(48 days)
Orthodek™ Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and /or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissue. Orthodek suture is particularly useful where extended wound support (up to 6 months) is desirable.
Orthodek Poly (L-lactide) Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Orthodek is available in size 2 (metric size 5) undyed (white). The suture is a sterile, braided multifilament, is provided in a variety of lengths, with or without needles, and may be supplied in a variety of cut lengths or on ligating reels.
This document describes a 510(k) premarket notification for a surgical suture, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device is not applicable to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Ethicon Panacryl Absorbable Surgical Suture K974299) based on:
- Intended use: General soft tissue approximation and/or ligation, and orthopedic uses.
- Materials: Poly(L-lactide).
- Design: Braided multifilament, size 2 (metric size 5), undyed (white).
- Performance characteristics: Meets all USP requirements except for oversized diameter, with extended wound support up to 6 months.
The review process involved conformance with voluntary performance standards and guidance documents for surgical sutures.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.