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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, toe, hemi-, phalangeal
Regulation Description Toe joint phalangeal (hemi-toe) polymer prosthesis.
Product CodeKWD
Regulation Number 888.3730
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUFIX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPOLY, LLC
  SUBSTANTIALLY EQUIVALENT 2
MONTROSS EXTREMITY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D, INC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX IN TENNESSEE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 19 20
2020 4 4
2021 2 2
2022 10 11
2023 27 27
2024 133 133
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 129 129
Unintended Movement 31 31
Break 8 8
Improper or Incorrect Procedure or Method 6 6
Off-Label Use 4 4
Insufficient Information 4 4
Loosening of Implant Not Related to Bone-Ingrowth 3 3
No Apparent Adverse Event 3 3
Defective Device 2 3
Difficult to Insert 2 2
Use of Device Problem 2 2
Loose or Intermittent Connection 2 2
Loss of Osseointegration 2 2
Malposition of Device 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1
Degraded 1 1
Material Fragmentation 1 1
Failure to Osseointegrate 1 2
Material Deformation 1 1
Detachment of Device or Device Component 1 1
Migration 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 64 64
Implant Pain 46 46
Pain 26 27
Failure of Implant 25 26
Loss of Range of Motion 13 13
Inadequate Pain Relief 8 8
Unspecified Infection 6 6
No Known Impact Or Consequence To Patient 4 4
Swelling 4 5
Osteolysis 4 4
Deformity/ Disfigurement 4 4
No Code Available 3 3
No Clinical Signs, Symptoms or Conditions 3 4
Swelling/ Edema 3 3
Inadequate Osseointegration 2 2
Arthritis 2 2
Abdominal Pain 1 1
Skin Infection 1 1
Complaint, Ill-Defined 1 1
Joint Dislocation 1 1
Wound Dehiscence 1 1
Metal Related Pathology 1 1
Adhesion(s) 1 1
Bone Fracture(s) 1 1
Reaction to Medicinal Component of Device 1 1
Fever 1 1
Foreign Body In Patient 1 1
Erythema 1 1
Skin Inflammation 1 1
Joint Swelling 1 1
Scar Tissue 1 1
Subluxation 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioPro, Inc. II Feb-28-2022
2 Wright Medical Technology, Inc. II Nov-25-2019
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