• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer
Regulation Description Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
Definition Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.
Product CodeNJD
Regulation Number 888.3535
Device Class 2


Premarket Reviews
ManufacturerDecision
ENGAGE UNI, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 2 2
Installation-Related Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Bone Fracture(s) 1 1

-
-