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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device resorbable implant for anterior cruciate ligament (acl) repair
Regulation Description Resorbable implant for anterior cruciate ligament (ACL) repair.
Definition A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
Product CodeQNI
Regulation Number 888.3044
Device Class 2


Premarket Reviews
ManufacturerDecision
MIACH ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2024 2 2
2025 29 29
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 25 25
Adverse Event Without Identified Device or Use Problem 5 5
Use of Device Problem 2 2
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 24 24
Post Traumatic Wound Infection 2 2
Arthritis 2 2
Blister 1 1
Loss of Range of Motion 1 1
Pain 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Miach Orthopaedics II Jan-29-2026
2 Miach Orthopaedics II Nov-07-2025
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