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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device staple, fixation, bone
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeJDR
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENT., INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMEDICAL ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 2
BIOMEDICAL ENTERPRISES, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENTERPRISES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
CROSSROADS EXTREMITY SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 2
DALLEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
FIRST RAY LLC
  SUBSTANTIALLY EQUIVALENT 2
FUSION ORTHOPEDICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 3
INSTRATEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVATSEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOHELIX SURGICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 1
OT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 163
Adverse Event Without Identified Device or Use Problem 30
Material Frayed 28
Detachment of Device or device Component 24
Migration or Expulsion of Device 22
Insufficient Information 21
Fracture 19
Material Split, Cut or Torn 14
Device Operates Differently Than Expected 10
Positioning Failure 10
Failure to Advance 9
Appropriate Term/Code Not Available 9
Activation, Positioning or Separation Problem 9
Migration 7
Difficult to Insert 6
Mechanical Jam 5
Separation Failure 4
Material Rupture 4
Difficult To Position 4
Improper or Incorrect Procedure or Method 4
Difficult or Delayed Positioning 4
Staple 3
Bent 3
Device Damaged by Another Device 3
Device Contaminated during manufacture or shipping 3
Unintended Movement 3
Inadequacy of Device Shape and/or Size 2
Device-Device Incompatibility 2
Packaging Problem 2
Difficult to Advance 2
Manufacturing, Packaging or Shipping Problem 2
Delivered as Unsterile Product 2
No Apparent Adverse Event 2
Activation Problem 1
Device Dislodged or Dislocated 1
Disassembly 1
Unintended Ejection 1
Use of Device Problem 1
Contamination / decontamination Problem 1
Connection Problem 1
Device Difficult to Maintain 1
Material Disintegration 1
Device Operational Issue 1
Material Twisted / Bent 1
Device Component Or Accessory 1
Suture 1
Failure To Adhere Or Bond 1
Material Integrity Problem 1
Moisture or Humidity Problem 1
Malposition of device 1
Needle 1
Crack 1
Mechanical Problem 1
Device Contamination with Chemical or Other Material 1
Material Deformation 1
Detachment Of Device Component 1
Off-Label Use 1
Device Issue 1
Patient Device Interaction Problem 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Total Device Problems 462

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-02-2015
2 Crossroads Extremity Systems Llc II Mar-20-2017
3 In2bones USA, LLC II Dec-22-2018
4 Integra LifeSciences Corp. III Mar-04-2017
5 Paragon 28, Inc. II Jun-20-2018
6 Stryker Howmedica Osteonics Corp. II Feb-23-2016
7 TriMed Inc. II Jun-20-2018

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