Grappler Suture Anchor System
FDA 510(k) K262047 · Paragon 28, Inc.
510(k) numberK262047
Submission
- Device name
- Grappler Suture Anchor System
- Applicant
- Paragon 28, Inc.
Englewood, CO, US - Received
- June 18, 2026
- Decision date
- August 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
| 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 |
| K261363 | Y-Knotless Flex AnchorsMBI · Special | CONMED Corporation | 05/13/2026SE |
More from CONMED Corporation
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|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | 08/28/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | 08/06/2026SE |
| K253886 | Grappler Suture Anchor PCFD Tether SystemMBI · Traditional | 03/17/2026SE |
| K253591 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Traditional | 03/05/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | 12/19/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | 08/11/2025SE |
| K250952 | Baby Gorilla®/Gorilla® Plating SystemHRS · Traditional | 07/18/2025SE |
| K251850 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Special | 07/14/2025SE |
| K250641 | APEX 3D Total Ankle Replacement SystemHSN · Traditional | 05/01/2025SE |
Questions and answers
When was Grappler Suture Anchor System cleared by the FDA?
Grappler Suture Anchor System (K262047) received a 510(k) decision of Substantially Equivalent on August 3, 2026, 46 days after the submission was received.
What is the product code of K262047?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.