clearance details

Applicant

ETHICON, Inc.

Product code

Code GAM

Device class

Class 2

Regulation

21 CFR 878.4493

Advisory panel

General, Plastic Surgery

Date received

2025-08-28

Decision date

2025-12-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Raritan, NJ, US

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• K253530 — Trexon Monofilament Synthetic Absorbable Suture2026-05-28
• K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture2026-02-06
• K253620 — TroClose 12002025-12-16
• K252820 — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso) +1 more2025-10-03

• K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices2026-05-18
• K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device2026-03-27
• K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture2025-11-12
• K221744 — STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device2022-11-15
• K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture2022-02-22

Death

45

Injury

5,711

Malfunction

30,744

Other

4

Total

36,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →