Device
The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical k...
Manufacturer
MERIL ENDO SURGERY PRIVATE LIMITED
MERIL ENDO SURGERY PRIVATE LIMITED
Model: PNDS010201XLH
DI: 08904255256637
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is (C4H6O3)x. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 5-0 (1), 4-0 (1.5), 3-0 (2), 2-0 (3), 0 (3.5), 1 (4) & 2(5) . It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption. The PINION™ PDO Knotless Suture is designed with small unidirectional and idirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors,equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. The USP designations for diameter are applicable to the PINION™ PDO Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PDO Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PDO Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
47f85dcb-c15d-4f4a-96ed-ae2793b3dcf1
Distribution Status:
In Commercial Distribution
DUNS Number:
870914838
Device Count:
12
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
18904255256634
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08904255256637
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 60480
Name: Barbed polyester suture, non-antimicrobial
Definition:
A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. It does not include antimicrobial agents/materials. This is a single-use device.
FDA Product Codes
NEW
Suture, Surgical, Absorbable, Polydioxanone
Premarket Submissions
Submission Number:
K252644
Supplement Number:
000