Meniscus Versaflex
FDA 510(k) K254188 · GM Dos Reis Industria e Comercio Ltda.
510(k) numberK254188
Submission
- Device name
- Meniscus Versaflex
- Applicant
- GM Dos Reis Industria e Comercio Ltda.
Campinas, BR - Received
- December 23, 2025
- Decision date
- February 19, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
| K241376 | HyperSuture All Blue Extension LineGAT · Traditional | Threadstone, LLC | 08/09/2024SE |
More from Threadstone, LLC
| 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 |
| K252664 | GMReis Suture AnchorsMBI · Traditional | 11/04/2025SE |
| 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 Meniscus Versaflex cleared by the FDA?
Meniscus Versaflex (K254188) received a 510(k) decision of Substantially Equivalent on February 19, 2026, 58 days after the submission was received.
What is the product code of K254188?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.