Cleared Special

K252644 - PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture (FDA 510(k) Clearance)

Also includes:
PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252644 · M/s. Meril Endo Surgery Private Limited. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
33d
Days
Class 2
Risk

K252644 is an FDA 510(k) clearance for the PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by M/s. Meril Endo Surgery Private Limited. (Vapi, IN). The FDA issued a Cleared decision on September 23, 2025 after a review of 33 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all M/s. Meril Endo Surgery Private Limited. devices

Submission Details

510(k) Number K252644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2025
Decision Date September 23, 2025
Days to Decision 33 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 114d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEW Suture, Surgical, Absorbable, Polydioxanone

All 61
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K252644.
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
K243897 · Ethicon, Inc. · Nov 2025
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
K251414 · Feeltech Co., Ltd. · Oct 2025
V-soft Line™ Barbed Surgical Suture (Various)
K250107 · Feeltech Co., Ltd. · Oct 2025
Suture-TOOL System
K250977 · Suturion AB · Apr 2025
Suture-TOOL System
K242835 · Suturion AB · Jan 2025
Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938
K242571 · Hyundae Meditech Co., Ltd. · Sep 2024