Cleared Traditional

Stitch Cerclage ? Suture Tapes

K243905 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic
Aug 2025
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K243905 is an FDA 510(k) clearance for the Stitch Cerclage ? Suture Tapes, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on August 14, 2025, 238 days after receiving the submission on December 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K243905 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2024
Decision Date August 14, 2025
Days to Decision 238 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDQ — Cerclage, Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3010

Similar Devices — JDQ Cerclage, Fixation

All 128
Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
K243344 · Arthrex, Inc. · Feb 2025
Mbrace Cable
K232733 · Medacta International S.A. · May 2024
ACCORD Cable System
K233949 · Smith & Nephew, Inc. · Mar 2024
VariTrax Sternal CircumFixation System
K232986 · Circumfix Solutions, Inc. · Jan 2024
Arthrex Radiopaque FiberTape Cerclage sutures
K230976 · Arthrex, Inc. · Aug 2023
STRETTO? Cable System
K231333 · Globus Medical, Inc. · Aug 2023