Miach Orthopaedics

FDA Regulatory Profile

Miach Orthopaedics appears in FDA public data with 2 recalls, 3 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-1220-2026, Class II) was initiated on December 31, 2025. Its most recent 510(k) clearance was granted on January 13, 2026.

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1220-2026Class IIBEAR Implant. Model Number: 1000.December 31, 2025
Z-0479-2026Class IIBEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;February 2, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K251214BEAR® (Bridge-Enhanced ACL Restoration) ImplantJanuary 13, 2026
K243578BEAR® (Bridge-Enhanced ACL Restoration) ImplantMarch 6, 2025
DEN200035BEAR (Bridge-Enhanced ACL Repair) ImplantDecember 16, 2020