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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
Product CodeJDR
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENT., INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMEDICAL ENTERPRISES, INC
  SUBSTANTIALLY EQUIVALENT 2
BIOMEDICAL ENTERPRISES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 3
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DALLEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
EPIC EXTREMELY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXOTOE LLC
  SUBSTANTIALLY EQUIVALENT 1
F & A FOUNDATION LLC D.B.A. REIGN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FIRST RAY LLC
  SUBSTANTIALLY EQUIVALENT 2
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 3
IN2BONESUSA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSTRATEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISCOPE MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
METASURG
  SUBSTANTIALLY EQUIVALENT 1
METRIC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MX ORTHOPEDICS, CORP.
  SUBSTANTIALLY EQUIVALENT 2
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NOVATSEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHODISCOVERY GROUP LLC(D.B.A. CROSSROADS EXTREMITY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOHELIX SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOVESTMENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28 INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
RESTORE SURGICAL LLC DBA INSTRATEK
  SUBSTANTIALLY EQUIVALENT 1
RMR ORTHO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOLANA SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 2
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 3
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 49 49
2015 48 48
2016 76 76
2017 116 116
2018 239 239
2019 242 242
2020 234 234
2021 210 210
2022 202 209
2023 175 175
2024 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Break 575 575
Adverse Event Without Identified Device or Use Problem 296 300
Detachment of Device or Device Component 133 133
Fracture 100 100
Device Dislodged or Dislocated 42 42
Migration 40 43
Migration or Expulsion of Device 37 37
Material Frayed 37 37
Device-Device Incompatibility 34 34
Appropriate Term/Code Not Available 32 32
Insufficient Information 32 32
Manufacturing, Packaging or Shipping Problem 29 29
Difficult to Advance 24 24
Physical Resistance/Sticking 23 23
Material Split, Cut or Torn 23 23
Device Operates Differently Than Expected 20 20
Crack 19 19
Unknown (for use when the device problem is not known) 18 18
Material Separation 17 17
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Activation, Positioning or Separation Problem 14 14
Positioning Failure 13 13
Patient Device Interaction Problem 13 13
Material Deformation 11 11
Failure to Advance 11 11
Mechanical Jam 9 9
Entrapment of Device 9 9
Improper or Incorrect Procedure or Method 8 8
Material Fragmentation 8 8
Difficult to Insert 8 8
Packaging Problem 8 8
Unintended Movement 8 8
Material Twisted/Bent 7 7
Loose or Intermittent Connection 7 7
Detachment Of Device Component 7 7
Device Slipped 7 7
No Apparent Adverse Event 6 6
Patient-Device Incompatibility 6 6
Device Contaminated During Manufacture or Shipping 6 6
Connection Problem 5 5
Device Damaged by Another Device 5 5
Difficult to Remove 5 5
Separation Failure 5 5
Mechanical Problem 5 5
Component Falling 5 5
Material Integrity Problem 5 5
Difficult or Delayed Positioning 5 5
Failure to Form Staple 4 4
Inaccurate Information 4 4
Difficult To Position 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 470 470
No Consequences Or Impact To Patient 243 243
No Known Impact Or Consequence To Patient 215 215
Pain 116 116
No Code Available 115 115
Non-union Bone Fracture 78 78
Injury 67 67
Failure of Implant 60 60
Tissue Damage 59 59
Insufficient Information 56 56
Not Applicable 56 56
Foreign Body In Patient 50 50
No Information 43 43
Unspecified Infection 36 36
Bone Fracture(s) 30 30
No Patient Involvement 26 26
Post Operative Wound Infection 26 26
Loss of Range of Motion 25 28
Unspecified Tissue Injury 23 23
Impaired Healing 18 18
Perforation 15 15
Discomfort 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Implant Pain 12 16
Hypersensitivity/Allergic reaction 11 11
Device Embedded In Tissue or Plaque 11 11
Reaction 10 10
Wound Dehiscence 8 8
Unknown (for use when the patient's condition is not known) 6 6
Swelling 6 6
Osteolysis 5 5
Patient Problem/Medical Problem 5 5
Foreign Body Reaction 5 5
Fall 4 4
Abscess 4 4
Malunion of Bone 4 4
Rupture 4 4
Cyst(s) 4 4
Hematoma 4 4
Inflammation 4 4
Joint Dislocation 4 4
Erosion 4 4
Bacterial Infection 4 4
Skin Infection 3 3
Swelling/ Edema 3 3
Cellulitis 3 3
Synovitis 3 3
Weakness 3 3
Surgical procedure, delayed 3 3
Arthritis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-18-2022
2 Biomet, Inc. II Apr-02-2015
3 Crossroads Extremity Systems Llc II Mar-20-2017
4 In2bones USA, LLC II Dec-22-2018
5 Integra LifeSciences Corp. III Mar-04-2017
6 Merete Medical GmbH II Feb-17-2022
7 Paragon 28, Inc. II Jun-20-2018
8 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013
9 Stryker GmbH II Nov-16-2020
10 Stryker Howmedica Osteonics Corp. II Feb-23-2016
11 Synthes (USA) Products LLC II Oct-18-2022
12 Synthes (USA) Products LLC II Oct-06-2022
13 TriMed Inc. II Jun-20-2018
14 Wright Medical Technology, Inc. II Mar-31-2022
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