DeviceClearance

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. Device class: 2.

Summary

Theramicro's TeKBrace Knotless Anchor is filed under MBI, nondegradable soft tissue fixation fasteners. The record doesn't list anchor sizes.

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).

Theramicro filed from Cordova, Tennessee. Review took 113 calendar days (November 13, 2025 to March 6, 2026).

Clearance details

Applicant
Theramicro
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
Cordova, TN, 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.