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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 8
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ADDITIVE ORTHOPAEDICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 8
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENTERPRISES, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 4
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CONVENTUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 8
ENDEAVOR ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC EXTREMITY, LLC
  SUBSTANTIALLY EQUIVALENT 3
EXSOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 3
FIELD ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GENESIS FRACTURE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 5
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERICO LTDA.
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GREENS SURGICALS PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 2
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 11
IN2BONESUSA, LLC
  SUBSTANTIALLY EQUIVALENT 2
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JACE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 15
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JM LONGYEAR MANUFACTURING, LLC D.B.A. ABLE MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
JM LONGYEAR MANUFACTURING, LLC D/B/A ABLE MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN LP
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
LEITH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 2
MAXXION MEDICAL, LLC / BAUMER SA
  SUBSTANTIALLY EQUIVALENT 1
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 10
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE, INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIAMI DEVICE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 5
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
MX ORTHOPEDICS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
NARANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEBULA SURGICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 11
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
ORTHO SOLUTIONS UK LTD
  SUBSTANTIALLY EQUIVALENT 2
ORTHOCARE
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 2
PANTHEON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 2
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIG MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIG MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 12
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 11
STUCKENBROCK MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
TRIDENT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL, LTD
  SUBSTANTIALLY EQUIVALENT 2
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 2
TRUEMED GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 8
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2275 2275
2017 2216 2216
2018 2662 2662
2019 3356 3356
2020 2791 2791
2021 2431 2431

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6292 6292
Break 3196 3196
Fracture 1120 1120
Device-Device Incompatibility 469 469
Insufficient Information 424 424
Migration or Expulsion of Device 412 412
Migration 376 376
Appropriate Term/Code Not Available 365 365
Device Operates Differently Than Expected 233 233
Device Slipped 199 199
No Apparent Adverse Event 187 187
Material Twisted/Bent 173 173
Device Dislodged or Dislocated 172 172
Packaging Problem 141 141
Patient-Device Incompatibility 138 138
Fitting Problem 120 120
Difficult to Remove 117 117
Material Fragmentation 116 116
Loose or Intermittent Connection 106 106
Unintended Movement 101 101
Material Deformation 96 96
Detachment of Device or Device Component 93 93
Physical Resistance/Sticking 91 91
Corroded 87 87
Use of Device Problem 82 82
Positioning Failure 81 81
Detachment Of Device Component 80 80
Mechanical Problem 76 76
Difficult to Insert 75 75
Device Inoperable 71 71
Manufacturing, Packaging or Shipping Problem 71 71
Positioning Problem 63 63
Loosening of Implant Not Related to Bone-Ingrowth 62 62
Malposition of Device 60 60
Entrapment of Device 60 60
Bent 60 60
Osseointegration Problem 55 55
Separation Failure 53 53
Crack 53 53
Improper or Incorrect Procedure or Method 51 51
Inadequacy of Device Shape and/or Size 50 50
Connection Problem 49 49
Component Missing 48 48
Failure to Align 46 46
Patient Device Interaction Problem 42 42
Material Discolored 41 41
Device Contaminated During Manufacture or Shipping 40 40
Delivered as Unsterile Product 38 38
Dull, Blunt 37 37
Device Contamination with Chemical or Other Material 36 36
Mechanics Altered 36 36
Failure To Adhere Or Bond 36 36
Defective Device 35 35
Device Markings/Labelling Problem 34 34
Unstable 34 34
Material Integrity Problem 32 32
Failure to Osseointegrate 30 30
Noise, Audible 27 27
Metal Shedding Debris 26 26
Mechanical Jam 23 23
Naturally Worn 23 23
Tear, Rip or Hole in Device Packaging 21 21
Unsealed Device Packaging 20 20
Off-Label Use 19 19
Disassembly 19 19
Sharp Edges 19 19
Material Separation 18 18
Device Packaging Compromised 17 17
Loss of Osseointegration 16 16
Sticking 15 15
Degraded 13 13
Separation Problem 13 13
Therapeutic or Diagnostic Output Failure 12 12
Defective Component 12 12
Failure to Advance 11 11
Nonstandard Device 11 11
Torn Material 11 11
Difficult To Position 10 10
Device Damaged by Another Device 10 10
Material Protrusion/Extrusion 10 10
Contamination /Decontamination Problem 9 9
Peeled/Delaminated 9 9
Component Falling 9 9
Loss of or Failure to Bond 9 9
Device Expiration Issue 9 9
Device Difficult to Maintain 9 9
Fail-Safe Design Failure 8 8
Premature Activation 8 8
Biocompatibility 8 8
Device Operational Issue 8 8
Material Rupture 7 7
Flaked 7 7
Misconnection 6 6
Difficult to Advance 6 6
Component or Accessory Incompatibility 6 6
Deformation Due to Compressive Stress 6 6
Split 6 6
Device Or Device Fragments Location Unknown 6 6
Device Handling Problem 6 6
Pressure Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3972 3972
Pain 2004 2004
Non-union Bone Fracture 1705 1705
Failure of Implant 1589 1589
No Known Impact Or Consequence To Patient 1522 1522
Unspecified Infection 1401 1401
Bone Fracture(s) 901 901
Impaired Healing 796 796
No Clinical Signs, Symptoms or Conditions 762 762
No Information 737 737
No Consequences Or Impact To Patient 678 678
Injury 611 611
Discomfort 380 380
Loss of Range of Motion 309 309
No Patient Involvement 300 300
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 258 258
Post Operative Wound Infection 255 255
Device Embedded In Tissue or Plaque 243 243
Necrosis 243 243
Foreign Body In Patient 212 213
Swelling 189 189
Nerve Damage 177 177
Insufficient Information 155 155
Arthritis 121 121
Hypersensitivity/Allergic reaction 120 120
Irritation 117 117
Reaction 111 111
Fall 97 97
Wound Dehiscence 94 94
Physical Asymmetry 82 82
Malunion of Bone 80 80
Osteolysis 73 73
Skin Irritation 70 70
Inflammation 63 63
Implant Pain 63 63
Hematoma 62 62
Tissue Damage 60 60
Not Applicable 54 54
Hypoesthesia 52 52
Hemorrhage/Bleeding 47 48
Dysphagia/ Odynophagia 47 47
Skin Inflammation/ Irritation 46 46
Limited Mobility Of The Implanted Joint 45 45
Patient Problem/Medical Problem 44 44
Joint Dislocation 43 43
Swelling/ Edema 40 40
Ossification 37 37
Rash 37 37
Rupture 35 35
Unspecified Tissue Injury 35 35
Inadequate Osseointegration 34 34
Calcium Deposits/Calcification 33 33
Death 33 33
Bacterial Infection 31 31
Adhesion(s) 29 29
Cellulitis 24 24
Pneumothorax 24 24
Muscular Rigidity 24 24
Fracture, Arm 24 24
Deformity/ Disfigurement 22 22
Neuropathy 22 22
Itching Sensation 22 22
Sepsis 22 22
Erythema 22 22
Laceration(s) 21 21
Abscess 20 20
Sedation 20 20
Ambulation Difficulties 20 20
Erosion 19 19
Cerebrospinal Fluid Leakage 19 19
Foreign Body Reaction 18 18
Joint Disorder 18 18
Muscle/Tendon Damage 18 18
Fistula 17 17
Weakness 17 17
Chest Pain 16 16
Visual Impairment 15 15
Thrombosis 15 15
Numbness 15 15
Blood Loss 15 15
Tingling 13 13
Pocket Erosion 13 13
Paralysis 13 13
Scar Tissue 13 13
Fatigue 13 13
Eye Injury 12 12
Edema 12 12
Burning Sensation 12 12
Skin Erosion 11 11
Metal Related Pathology 11 11
Missing Value Reason 11 11
Skin Infection 11 11
Complaint, Ill-Defined 10 10
Staphylococcus Aureus 10 10
Skin Discoloration 10 10
Fever 10 10
Purulent Discharge 10 10
Headache 9 9
Neurological Deficit/Dysfunction 9 9
Pneumonia 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Feb-14-2017
2 Arthrex, Inc. II Apr-09-2021
3 Arthrex, Inc. II Jul-29-2020
4 Arthrex, Inc. II Apr-08-2016
5 Biomet II Jun-09-2020
6 Biomet, Inc. II Jan-21-2021
7 Biomet, Inc. II May-26-2016
8 Epic Extremity, LLC II May-15-2018
9 Flower Orthopedics Corporation II Oct-06-2021
10 Flower Orthopedics Corporation II Aug-12-2020
11 I.T.S. GmbH II Jun-04-2019
12 In2Bones, SAS II Aug-03-2017
13 In2Bones, SAS II Jan-06-2017
14 Integra LifeSciences Corp. II Jun-14-2016
15 K2M, Inc II Apr-12-2021
16 Miami Device Solutions, LLC. II Dec-05-2019
17 NewDeal SA II Jul-16-2018
18 Nextremity Solutions II Feb-11-2020
19 Nextremity Solutions II Nov-22-2019
20 Orthofix, Inc II Jun-07-2018
21 Smith & Nephew, Inc. II Dec-10-2021
22 Smith & Nephew, Inc. II Nov-18-2021
23 Smith & Nephew, Inc. II Sep-09-2020
24 Smith & Nephew, Inc. II Jan-24-2018
25 Smith & Nephew, Inc. II Jan-19-2018
26 Smith & Nephew, Inc. II Apr-18-2017
27 Smith & Nephew, Inc. II Apr-14-2017
28 Stryker GmbH II Jan-07-2020
29 Synthes (USA) Products LLC II Aug-17-2020
30 Synthes (USA) Products LLC II Aug-11-2016
31 Synthes (USA) Products LLC II Jun-10-2016
32 Synthes, Inc. II Jan-29-2020
33 Toby Orthopaedics, Inc. II Dec-04-2019
34 TriMed Inc. II Nov-13-2019
35 TriMed Inc. II Oct-10-2019
36 TriMed Inc. II Apr-23-2019
37 TriMed Inc. II Aug-18-2018
38 Trimed Inc II Sep-20-2016
39 Wishbone Medical, Inc. II Jun-04-2021
40 Wright Medical Technology Inc II Dec-17-2021
41 Wright Medical Technology, Inc. II Dec-20-2021
42 Wright Medical Technology, Inc. II Nov-25-2019
43 Zimmer Biomet, Inc. II Nov-07-2019
44 Zimmer Biomet, Inc. II Aug-31-2018
45 Zimmer Biomet, Inc. II Apr-03-2018
46 Zimmer Biomet, Inc. II Jan-14-2016
47 Zimmer Manufacturing B.V. II Mar-12-2016
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