DeviceClearance

Grappler Suture Anchor PCFD Tether System— 510(k) K253886

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K253886 for Grappler Suture Anchor PCFD Tether System, Substantially Equivalent on 2026-03-17. Applicant: Paragon 28, Inc.. Device class: 2.

Summary

Paragon 28's Grappler Suture Anchor PCFD Tether System is filed under MBI, nondegradable soft tissue fixation fasteners. The record doesn't list anchor sizes or components.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Paragon 28 filed from Englewood, Colorado. Review took 103 calendar days (December 4, 2025 to March 17, 2026).

Clearance details

Applicant
Paragon 28, Inc.
Product code
Product code MBI
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Englewood, CO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.