TPLC - Total Product Life Cycle

• Device: bone wedge
• Regulation Description: Single/multiple component metallic bone fixation appliances and accessories.
• Definition: Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
• Product Code: PLF
• Regulation Number: 888.3030
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AMES MEDICAL PROSTHETIC SOLUTIONS, S.A.U.
	SUBSTANTIALLY EQUIVALENT	1
AUXANO MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
NVISION BIOMEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
NVISION BIOMEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	2
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
PARAGON 28 INC
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
SINAPTIC SURGICAL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	3	3
2021	2	2
2022	4	4
2023	4	4
2024	3	3
2025	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9	9
Break	5	5
Entrapment of Device	1	1
Malposition of Device	1	1
Material Disintegration	1	1
Insufficient Information	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	5	5
No Clinical Signs, Symptoms or Conditions	3	3
Pain	3	3
Unspecified Infection	2	2
Failure of Implant	1	1
Implant Pain	1	1
Foreign Body In Patient	1	1
Swelling	1	1
Arthritis	1	1
Device Embedded In Tissue or Plaque	1	1