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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device scaffold, partial medial meniscal defects extending into the red/white zone, resorbable bovine collagen
Definition Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patients own soft tissue. The device is not a prosthetic device and is not intended to replace normal body structure.
Product CodeOLC
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
IVY SPORTS MEDICINE, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Insufficient Information 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Corporation II Mar-12-2018
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