TeKBrace Knotless Anchor— 510(k) K253538

Substantially Equivalent

Theramicro

FDA 510(k) clearance K253538 for TeKBrace Knotless Anchor, Substantially Equivalent on 2026-03-06. Applicant: Theramicro.

Clearance details

Applicant: Theramicro
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2025-11-13
Decision date: 2026-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordova, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.