Stitch Cerclage Suture Tapes
FDA 510(k) K243905 · GM Dos Reis Industria e Comercio Ltda.
510(k) numberK243905
Submission
- Device name
- Stitch Cerclage Suture Tapes
- Applicant
- GM Dos Reis Industria e Comercio Ltda.
Campinas, BR - Received
- December 19, 2024
- Decision date
- August 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. | 07/16/2026SE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…JDQ · Traditional | Arthrex, Inc. | 02/20/2025SE |
| K232733 | Mbrace CableJDQ · Traditional | Medacta International S.A. | 05/03/2024SE |
| K233949 | ACCORD Cable SystemJDQ · Traditional | Smith & Nephew, Inc. | 03/13/2024SE |
| K232986 | VariTrax Sternal CircumFixation SystemJDQ · Traditional | Circumfix Solutions, Inc. | 01/30/2024SE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage suturesJDQ · Traditional | Arthrex, Inc. | 08/24/2023SE |
| K231333 | STRETTO Cable SystemJDQ · Traditional | Globus Medical, Inc. | 08/04/2023SE |
| K220765 | HS Fiber CerclageJDQ · Traditional | Riverpoint Medical, LLC | 07/26/2023SE |
| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 10/19/2022SE |
| K211613 | Stern Fix Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 01/19/2022SE |
More from Neos Surgery S.L
| 510(k) | Device | Decision |
|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | 08/22/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | 08/19/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | 07/21/2026SE |
| K260390 | Super Upper Limbs Versalock Plating SystemHRS · Traditional | 03/17/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | 02/19/2026SE |
| K252664 | GMReis Suture AnchorsMBI · Traditional | 11/04/2025SE |
| K243740 | Versalock Upper Limb Plating SystemHRS · Traditional | 01/29/2025SE |
| K242998 | GMReis Ankle Plating SystemHRS · Traditional | 11/21/2024SE |
| K242596 | Versalock Mini and Micro Plating SystemHRS · Traditional | 11/21/2024SE |
| K242311 | EXPERT - Flexible Joint Fixation SystemHTN · Traditional | 11/01/2024SE |
Questions and answers
When was Stitch Cerclage Suture Tapes cleared by the FDA?
Stitch Cerclage Suture Tapes (K243905) received a 510(k) decision of Substantially Equivalent on August 14, 2025, 238 days after the submission was received.
What is the product code of K243905?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.