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 orthopaedic surgical planning and instrument guides
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
Product CodePBF
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
3D LIFEPRINTS UK , LTD.
  SUBSTANTIALLY EQUIVALENT 1
3D SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
3D SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
3D-SIDE S.A.
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
CENTERMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDCAD
  SUBSTANTIALLY EQUIVALENT 4
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 4
REDPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 12 12
2022 53 53
2023 45 45
2024 34 34
2025 62 62
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 153 153
Use of Device Problem 57 57
Insufficient Device Problem Information 4 4
Patient Device Interaction Problem 2 2
Appropriate Device Problem Term/Code Not Available 2 2
Unstable 1 1
Malposition of Device 1 1
Unintended Movement 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Failure to Align 1 1
Application Program Problem: Parameter Calculation Error 1 1
Inadequacy of Device Shape and/or Size 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Application Program Problem: Power Calculation Error 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Osseointegration 71 71
Unspecified Infection 49 49
Joint Dislocation 42 42
Joint Laxity 19 19
Bacterial Infection 10 10
Pain 8 8
No Clinical Signs, Symptoms or Conditions 8 8
Bone Fracture(s) 7 7
Unequal Limb Length 7 7
Insufficient Information 4 4
Failure of Implant 4 4
Joint Impingement 3 3
Medical device site infection 1 1
Periprosthetic fracture 1 1
Tissue Irritation 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Metal Related Pathology 1 1
Unspecified Musculoskeletal problem 1 1
Skin Inflammation/ Irritation 1 1
Implant Pain 1 1
Hematoma 1 1
Osteolysis 1 1
Loss of Range of Motion 1 1
Arthralgia 1 1

-
-