DeviceClearance

Suture Button Repair System— 510(k) K261770

Substantially Equivalent

Skeletal Dynamics, Inc.

FDA 510(k) clearance K261770 for Suture Button Repair System, Substantially Equivalent on 2026-07-29. Applicant: Skeletal Dynamics, Inc.. Device class: 2.

Summary

Skeletal Dynamics' Suture Button Repair System is filed under MBI, nondegradable soft tissue fixation fasteners. The record doesn't list the system's components or materials.

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).

Skeletal Dynamics filed from Miami, Florida. Review took 61 calendar days (May 29 to July 29, 2026).

Clearance details

Applicant
Skeletal Dynamics, 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
Miami, FL, 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.