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Wedgeloc 180X (Standard and Cortical) Suture Anchor With Opti-Fiber Sutures

by Medshape Solutions

510(k) K092914

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK092914 Date9 Dec 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Wedgeloc 180X (Standard and Cortical) Suture Anchor With Opti-Fiber Sutures is a bone anchor designed for securing sutures to cortical and cancellous bone. It is classified as a suture anchor and is intended for orthopedic applications, providing stable fixation in procedures such as rotator cuff repairs, tendon reattachments, or ligament reconstructions in the shoulder, foot, ankle, or knee.

This device is supplied as a sterile, single-use orthopedic implant and is regulated under FDA 510(k) clearance (K092914) as a substantially equivalent orthopedic fixation product. It is available in varying diameters and is intended for use in surgical settings where secure suture fixation to bone is required. Storage and handling must comply with sterile medical device protocols to ensure integrity before use.

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