Atlas FDA

Trexon™ Monofilament Synthetic Absorbable Suture

FDA 510(k) clearance K253530 · decided 2026-05-28

Clearance details

K-number
K253530
Device name
Trexon™ Monofilament Synthetic Absorbable Suture
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2025-11-13
Decision date
2026-05-28
Days to decision
196 days
Clearance type
Traditional
Product code
GAM
Device class
2
Regulation number
878.4493
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
North Haven, CT, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture (K253394)ETHICON, Inc.2026-06-25
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (K253852)ETHICON, Inc.2026-02-06
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K252743)ETHICON, Inc.2025-12-22
TroClose 1200 (K253620)Gordian Surgical, Ltd.2025-12-16
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) (K252820)Internacional Farmacéutica S.A DE C.V2025-10-03
Monotime and Optime R (K233265)Peters Surgical2024-10-11
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (K232372)Peters Surgical2024-07-12
StitchKit (K221527)Origami Surgical Inc .2023-02-14
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K221744)ETHICON, Inc.2022-11-15
MONOFIX PGCL, knotless wound closure device (K212810)Samyang Holdings Corp., Ltd.2022-08-05
StitchKit (K211792)Origami Surgical Inc .2021-07-16
StitchKit COMBO (K202950)Origami Surgical2021-02-23

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HeartWare HVAD System (P100047/S227)Medtronic2025-07-09
HeartWare­™ Ventricular Assist System (HVAD) (P100047/S230)Medtronic2025-06-26
HeartWare™ Ventricular Assist System (HVAD) (P100047/S229)Medtronic2025-06-05
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228)Medtronic2025-06-04
HeartWare HVAD System (P100047/S226)Medtronic2025-05-05
HeartWare® HVAD System (P100047/S225)Medtronic2025-04-24
HeartWare HVAD System (P100047/S224)Medtronic2025-04-02
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222)Medtronic2025-03-13