Grappler Suture Anchor PCFD Tether System
FDA 510(k) K253886 · Paragon 28, Inc.
510(k) numberK253886
Submission
- Device name
- Grappler Suture Anchor PCFD Tether System
- Applicant
- Paragon 28, Inc.
Englewood, CO, US - Received
- December 4, 2025
- Decision date
- March 17, 2026
- 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
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| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | 08/06/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | 08/03/2026SE |
| 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 PCFD Tether System cleared by the FDA?
Grappler Suture Anchor PCFD Tether System (K253886) received a 510(k) decision of Substantially Equivalent on March 17, 2026, 103 days after the submission was received.
What is the product code of K253886?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.