GMReis Suture Anchors
FDA 510(k) K252664 · GM Dos Reis Industria e Comercio Ltda.
510(k) numberK252664
Submission
- Device name
- GMReis Suture Anchors
- Applicant
- GM Dos Reis Industria e Comercio Ltda.
Campinas, BR - Received
- August 22, 2025
- Decision date
- November 4, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262809 | ArthroTAK Tendon Anchor KitMBI · Special | ArthroTAK, LLC | 09/02/2026SE |
| K253065 | Aevumed SUPERCYNCH Button SystemMBI · Traditional | Aevumed, Inc. | 09/02/2026SE |
| K262677 | Iconix Knotless TMBI · Special | Riverpoint Medical | 08/27/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | Paragon 28, Inc. | 08/03/2026SE |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | Stryker Endoscopy | 07/30/2026SE |
| K261770 | Suture Button Repair SystemMBI · Traditional | Skeletal Dynamics, Inc. | 07/29/2026SE |
| K261632 | Thunderbolt SystemMBI · Special | Responsive Arthroscopy, Inc. | 07/20/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | Smith & Nephew, Inc. | 07/09/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | Arthrex, Inc. | 06/26/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
More from ZheJiang Decans Medical Devices Co., Ltd.
| 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 |
| K243905 | Stitch Cerclage Suture TapesJDQ · Traditional | 08/14/2025SE |
| 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 GMReis Suture Anchors cleared by the FDA?
GMReis Suture Anchors (K252664) received a 510(k) decision of Substantially Equivalent on November 4, 2025, 74 days after the submission was received.
What is the product code of K252664?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.