Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, ankle, uncemented, non-constrained
Definition An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.
Product CodeNTG
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
7 4 2 2 0 0

MDR Year MDR Reports MDR Events
2021 89 89
2022 50 52
2023 12 12
2024 21 21
2025 14 14
2026 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 155 156
Fracture 21 21
Unstable 11 11
Loss of Osseointegration 10 10
Naturally Worn 8 8
Patient Device Interaction Problem 7 7
Inadequacy of Device Shape and/or Size 7 7
Device Dislodged or Dislocated 5 5
Break 5 5
Migration 3 3
Insufficient Device Problem Information 2 2
Material Integrity Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Deformation Due to Compressive Stress 1 1
Noise, Audible 1 1
Material Deformation 1 1
Detachment of Device or Device Component 1 1
Material Fragmentation 1 1
Crack 1 1
Wrong Label 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 71 72
Failure of Implant 57 58
Implant Pain 33 33
Unspecified Infection 31 32
Joint Laxity 23 23
Pain 20 21
Cyst(s) 10 10
Ambulation or Postural Difficulties 7 7
No Clinical Signs, Symptoms or Conditions 7 7
Loss of Range of Motion 6 6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Swelling/ Edema 4 4
Impaired Healing 3 3
Discomfort 2 2
Deformity/ Disfigurement 2 2
Inadequate Pain Relief 2 2
Extraskeletal ossification 2 2
Medical device site infection 2 2
Inadequate Osseointegration 2 2
Rash 1 1
Foreign Body In Patient 1 1
Neuralgia 1 1
Muscle Weakness/Atrophy 1 1
Depression 1 1
Arthritis 1 1
Necrosis 1 1
Anxiety 1 1
Wound Dehiscence 1 1
Arthralgia 1 1
Nonunion/Delayed-union Bone Fracture 1 1
Ankylosis 1 1
Multiple Fractures 1 1
Unspecified Tissue Injury 1 1
Damage to Ligament(s) 1 1
Subluxation 1 1
Abscess 1 1
Malunion of Bone 1 1
Synovitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DT MedTech, LLC II Jun-10-2026
2 Exactech, Inc. II Jan-18-2024
-
-